Anxiety CALM Intervention Manual - Regal Medical Group

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PETER P. ROY-BYRNE M.D.
MICHELLE G. CRASKE Ph.D.
MURRAY B. STEIN M.D., M.P.H.
GREER SULLIVAN M.D., M.H.S.
Adapted from IMPACT Intervention Manual:
By Jurgen Unutzer M.D., M.P.H

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TABLE OF CONTENTS
1. Project Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
2. CALM: Team Roles . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
3. Stepped Care for Anxiety: Overview . . . . . . . . . . . 15-20
4. Introduction to Working with Anxious Patients . . . 21-25
5. The Initial Patient Contact: Setting the Stage . . . . . 26-31
6. Course of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . 32-38
7. Psychopharmacology Stepped Care Approach. . . 39-47
8. Psychiatric Evaluation . . . . . . . . . . . . . . . . . . . . . . . 48-49
9. Documenting and Tracking Clinical Encounters … 50-51
10. Anxiety Management Guide for the PCP . . . . . . . . . 52-61
11. Handling of Emergencies . . . . . . . . . . . . . . . . . . . . . 62-64
12. Supporting Materials . . . . . . . . . . . . . . . . . . . . . . . . . 65-66
13. Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

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1. PROJECT OVERVIEW
THE CLINICAL IMPORTANCE OF ANXIETY IN PRIMARY CARE
Anxiety disorders are prevalent, highly co-morbid with one another, and
often chronic in the primary care setting.
Both depression and anxiety disorders more commonly present in primary care
clinical settings than in mental health specialty settings. Although the treatment of
depression in primary care settings has received much more attention, anxiety
disorders as a group are more common than depression with a lifetime
prevalence of 29% versus 21% for depression. Furthermore, anxiety disorders
are often more chronic, persistent, and less episodic than depressive disorders.
The most common anxiety disorders presenting in primary care clinical settings
are panic disorder, generalized anxiety disorder, social anxiety disorder, and
post-traumatic stress disorder, each with an estimated primary care prevalence
of at least 5%. At least half of the people presenting with an anxiety disorder in
primary care will have more than one anxiety disorder, and over 50% of persons
with one anxiety disorder have co-morbid depression. Appropriately treating
anxiety will likely have an impact on many depressed patients since the effective
treatment approaches share certain similarities. This is particularly true for those
patients who are the most severely ill, since anxiety with co-morbid depression
has more severe symptoms, greater functional impairment, and a more chronic
and persistent course.
Anxiety disorders are associated with functional disability, impaired quality
of life, and increased costs related to over utilization of medical services.
Anxiety is associated with impairment in physical, mental and social functioning.
Because the onset of many anxiety disorders occurs during the critical
developmental stages of adolescence or young adulthood, persons with anxiety
disorders may not achieve their full level of functioning. Reflecting this, many
studies show a disproportionate number of persons with anxiety disorders are
unable to hold a job and receive public assistance and/or disability support.
Some anxiety disorders are associated with increased use of medical services,
as common anxiety symptoms such as shortness of breath or chest pain may
mimic important physical health symptoms. The resulting increase in
unnecessary medical costs makes anxiety a major public health problem.
Anxiety is poorly recognized and inadequately treated in primary care
settings.
Anxiety is less readily recognized than depression by both primary care providers
(PCPs) and community mental health clinicians. A number of reports have
documented that anxious patients see a number of non-psychiatric physicians
before being appropriately diagnosed. The limited data we have on rates of

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primary care anxiety treatment suggest that medications are used infrequently
(i.e., in only about 30% of cases), and often incorrectly. Utilization of effective
psychological treatments is even less frequent. Finally, evidence indicates that
anxiety treatment is complicated by poor adherence, which often leads to poor
outcomes.
Despite the availability of evidence-based treatments for anxiety disorders
and preliminary effectiveness trials focusing on panic disorder, “userfriendly”
models of delivering evidence-based anxiety treatments that can
be easily applied in primary care have not been systematically investigated.
Most patients have more than one anxiety disorder, frequently along with
depression, making it confusing for the PCP to decide where to focus treatment
and how to combine treatments for separate disorders. The competing demands
of co-morbid medical conditions also limit the extent to which anxiety can be
addressed. Patients’ receptivity to anxiety care may depend on their
socioeconomic status, ethnic and cultural background, and attitudes and beliefs
about (or preferences for) different treatments. Different systems of care are
organized in different ways depending on the communities they serve and their
funding sources. A model of care delivery that takes these factors into account is
sorely needed.
PROJECT GOAL
The goal of this research project – entitled “CALM: Coordinated Anxiety Learning
and Management” is to test an approach to assist PCPs deliver more effective
treatment to persons with anxiety disorders.. We have developed a unified
approach to detecting and treating a range of commonly occurring anxiety
disorders (specifically panic disorder, generalized anxiety disorder, social phobia,
and posttraumatic stress disorder) that is likely to be feasible and effective in
primary care settings. The project will have unique features not previously
utilized in first generation anxiety effectiveness studies in primary care. These
include fewer exclusion criteria so that a broader range of patients will be eligible
to participate, attention to patient’s preferences for treatment options, patient
activation/motivational enhancement, and individually tailored psychological or
psychopharmacological treatment.
A key feature of the intervention is the anxiety clinical specialist (ACS) who will
(1) assist the PCP by monitoring medication tolerability and adherence (for
patients where medication is prescribed) and (2) provide cognitive behavioral
therapy (CBT) when appropriate. The study is designed to be conducted with a
diverse population of subjects in urban and rural areas and university and
community settings. We hope to involve approximately 40% ethnic minority
and/or Spanish-speaking patients.

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PROJECT ORGANIZATION
CALM is funded by a grant from the National Institute of Mental Health (NIMH). It
is carried out by research teams in Seattle, Los Angeles, San Diego, and Little
Rock, with each team working with several primary care clinic sites.
To maximize ethnic and socioeconomic class diversity, several sites are using
low-income community health centers or special ethnic-minority HMOs as
primary care recruitment sites. In each city, approximately 250 adults with one of
the four common anxiety disorders in primary care will be identified by the
primary care physician (PCP) and referred. PCPs may refer patients with known
anxiety disorders directly to the study; if desired, they may use a simple five-item
screen provided by study personnel to facilitate identification of anxiety disorders
among their patients. Patients interested in participating are evaluated for
eligibility by the ACS. Eligible patients then receive a baseline phone
assessment from RAND survey interviewers and are then randomized to the
CALM intervention or treatment as usual (TAU).
All subjects (in both CALM and TAU arms of the study) are assessed
independently by telephone by specially trained RAND interviewers (who will not
know about treatment assignment) at baseline (before starting treatment), and at
6, 12, and 18 months. These interviews will include the primary outcome
measures for the study.
OVERVIEW OF THE INTERVENTION STRATEGY
The intervention (CALM) will be delivered by a diverse team of professionals at
the primary care clinic. An anxiety clinical specialist (ACS) in the primary care
clinic will conduct an initial assessment and, during an initial visit, will provide
education, activation and preparatory techniques to encourage patients to pursue
one of the available evidence based treatments. The ACS will coordinate all care
for anxiety with the patient’s regular primary care provider (PCP), keep him/her
informed of the patient’s progress through e-mail, fax, or other methods, and
provide sustained monitoring and follow-up of the patient. Depending on the
patient’s treatment choice, the ACS will either support anti-anxiety medication
treatment by the PCP (who consults with the study psychiatrist as needed) or will
deliver a manual-based form of CBT for anxiety. The ACS will receive
supervision from a team psychiatrist. An expert psychologist at each site will
additionally provide weekly CBT supervision for the ACS. Supervision can occur
by telephone or in person depending on preference and logistics. A PCP
“champion” will serve as a liaison between team members, other clinic PCPs
and clinic staff and will meet with the ACS and team psychiatrist on a regular
basis (e.g., once monthly). The team psychiatrist will be available to consult in
person on patients who do not improve with a first treatment intervention and will
then arrive at a plan for further treatment (augmenting the initial modality or
adding the alternative modality) with the rest of the team.

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2. COORDINATED ANXIETY LEARNING & MANAGEMENT
(CALM)
THE INTERVENTION TEAM
This chapter will describe in more detail the roles and responsibilities of each
member of the intervention team. Please note that this intervention includes the
patient as an active collaborator in treatment. To encourage patients to more
actively participate in their treatment, those in the intervention arm of the study
will receive an initial educational intervention via the ACS. This intervention
(described more fully in Chapter 5) will include education about anxiety disorders,
motivational enhancement, and assistance in identifying and overcoming barriers
to treatment. In addition, patients in the intervention arm will receive educational
materials (e.g., brochures) that describe the nature and treatment of the various
anxiety disorders. They will also have the option of viewing a video tape (and/or
access to a study web site) that also details the clinical characteristics and
presentation of these disorders, their ability to mimic medical disorders, and the
good clinical response to both pharmacologic and cognitive behavioral
treatments.
PATIENT’S PRIMARY CARE PROVIDER (PCP)
The intervention is organized to support each PCP in the care of his or her
anxious patients. Thus, the PCP will be at the center of the intervention team
and will be responsible for initiating and maintaining pharmacologic anxiety
treatment, in addition to usual treatment of comorbid or underlying medical
problems and referrals to specialty care. All medication treatment decisions will
be made by the PCP, using their own clinical experience and information in this
manual. The PCP also plays an important role in encouraging the patient’s
participation in the intervention activities. All PCPs will receive an initial training
and orientation session on the project, as well as focused instruction on the
pharmacological treatment of anxiety disorders. The PCP will have quick access
(by phone or in-person if requested) to the study psychiatrist for “curbside
consults”.
We encourage PCPs to refer patients whom they already know to be anxious.
We also strongly recommend the use of brief screeners within the clinic for
identification of additional patients. This is important because the majority of
anxiety disorders presenting in primary care clinics go undetected in routine care.
For each patient referred to the study the primary care provider will receive
information on: (1) whether a referred patient came for the screening
appointment; (2) what the results of the screening interview were (i.e., MINI
diagnoses and whether the patient is eligible for the study); (3) to which group
the patient (if eligible) has been randomized. For those patients who enter the
study and who are randomized to the intervention arm, the primary care provider
can expect to receive regular feedback from the ACS regarding the patient’s

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clinical progress. The mechanism for this feedback will be tailored to
accommodate the preferences of the PCP.
Additional information in this manual especially relevant to the PCP can be found
in Chapters 7 and 10. Chapter 7 describes in detail the stepped care approach
and contains pertinent information about medications typically used to treat
anxiety disorders. Chapter 10 presents an overview of anxiety management for
the PCP and provides a list of questions that patients often ask about anxiety
treatment along with appropriate responses to these questions.
THE ANXIETY CLINICAL SPECIALIST (ACS)
The ACS plays a central role in the CALM study. There are four main
responsibilities of the ACS: (1) explaining the study to each patient referred by
the PCP such that each potential study subject can make an informed decision
regarding participation in the study; (2) for those patients who elect to participate
in the study, conducting an initial assessment to determine eligibility for the
study; (3) for those patients who are randomized to the CALM intervention arm,
to work closely with the patient, PCP and study psychiatrist to manage and
document the treatment process; and (4) for those patients in the CALM
intervention arm who elect to receive cognitive behavioral therapy (CBT), to
deliver the CBT treatment. The ACS will receive training from study personnel
regarding each of these four responsibilities. In addition, the ACS will participate
in ongoing, intensive clinical supervision from both the study psychiatrist and the
expert psychologist. Each of these responsibilities is described below.
(1) Explaining the study. All potential subjects in this study will be referred by
the PCP. The ACS will explain the purpose of the study and the overall design of
the study to each referred patient and will be responsible for obtaining informed
consent for the study. It will, therefore, be necessary for the ACS to be
completely familiar with all aspects of the CALM intervention so that questions
and concerns can be appropriately addressed. The ACS will need to be able to
rapidly develop rapport with referred patients and understand special issues and
concerns that are common to persons with anxiety disorders. (Refer to Chapter
4 for a detailed description of these issues.) Preferably, these discussions with
the potential subjects will occur in person but may sometimes be conducted by
telephone. Training activities related to this responsibility will include role-playing
so that ACS’s can become optimally comfortable with this process.
(2) Conducting an initial assessment. For those subjects who elect to
participate, the ACS will administer the MINI Diagnostic Interview, which is a
structured clinical interview, to determine whether or not the potential subjects
meet inclusion criteria for the study (i.e., are between the ages of 18-75 and
suffer from one of the 4 anxiety disorders under consideration). This interview will
also determine if subjects have a condition that would exclude them from the
study such as schizophrenia, bipolar I disorder, or alcohol or substance
dependence. This interview is expected to require between 30 and 45 minutes.

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At the end of the assessment the ACS should be able to conclusively determine
whether or not the potential subject is eligible to participate. If the ACS has any
questions regarding eligibility, the study psychiatrist and/or the project principal
investigator should be contacted as soon as possible to assist in making this
determination.
The ACS will enter data obtained during this assessment into the secure, webbased
database (described in Chapter 9). This information will be viewed
centrally by study personnel at RAND who will initiate a telephone baseline
interview to collect additional data and then randomly assign each eligible patient
to either the CALM intervention or treatment-as-usual (TAU) arm of the study. All
4 clinical sites in this national study will enter data into this central database such
that randomization occurs centrally for all subjects entering the project.
The ACS will subsequently be informed regarding the results of the
randomization and will then reiterate and review with the patient what to expect,
based on the group they have been assigned to. Those in the TAU arm will
continue usual treatment with their PCP but will be interviewed by phone at
baseline, 6, 12, and 18 months regarding their symptoms and progress. The ACS
is expected to have no further contact with the patients randomized to the TAU
arm of the study. Those who enter the CALM intervention arm will receive
identical phone interviews at baseline, 6, 12 and 18 months but will also receive
the additional clinical services included in the CALM intervention.
All phone interviews for all subjects in the study nationally will be conducted by a
survey research group at RAND, and the information collected in these
interviews will comprise the primary outcome measures of the study. Therefore, it
is imperative that the ACS ensure that accurate contact information is available
for all subjects.
(3) Working closely with the PCP and study psychiatrist to manage the
treatment process. For those patients who enter the CALM intervention arm,
the ACS will be responsible for following the patient and enlisting the assistance
of the PCP and study psychiatrist as needed. Intensive supervision for all
aspects of treatment will be provided as described briefly below.
All patients in the CALM intervention will require management regardless of
whether or not they elect to be treated with medications, CBT, or both. This
section will briefly outline the ACS’s activities needed for optimal, overall
management and the section after will focus on issues specifically related to
provision of CBT.
3a. The ACS will need to be familiar with local resources available to assist study
patients with a number of issues, such as barriers to care (e.g., childcare and
transportation resources), assistance with formal and informal substance abuse
treatment services, and other appropriate local services. One of the first

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activities of the ACS should be to begin compiling a list of pertinent local
resources.
3b. The ACS will need to negotiate an optimal method to provide ongoing
feedback to the PCP regarding patients’ progress and will confer with the PCP
“champion” ( see page 12) to formulate a plan for the particular clinic. It will be
crucial for the ACS to keep each patient’s PCP informed about the patient’s
progress and any questions or problems that arise during treatment, with minimal
effect on physician burden. At the beginning of the study, the ACS should make a
point of personally introducing him/herself to each PCP in the clinic (though this
may not be feasible in large practices with many PCPs), providing a brief
introduction to the study and the role for the ACS. He or she should also ask
each PCP about their preferred method for being contacted about patient-related
matters (i.e., telephone, e-mail, pager, or direct in-clinic communication).
3c. For all patients randomized to the CALM intervention arm the ACS will
provide an initial intervention with the patient. The intervention has multiple
components, including education about anxiety disorders and a discussion of
treatment options. (Because this initial session is so important, we present a
more detailed account of its content in Chapter 5.) During this session, the
patient is presented with the two available treatment modalities, which are
described in sufficient detail that the patient can appreciate their relative
advantages and drawbacks and make an informed decision about which
treatment to pursue. All patients will have the option to receive medication or
CBT or both. The ACS is responsible for assisting the patient in making a
treatment choice that is right for them.
The ACS will also assist patients to identify potential barriers to treatment and
means to overcome them, and will also provide motivational enhancement. The
initial visit with the ACS focuses on patient education and activation, given that
non-adherence with primary care behavioral treatment is common, and such
education and activation have been shown to improve adherence. Motivational
enhancement techniques will be used to identify barriers to treatment, and to
strategize about ways of overcoming these barriers. The patient will be strongly
encouraged to utilize the educational materials, and impediments to doing so will
also be identified (e.g., problems with literacy or the availability of a VCR (VCRs
will increasingly be an issue – DVD possible?) or computer access) so that these
barriers might be overcome (e.g., use of a surrogate significant other for reading,
use of an on-site VCR in the clinic to watch the videotape, recommendation to
access web-based materials through a local public library). Components of this
initial intervention may be repeated during the course of treatment as needed.
3d. Once a patient has chosen a specific treatment option, the ACS is
responsible for initiating the treatment option. This might include informing the
PCP about the need for medication, initiating a course of CBT to be provided by
the ACS, or both, depending on the patient’s previous treatment and current

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treatment preferences. In some clinics, PCPs may have already provided a
medication prescription to the patient at the time of study referral. In all cases,
the ACS will document the treatment plan, using structured forms, which will be
entered into the secure web-based database, and reviewed by the study
psychiatrist. A printed copy will be provided to the PCP who may or may not
elect to put this in the patient’s chart.
3e. The ACS will closely track patients’ clinical progress and will complete
standard ratings at each visit for the purpose of monitoring progress. This will be
accomplished via face-to-face meetings and phone contacts. The ACS may
provide audiotapes of in person or phone sessions, which patients can replay to
remind them of important suggestions, answers to key concerns they have had
about their treatment, etc. The ACS will be responsible for entering information
about follow-up visits and clinical progress into a web-based tracking system that
will allow for easy overview and tracking of the ACS’s patient load. This database
and ratings entered into it will also serve as a basis for the ACS’s weekly
supervision by the study psychiatrist as well as for weekly CBT supervision by
the psychologist.
Some patients are expected to more rapidly achieve clinically significant
improvement than others, who may require additional steps in treatment. In
close consultation with the study psychiatrist and expert psychologist, the ACS
will also need to assist in transitioning patients through the additional steps
needed to achieve clinically significant improvement. Although these steps are
tailored for each patient, their overall design is described in Chapter 3.
Each of the four clinical sites will develop an “action plan” to be used in instances
of clinical emergency, such as when a subject expresses suicidal thoughts. The
ACS is required to assist in development of the local site’s plan and to
consistently assess patients’ status regarding possible emergencies.
3f. After patients reach a level of symptom relief and functioning with which they
(and the PCP) are satisfied, the ACS and the patient will develop a relapse
prevention plan (which will be entered into the Web system) and the ACS will
follow the patient with monthly telephone contacts throughout the remainder of
the year of treatment. Additional in-person contacts designed to reduce relapse
risk will be an option, depending on the patient’s clinical status. The ACS will
continue to document treatment response and services provided to the
intervention patients using a web based clinical information system. In this way,
patients who require additional treatment interventions will be identified, and
modification to the treatment plan can be initiated as required.
3g. The ACS will be expected to participate in regular and ongoing local
supervisory sessions (weekly or bi-weekly) with the local study psychiatrist.
During the meeting, the ACS will go over his or her case load and discuss all new
patients and their treatment plans as well as ongoing patients who are

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experiencing difficulties with their treatments or not responding as expected.
Patient discussions will be linked to clinical status evaluations measured with the
use of simple rating instruments that the ACS will administer (see “Web-based
Clinical Management System” below). The liaison PCP will attend at least one of
these meetings per month to help problem-solve any clinic systems-related
issues. The meetings will also facilitate effective and efficient communication
between all members of the clinical team. The liaison PCP and team psychiatrist
will be available to the ACS during the rest of the week by telephone or email to
answer clinical or logistical questions. The liaison PCP in particular will be most
helpful in answering questions about clinic logistics and comorbid medical
problems, whereas the team psychiatrist will be most helpful with questions
related to anxiety, anxiety psychopharmacologic treatment, and other comorbid
psychiatric disorders.
In addition, the ACS will participate in monthly national study teleconferences
with ACSs and study psychiatrists from all four sites so that each will have the
opportunity to learn from the experiences of their peers across the national study.
These conferences will discuss any perceived problems with study logistics, skills
developed in the process of the study, and tips regarding clinical management.
(4) Finally, for those patients in the CALM intervention arm who select
CBT, the ACS is directly responsible for scheduling and delivering the CBT.
Ideally, the CBT sessions will be delivered in the office of the PCP in space
specifically provided for the study. A typical course of CBT will involve 6
sessions, although in some cases additional CBT may be necessary. The ACS,
who is not expected to have expertise in the delivery of CBT when hired for the
position, will receive intensive face-to-face training in the delivery of effective
CBT. Since many subjects will have co-occurring disorders, the CBT will be
targeted to the disorder identified by the patient as the one most bothersome or
severe (see the CBT Treatment Manual). The ACS will receive ongoing
supervision either in person or by phone by an expert psychologist. This
supervision will cover issues pertaining to the application of CBT to each client’s
needs and the obstacles to therapeutic improvement. In addition, some CBT
sessions will be audiotaped and checked for fidelity to the CBT method by study
personnel.
PRIMARY CARE PROVIDER “CHAMPION”
Each treatment team will have a primary care provider who will function as a
liaison (or study “champion”) between the treatment team, the primary care clinic,
and other PCPs in the clinic. The main role of the physician champion at each
site will be to help solve logistical problems that inevitably arise in the conduct of
a complex study such as this. He or she will also be responsible for keeping the
study fresh in the minds of primary care providers by routinely reminding them
about its goals at clinic meetings. As their level of familiarity and expertise with
anxiety management grows as a result of their learning experiences throughout
the study (e.g., attendance at weekly team meetings where treatment

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approaches are discussed in detail), this physician may choose to take a more
active role in direct supervision of the ACS at their site. The intent is to develop
local expertise in anxiety management at the PCP level that, eventually, may
translate into better “staying power” of the intervention at these sites once the
study is completed. PCP liaisons, like any of the other participating PCPs, will
also carry their own caseload of patients who may be enrolled in the study.
THE TEAM PSYCHIATRIST
The team psychiatrist has three essential responsibilities.
1. Clinical supervision of the ACS:
The psychiatrist will meet or conference by phone weekly (or bi-weekly, as
determined by the caseload) with the ACS and the rest of the study team to
review treatment plans for all newly enrolled cases and all cases not improving
as expected. Specifically, the psychiatrist will provide advice about how to
overcome patient psychological barriers to continuing treatment and how to
maximize patient self-activation by promoting good health habits (e.g., diet,
exercise, regular sleep-wake cycle, staying socially and recreationally active);
provide targeted education about the nature and treatment of anxiety to
reinforce ACS activity; help to interpret effects of medical illness on symptoms
and possible interactions with treatment; evaluate clinical status and progress
thus far in treatment and alert the ACS if there is a need to re-contact the PCP
about medications. The psychiatrist will also be available to the ACS by beeper
to discuss clinical questions or emergencies. In general, the role is to review
the treatment plan and progress, to help the ACS understand when to stay the
course and when adjustments need to be made, and to be available for
emergencies.
2. Consultation to the PCP:
The psychiatrist will be available for consultation (by telephone in most cases
and in-person if requested) regarding medication issues on an as-needed
basis. This consultation will help the PCP use the medication algorithm in this
manual more effectively by reviewing the patient’s clinical status in light of the
algorithm rules, presenting the various options, and determining which
algorithm option to pursue. Psychiatrists will see all patients receiving treatment
beyond the initial step, so phone consultation for initial step patients is entirely
confined to discussion of dose adjustments and, in infrequent cases where
there has been no response by week 6, to switches to a second antidepressant
(or other medication).
3. Direct patient consultation on “treatment resistant” cases

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The team psychiatrist assesses all patients who do not have an adequate
response to treatment after 12 weeks for a one-time on site consultation.
For this purpose, an incomplete response will be defined as failure to achieve a
total score of 8 or lower on the OASIS and a score of 5 on the PHQ-3 (includes
PHQ-2 plus “fatigue” item).
The psychiatrist will also see the subset of patients who are not responding to
two full treatment trials (each 12 weeks in length) in primary care for an extended
consultation (1-2 follow-up visits) in the primary care clinic. If the psychiatrist
decides that a patient’s mental health would be better managed in a specialty
mental health setting, he/she may make a referral to the appropriate setting in
consultation with the treatment team (if such a referral is possible and available).
Extended consultation will not replace activities normally performed by the ACS
such as CBT, but will be focused on a more comprehensive diagnostic evaluation
and assessment (see next section), treatment recommendations, and possibly
more complex psychopharmacological management in collaboration with the
patient’s ACS and PCP.
During an average week, study psychiatrists will spend their time on the project
as follows:
1. Weekly caseload supervision meetings with the rest of the study team
(ACS and PCP) - I hour.
2. PRN consultation to the ACS or PCPs during the week, available on
beeper - 30 minutes.
3. One time consultation (in person) for patients who are not showing a
significant clinical response to the first line treatment initiated in primary
care after 12 weeks – 2 hours.
4. Extended consultation (up to 2 follow-up visits) for patients who do not
show improvement after this initial consultation plus a second 12-week
treatment trial with the PCP and the ACS. These visits are anticipated to
involve less than 20% of the intervention patients – 1 hour.
In addition, psychiatrists will, in collaboration with the ACS at the supervision
meetings, review each patient’s progress at the completion of each step of
treatment so that decisions can be made with the ACS regarding the next
treatment step.
THE EXPERT PSYCHOLOGIST
The expert psychologist provides weekly supervision to the ACS for all ongoing
CBT cases. The expert psychologist will have been involved in the ACS training
and will therefore be in an excellent position to provide supervision. The
psychologist may also consult directly with the patient at Step 2 or 3, if an
adequate response to CBT has not occurred and if, (i) following psychiatric
consultation, there are no medical or diagnostic factors contributing to non-

esponse, (ii) the patient is unwilling to pursue medication options, and (iii)
attaining optimal response will require further CBT augmentation.
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INTERVENTION FLOWCHART AND TIMELINE
Baseline:
--Patient completes a screen that is reviewed by the PCP who makes a referral if deemed
appropriate or the PCP makes direct referral based on his or her own evaluation.
-- Patient is interviewed by the ACS to confirm anxiety disorder and absence of exclusions
-- Patient is interviewed by RAND randomized and scheduled for initial visit
Initial Treatment Course:
(Usually step one treatment)
- Antidepressant or CBT
- ACS has weekly contact
with patient and keeps PCP
informed of progress
Assessment of
Treatment
Response
None or
incomplete
response to
treatment
or worsens
Consultation
with team
psychiatrist
Step 2 or 3
treatment as
indicated
Remission of
Anxiety
Syndrome
Maintenance Phase:
- Relapse Prevention Plan
- Monthly follow-up calls/visits

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3. STEPPED CARE FOR ANXIETY
All patients enrolled in this project will meet diagnostic criteria for one of
the four most common anxiety disorders in primary care (Panic Disorder
[PD], Generalized Anxiety Disorder [GAD], Social Anxiety Disorder [SAD] or
Posttraumatic Stress Disorder [PTSD]). They may differ in their prior history of
mood and anxiety disorders, past treatments, current treatments, and the extent
of medical and psychiatric comorbidities. Some patients already will be receiving
treatment, most likely with antidepressants. Our experience and published
studies indicate that approximately one in three patients with these anxiety
disorders will already be receiving appropriate – though not necessarily optimal –
pharmacological management at the time of study entry. Others may be
receiving treatments of questionable or limited benefit. Others may have had
counseling but still experience substantial symptoms and distress. Some patients
may have a chronic course with early onset, while others may be experiencing
their first episode of anxiety, perhaps in response to a life stressor or in
association with a major medical illness.
The ultimate goals of treatment are to (1) achieve symptomatic remission (see
below) and return to optimal psychosocial functioning and to (2) prevent
relapse and recurrence of anxiety. Because of the variation in each patient’s
clinical circumstances it is not possible to specify a uniform treatment approach
that will be a perfect fit for each patient. The stepped care treatment algorithm
outlined in the next few pages provides a general guideline to be followed in
treating intervention patients. Within this guideline, the treatment team will use
clinical judgment to ensure that patients enter the stepped care algorithm at the
correct step and that each patient has a treatment plan that is personalized to his
or her clinical circumstances. This algorithm does not substitute for clinical
judgment and experience. Rather, it is intended to prioritize evidence-based
approaches to anxiety management, while recognizing that extant guidelines for
anxiety management are, for the most part, consensus documents, given the
absence of strong evidence for many specific treatment situations. There is still
considerable uncertainty about optimal treatment approaches, and our algorithm
constitutes only a common suggested starting point, with the experience of the
team psychiatrist and psychologist (and, over time, the growing experience of the
ACS and the PCPs) determining the course of treatment beyond the initial step.
Published medication treatment guidelines from the American Psychiatric
Association (APA, 1998) exist only for panic disorder and are now six years out
of date and do not discuss the use of newer medications. Consensus guidelines
using a Delphi method exist for PTSD and are five years out of date. The
American Psychiatric Association will issue in late 2006 or early 2007 new
treatment guidelines for panic disorder, but these are not available at this writing.
For panic disorder and PTSD pharmacotherapy, these guidelines have been
adapted and updated with newer information (e.g., Ballenger et al, 2000) to yield
the suggested approaches described here. For GAD and SAD pharmacotherapy,

17
the recommended stepped care algorithms are based on our synthesis of several
consensus statements (Ballenger et al 1998; 2001). Finally, the World Council on
Anxiety met in September 2000 and established consensus guidelines for the
long-term treatment of anxiety disorders (CNS Spectrums 8: 2003). This
includes specific papers outlining recommendations for long term treatment of
panic disorder (Pollack et al 2003), GAD (Allgulander et al 2003), SAD (Van
Ameringen et al 2003) and PTSD (Stein et al 2003).
In terms of psychotherapy, the American Psychiatric Association (APA)
advocates CBT as the psychosocial treatment of choice for panic disorder in their
panic disorder Practice Guidelines (APA, 1998). Further, CBT for panic
disorder/agoraphobia, generalized anxiety disorder, obsessive compulsive
disorder, posttraumatic stress disorder, and social phobia has been deemed wellestablished
or probably efficacious according to stringent guidelines set forth by
the Task Force on Promotion and Dissemination of Psychological Procedures
(Chambless et al., 1998).
Stepped care treatment algorithm
Step 1 (12 weeks—times are rough estimates)
Step 1 is initiated in the primary care clinic in collaboration with the patient’s
PCP. It will be the initial treatment step for the vast majority of intervention
patients. Only the occasional patient who has just completed and failed what
appears to be an adequate trial of Step 1 treatment should be considered to start
at Step 2. If further medication is desired, a consultation with the psychiatrist is
indicated (see Chapter 8). For patients already on prescription medication from
their PCP at the time of study entry who opt for CBT, no consultation would be
necessary. In addition, as described below, patients currently abusing alcohol
will be referred to substance use treatments. Patients already involved in some
non-CBT form of psychotherapy may continue this if they wish.
This step begins with first line medication or CBT 2 , based on the outcome of the
initial patient education session with the ACS, in which patients choose either
medication or CBT after being familiarized with the advantages and
disadvantages of each. If, after a thorough discussion of pros and cons of the
treatments, the patient expresses a strong preference for beginning both
medication and psychotherapy together, this will be accommodated
Initial Treatment Choice: CBT
Patients with a preference for this modality will start CBT in Step 1 (see CBT
Manual in the appendix for details on this treatment modality). The patient who
has a strong preference for starting both treatments simultaneously will start CBT
and pharmacotherapy together.

18
Initial Treatment Choice: Medication
Patients with a preference for this modality will start medication in Step 1. See
Chapter 8 for a detailed discussion of medications, side effect management,
procedures for selection and dosing, and algorithms for the different steps of
medication treatment.
Medication OR CBT
(usually an SSRI-titrated
to therapeutic dose)
Evaluate response to step 1 treatment.
Patients who achieve remission (total score of 8 on the 5-item OASIS and score
of 5 on PHQ-3), go to maintenance treatment. Others go to step 2 unless they
insist they are improved enough and want to stop
MED in step 1 CBT in step 1
Very Good Response?
Very Good Response?
no* yes no yes
Step 2 Maintenance Step 2 Maintenance
(*If no response at 6 weeks (no reduction of at least one point in at least two OASIS
items) or intolerant of first medication tried, switch to another first-line medication,
usually within class (e.g., try a different SSRI)).
MAINTENANCE TREATMENT
Pharmacotherapy: Monthly phone calls should focus on continued medication
adherence, improved health habits and the development of a relapse prevention
plan (see Chapter 6).. Continue for at least one year, based on available relapse
data with maintenance pharmacotherapy. At this point, tapered discontinuation
may be considered if the patient is in or near remission (i.e., there are no residual
anxiety or depressive symptoms present, and the patient reports excellent
functioning to the ACS), does not have a history of recurrent depression or
chronic anxiety, and there is an absence of ongoing medical and psychosocial
stressors that might precipitate an imminent relapse. All decisions to taper
medication should be reviewed with the consulting psychiatrist. If the patient
prefers to stay on medication for the time being, this should not be discouraged.
In this case, re-review by the PCP 3-6 months later should be planned.

19
CBT: Monthly phone booster sessions will be provided by the ACS, focusing on
reinforcement of cognitive behavioral skills and details of the relapse prevention
plan (see CBT manual for details)
Step 2 (12 weeks— times are rough estimates)
Step 2 is preceded by an in-person psychiatric consultation (see Chapter 8)
during which the case is reviewed and there is careful discussion with the ACS
and patient about the patient’s preferences for adding the other modality or
augmenting (or amplifying, in the case of providing additional CBT sessions) the
current modality they are already receiving (12 weeks).
Treatment Selection at Step 2:
Decisions at Step 2 are guided by whether a patient has failed to respond (i.e.,
no reduction of at least one point on at least two OASIS items or poor treatment
tolerability) or whether they have had a partial response but failed to achieve
remission (total score of 8 or lower on the 5-item OASIS and score of 5 or lower
on PHQ-3). As in all steps, patient preference is a major guide in determining the
next treatment to be pursued, although patients will be encouraged to accept
treatment with the modality (medication or CBT) they have not tried, given the
data on the advantages of combined treatment in panic disorder, and
uncontrolled reports of benefit in partially responsive cases of other anxiety
disorders. However, some CBT patients may prefer not to take medication, and
require additional CBT. Likewise, some medication patients may prefer not to
pursue CBT and will require additional medication. The procedures for
augmentation of CBT with additional CBT are outlined in the CBT manual (where
this is being considered, the psychologist will be involved in the decision).
Procedures for additional medication treatments are provided in Chapter 8.
(Medication in Step 1) (CBT in Step 1)
Partial response to step 1
Pharmacologically
augment AD
or
add CBT
No response
Switch to CBT
or
Switch to different
AD type
Partial response
Additional CBT
sessions (augment)
and/or
add 1 st line AD
No response
Additional CBT
sessions
(switch focus)
and/or
add1 st line AD
Evaluate response to Step 2 treatment
Patients with full response go to maintenance treatment.
Others are considered for Step 3.

20
Step 3 and 4 6 (24-36 weeks)
Consider:
Further CBT augmentation, but only in select cases approved by the
expert psychologist after seeing the patient in consultation (MICHELLE?)
Trial of 2 nd or 3 rd type of antidepressant
Combination of medication and CBT (if not already tried in step 2)
Other augmentation of antidepressants (if patient has had a partial
response to an antidepressant in step 2) 5
Referral to specialty mental health care for more ongoing treatment if
there is a need for couples or family therapy, more specific substance
abuse treatment, or there are complex psychological issues such as
childhood sexual abuse or maltreatment.
.
Even patients who have been referred for specialty mental health care (e.g.,
additional psychotherapy) will remain in the study. The ACS will follow them with
regular (at least monthly) telephone calls and keep the patient’s regular PCP
apprised of progress.
7 Additional Treatments to be Considered During the Intervention:
Additional treatments that may be considered by the ACS or the treatment team
at any stage in the treatment course include:
1. Referrals to self help groups such as AA and NA
2. Referrals to support groups run by ALANON or caregiver support groups
3. Referrals to other community resources
Each ACS should develop and maintain a local resource list for such referrals
(see Appendix A).
SPECIAL POPULATIONS
1. Patients with comorbid depression: In general, patients with comorbid
depression who opt for medication should be treated using antidepressants
such as SSRIs or SNRIs. In non-responsive patients, supplementation with a
second antidepressant rather than a benzodiazepine may be preferable.
Consultation with the team psychiatrist can be helpful in making treatment
plans for patients with comorbid depression and anxiety disorders. Patients
electing a course of CBT whose depression does not concurrently improve
with their anxiety, should be encouraged to consider an antidepressant
medication.
2. Patients with comorbid alcohol or substance abuse: A patient with
anxiety and comorbid alcohol abuse should be routinely referred for
treatment of alcohol abuse.They should usually be referred for alcohol abuse
specialty treatment as available and to a self-help group such as AA or NA.
At times, it is prudent to initiate substance abuse treatment before starting an

21
antidepressant because symptoms of anxiety may occasionally remit with
successful treatment of the alcohol or substance abuse. At other times,
however, untreated anxiety symptoms can fuel substance abuse and make
adherence to (and even attendance at) AA unlikely. The decision when to
start anxiety treatment is a complex one, and the team psychiatrist should be
consulted to assist with this decision.
3. Patients with bipolar II (“atypical bipolar”) disorder Although the
diagnostic interview at study entry should identify patients with a bipolar
diagnosis and eliminate anyone with unstable bipolar illness, atypical bipolar
illness remains a major cause of treatment-refractory anxiety symptoms.
Such individuals are often suffering from “mixed states” and the use of
anticonvulsant medication or lithium is frequently required for symptom
control. Such individuals may need to be referred to specialty mental health
settings, although select cases could be initially managed by the PCP in
conjunction with the psychiatrist who can recommend an initial trial of either
lithium, valproate or an atypical anti-psychotic. If these patients are not
referred to specialty treatment, they should have a consult with the study
psychiatrist, face to face, before a recommendation is made.
Patients with recurrence during the course of the one-year treatment
program return to the step after the one they stopped at (likely Step 2 or
Step 3).

22
4. INTRODUCTION TO WORKING WITH ANXIOUS PATIENTS
Working with Anxious Patients:
To empower each patient to be an active participant in treatment, it is vital to
establish a therapeutic alliance with the patient. Persons with anxiety, like many
individuals with mental disorders, feel ashamed and stigmatized by their
symptoms. They have often functioned quite well before symptom onset and
frequently experience a strong sense of isolation because of their difficulties.
While there is often an immediate beneficial effect when someone seeks them
out, explores their symptoms with them and provides encouragement and advice
about effective treatment and overcoming their anxiety, the nature of anxiety
symptoms can cause therapeutic obstacles. These can include excessive
reassurance-seeking from the mental health professional that, while providing
temporary relief, is reinforcing of this behavior and maladaptive over time;
indecisiveness that may look like procrastination or lack of motivation, but instead
often represents fear of making mistakes or failure; and, most importantly,
avoidant behavior such that patients may appear resistant or non-adherent when
they are choosing avoidance due to excessive fear and anxiety. Also, prominent
symptoms of over-arousal may make it difficult for patients to focus and efficiently
process information during sessions. Symptoms of depression that often
accompany anxiety may also cause difficulties with motivation and initiative and
may need to be distinguished from avoidance.
During the initial contacts, the ACS communicates his or her enthusiasm and
interest in the patient’s well being. Throughout the initial assessment and
psychoeducational session, the patient should begin to understand that the ACS
is someone with whom they will be in ongoing contact. This person will know the
particulars of their situation and can help them access resources in the study and
communicate with the rest of their care team. It is important for the ACS to be
seen as an empathic, trustworthy, knowledgeable and capable advocate who will
work collaboratively with the entire treatment team. Empathy is important in initial
sessions of CBT, but confidence and directiveness become more important
features in later sessions. This stance will facilitate the patient’s adherence to
either medication or CBT treatment when “rough spots” are encountered and
discouragement sets in. The ACS can help the patient stay focused on treatment
goals and support efforts to reach them. Importantly, the ACS will teach skills for
managing distress rather than provide direct reassurance, which only
encourages dependency and relapse.
It is vital to understand each patient’s perspective and how their anxiety
symptoms fit in with their life. Only then can the clinician’s understanding of
anxiety be articulated in a meaningful way so that the patient will become an
active collaborator in treatment. Communications need to be uncomplicated and
non-judgmental. The patient should feel like an active member of the treatment
team with an important role directing treatment. Patient self monitoring of their

23
behaviors is one way of facilitating their input. A biopsychosocial model that
emphasizes the hard-to-control factors of innate genetic vulnerability, along with
the role of psychosocial stressors and coping style (which the patient may have
more control over with help from the ACS and their own self-activation) provides
a useful framework for discussing the diagnosis of anxiety with patients.
Medication and CBT target different aspects of this “cycle of anxiety” but both
ultimately rely on the patient making ongoing life changes.
In discussing anxiety with patients, it is helpful to mention that:
anxiety is common
anxiety can cause or aggravate a wide range of symptoms, including
physical symptoms
anxiety affects the body, behavior and thinking
anxiety is a set of behaviors and ways of thinking that are reinforced over
time, not a character defect or weakness
recovery from anxiety is the rule, not the exception
the good news is that anxiety can almost always be treated with either
medications or CBT (or some combination )
At times, the ACS may find that he or she does not feel as effective with some
patients. The ACS may even become concerned by the patient’s anxiety, and
fail to provide the necessary reinforcement and encouragement to anxious
patients to directly face anxiety provoking situations rather than avoid them. The
ACS will discuss such concerns during the weekly team meeting in order to get
support and avoid any negative outcomes for either the ACS or the patient.
Usually, exploring one’s own reactions with a skilled colleague helps future
patient interactions go more smoothly. Most often the issue in treating anxiety is
the patient’s unwillingness to complete assigned tasks. Rather than view this as
“resistance” the ACS will be taught to conceptualize it as a part of the avoidance
of the anxious syndrome and help the patient think of ways to overcome this
avoidance.
An important issue the ACS must address early on with each patient is the
limitations of what can be done for the patient within the parameters of the
intervention protocol. If there are questions about this, they will be brought up by
the ACS early on in the intervention team meetings and discussed with the
patient.
In working with anxious patients it is crucial to provide the specific focus and
goal-setting that may be difficult for them because of the way anxiety affects their
ability to process information and stay on task. It is therefore important to set the
agenda for each patient visit, focusing on the patient’s anxiety symptoms
(including avoidance), the resolution of which is the goal of treatment, whether
medication or CBT. This means allowing but limiting discussion of other life

24
issues, so that these issues do not become a major focus of meetings, and thus
detract from the CBT.
Working with Ethnic Minority Patients and Those Disadvantaged by Income:
One must always be mindful of patients’ cultural backgrounds. Culture is not
synonymous with ethnic group. Individuals within ethnic groups vary
considerably in their values, identity, and behaviors. One way to think of culture
is the meaning that people give to events and life experiences. Thus, being
familiar with a patient’s cultural beliefs about medicine and mental illness will help
the ACS to communicate effectively with the patient and will increase the
probability that patients will adhere to treatment. When therapists understand
how patients define their symptoms, the salience they give to events, and their
life experiences, they are better able to negotiate an effective treatment plan and
provide quality care. While it is impossible to know all nuances of each culture,
there are overarching themes to keep in mind when working with ethnic minority
and disadvantaged populations. These include distrust of mainstream
organizations and research, mental health stigma, access barriers, perceptions
of mental illness, and acculturation.
Distrust: It can sometimes take a long time to establish a relationship with
disadvantaged and ethnic minority patients, particularly if the ACS is seen as part
of a research project, rather than a treatment team. A common perception is that
research studies recruit disadvantaged individuals to be “guinea pigs” and many
people resist putting themselves in such a position. Also, some ethnic minorities
have been mistreated in medical studies and recruited into studies that ultimately
made incorrect conclusions supporting racial inequality. This mistrust is
especially strong regarding medication use, which may be perceived as a means
to control the patient. Finding ways to articulate and encourage the theme of
patient self-activation serves as one antidote to this perception. Conversely,
sometimes the opposite can happen. That is, because so few individuals have
reached out and offered to help, a disadvantaged individual can sometimes
expect more than can be realistically delivered. Therefore, the ACS must set
clear and realistic expectations from the beginning of treatment so that the
patient does not feel betrayed or short-changed.
Stigma: For many, seeking mental health treatment in the general medical
setting is safer than attending a specialty mental health clinic. It is important to
discuss with patients their beliefs and attitudes about anxiety and any fears they
may have about people in their community finding out they are in treatment for
anxiety. It is likely that psychoeducation will help to dispel misconceptions about
mental health treatment and will orient patients to psychotherapy and medication
approaches. While some of the cultural stigma around treatment for mental and
emotional problems may be counteracted by use of psychoeducational materials,
these materials may have to be reviewed in the sessions if patients are unwilling
to bring them home because of a concern that these materials will be found by

25
family or friends. The ACS should seek to personalize psychoeducational
material and the intervention.
Access Barriers: Many disadvantaged patients may have difficulty making
regular appointments because of the many demands on their time (e.g.,
responsibility for child care) and the unavailability of resources such as childcare
and transportation. The treatment sessions may be viewed as just one more in
an endless series of stressors and obstacles they must overcome in their daily
life. Cost of care is also a crucial issue and should prompt careful consideration
of ongoing medication expenses and the availability of cheaper, generic forms.
When patients present with competing and complex demands, it will be important
to offer them compelling reasons to support their treatment participation. For
example, treatment for anxiety may enable them to develop better coping skills,
allow them to be a stronger support for their family, and improve their overall
quality of life. Patients may need frequent encouragement and praise for their
efforts to adhere to treatment in spite of many competing demands. For
individuals with strong family ties and a predominant focus on the family (e.g.,
Latina women), the ACS may emphasize that helping themselves will in turn help
the family.
Cultural Beliefs: An understanding of a patient’s clinical presentation in the
context of his/her cultural and/or religious background may have important
implications for diagnosis, adherence and treatment outcome. For example,
some Latinos may explain their anxious symptomatology using cultural idioms of
distress such as “ataques de nervios” (includes symptoms such as
uncontrollable shouting, attacks of crying, trembling, heat in chest rising into
head, aggression, being out of control, dissociative experiences, fainting, suicidal
gestures, etc.) and “nervios” (includes symptoms such as headaches, irritability,
stomach disturbances, sleep difficulties, nervousness, easy tearfulness, inability
to concentrate, trembling, tingling sensations, dizziness with occasional vertigolike
symptoms). In such instances, these symptoms may fall within a normal
range of distress relative to the norms of their cultural group; however, in other
cases, their symptoms may extend beyond normative levels of severity and
signify the presence of an anxiety, mood, and/or somatoform disorders. Similarly,
some individuals may emphasize the importance of spiritual issues when
explaining their distress (e.g., anxiety and depression may be attributed to a
spiritual crisis). Acknowledging the significance of the belief system and
integrating it into overall conceptualizations may foster provider-patient trust and
better clinical care.
Acculturation: Patients less acculturated to mainstream American society may
be particularly unfamiliar with the process of seeking mental health treatment.
These individuals may be more likely to experience problems with access and
stigma related barriers to treatment. Simultaneously, individuals may be exposed
to numerous acculturative stressors including the immigration process itself,
intergenerational conflicts, unemployment, discrimination, and alienation that

26
may contribute to anxiety in their lives. Less acculturated patients may need
more education about the treatment process itself as well as the logistics of
receiving treatment.
Working with Family Members and Significant Others:
In most cases, it will be helpful for the ACS to involve family members or
significant others in the treatment of the anxious patient. The ACS should always
discuss with the patient how family members and significant others will feel about
the diagnosis of anxiety and any proposed treatments. The ACS may encourage
the patient to share educational materials or the videotape with significant others
or suggest to talk or meet with important family members to educate them about
anxiety and to ask them to support the patient’s treatment plan. This could
include help with adherence to medications or perhaps plans made during CBT
treatment, such as the help of significant others as coaches or facilitators during
in vivo exposure to anxiety producing situations, as long as it does not enhance
dependency on the significant other. Involvement of significant others in aspects
of behavioral health has also been shown to increase attendance

27
5. INITIAL PATIENT CONTACT: SETTING THE STAGE
Patients will either be referred to the study by their PCP, or “self-referred” with
the agreement of their PCP, as would be done in usual practice. The patient is
then interviewed by the ACS to determine eligibility for the study. This interview
(which includes the MINI diagnostic interview) will take place either in the clinic,
possibly at the same visit (if the patient has time) or over the phone in the next
few days. The ACS should make every effort to meet the patient in person in the
clinic, if only to arrange to contact him or her by telephone. Following the
completion of this initial eligibility assessment, the patient (if eligible) is assessed
by the phone interviewers at RAND to assess baseline clinical status and to be
randomized to the intervention or treatment as usual. If the patient is assigned to
the intervention, the ACS will re-contact the patient by telephone to arrange an
initial visit at the primary care clinic. The goals of this initial call/contact are as
follows:
1. Arrange for a scheduled appointment
2. Answer any questions or concerns the patient may have at this point.
INITIAL VISIT WITH ANXIETY CLINICAL SPECIALIST (ACS) – (USUALLY WEEK 1)
This visit will focus on initial clinical assessment, patient education about various
treatment options, and discussion of initial treatment plans. The visit is also
designed to increase the patient’s motivation and commitment to treatment.
Goals:
The goal of the first visit with the patient is to: establish a working alliance,
restate their principal anxiety problem and place it in his or her unique medical
and psychosocial context; identify and strategize about perceived barriers to
receiving treatment; educate about CBT and medication so that he or she can
make an informed choice and be more prepared for treatment; increase
motivation and readiness to change;and provide information to enhance outcome
and self efficacy expectancies for treatment.
This is to be a collaborative process during which the ACS and patient discuss
issues together. The ACS should refrain from providing information outside the
domain of anxiety and depression and their symptoms and treatment. However,
in some instances, present concerns of the patient are so pressing that it would
hinder the therapeutic alliance were the ACS not to address these concerns. In
such instances, the ACS may briefly divert from the anxiety and depressionfocused
treatment to provide support and guidance about other prevailing life
concerns. Every effort should be made to get back on track with treatment within
the same session, ideally by discussing the patient’s anxiety/depression and/or
decisions about treatment modality in the context of these current concerns.

28
Summary Statement:
The ACS begins by asking patients to provide a description of their presenting
problems; the ACS reflects what the patient is saying and responds with
empathy. Then the ACS provides feedback of the results from the baseline
assessment to the patient, avoiding psychological jargon and stigmatizing
language as much as possible. This includes a brief review of the current
symptoms and symptom complexes (disorders) that the patient has endorsed on
the MINI diagnostic interview and asking the patient whether he or she feels that
his or her problems have been captured accurately. In addition to reviewing
symptoms, the ACS reviews the patient’s history of prior anxiety or depression
episodes, prior treatment history, co-existing medical or social problems that may
serve as stressors that exacerbate anxiety, difficulties with social, personal,
family, or work functioning, and availability of social supports. Finally, the ACS
provides a summary statement of the patient’s concerns, which includes the
principal anxiety symptoms that are most troubling to them, how they are
affecting or restricting important activities and functions, how these symptoms
might be aggravated by recent life stressors (e.g. losses, separations, life
changes, financial pressures, or medical problems), and which family or friends
are available to help support the patient in their treatment and in their drive to
gain more self-control and take an active role in their recovery. During this
process, the ACS should de-stigmatize diagnoses as much as possible and
provide an accurate message of hope for recovery. The stance of the ACS
should be to develop as much discrepancy as possible between the patient’s life
as it currently is (with high anxiety) and the life that they would like to have (with
lowered anxiety) in order to help maximize readiness to change and engagement
in treatment. Helpful techniques to utilize in this portion of the session include:
Express Empathy: Here, the ACS seeks to communicate respect for the
client, with a style that is a blend of “supportive companion” and
“knowledgeable consultant”. Persuasion should be gentle, subtle, and
carried out with the assumption that it is only the client who can decide to
change and affect change.
Develop Discrepancy: During the discussion of the MINI and other
anxiety scores, the ACS should seek to enhance the patient’s perception
of the discrepancy between “where they are and where they want to be”.
Avoid Argumentation: Since argumentation and direct confrontation
tend to increase resistance and decrease readiness to change, the ACS
here does not make any attempt to force the patient to accept or admit a
diagnostic label, prove, or convince the patient of anything. Instead, the
ACS seeks to help the patient accurately view the consequences of living
with high anxiety (and avoidance). The goal is for the patient to begin
voicing the arguments for change themselves, rather than the ACS.
Roll with Resistance: The key point here is that ambivalence about
change is viewed as normal, not pathological, and to be explored openly.
The ACS will invite (but not impose) new ways of thinking about
problems and how to solve them, and seek to evoke solutions from the
patient. Techniques might include simple reflection, reflection with

29
amplification, double-sided reflection, shifting focus, and “rolling
with”.
Support Self-Efficacy: Maximum motivation and commitment to change
require a specific belief on the part of the patient that he or she can
change their anxiety problems. Eliciting statements that reflect selfefficacy
and describing the kind of things that successful people do in
treatments for anxiety (and that the client can do them) will help increase
a sense of self-efficacy. Once the client chooses a treatment option,
summarizing the reasons for their choice and highlighting any efficacy
suggested in the decision making process is also a good idea.
Comment [s1]: These techniques are
all covered in the MET manual which is
free on the web and not very long. I am
thinking it might be a good reading to
assign. Pretty simple concepts I think and
can be read in about an hour. If you like
the amount of detail I’ve added here, we
could just add a footnote here saying that
these come from the MET manual and
cite it. ---Stacy
Perceived Barriers to Mental Health Treatment:
Next, the ACS discusses with the patient their past and current impressions of
and perceived barriers to treatment for anxiety. To facilitate this, the ACS and
patient will review a perceived barriers checklist that will include the following
items:
1. Logistical
i. time
ii. child/elder care
iii. transportation, travel
iv. scheduling
2. Social
i. privacy/confidentiality
ii. family/significant others objection to treatment
iii. embarrassment or fear of what others would think
3. Psychological
i. beliefs about treatment
ii. adverse personal treatment experiences
iii. adverse prior treatment experiences of family or friend
4. Cultural
5. Other patient-specific barriers or concerns
Comment [s2]: My suggestion would
be to do this after they have seen the
video and have a sense of whether they
will choose CBT or meds. That way, the
discussion might be a bit more focused to
the actual pros and cons of doing the
treatment they will do and serve to further
increase motivation and commitment to
change
Barriers pertaining to financial cost and access as they pertain to the use of
medications will also be considered (e.g. use of medication samples for patients
with limited funds of high medication co-pays).
The ACS will discuss with patients the nature of their perceived barriers,
especially in relation to prior experiences, and brainstorm with the patient
potential ways of dealing with them. For issues of daycare or transportation,
consideration will be given to community resources or the involvement of family
or friends as support mechanisms. For social stigma, consideration will be given
to ways of discussing or not discussing their problem and their treatment with
others, and ways of handling time away from work or family in order to attend
treatment sessions.

30
In addition, the ACS will engage patient in a discussion about their beliefs about
therapy and medication. Beliefs about treatment efficacy are particularly
important to address given our previous finding that beliefs predict treatment
attendance. The goal of the discussion is to correct overly negative or mistaken
beliefs about the therapy process, and give information about the treatment,
thereby increasing the patient’s outcome expectancies. The other goal is to
continue to try to help the patient weigh the balance between the “cost” of
change vs. the “cost” of living with high levels of anxiety, and help tip the balance
in favor of change by highlighting the discrepancy between where the patient is
and where they want to be.
EDUCATION ABOUT TREATMENT
This section is designed to provide patients with sufficient detail about CBT and
medications for anxiety disorders so that they can make an informed treatment
decision. In addition, the information is intended to prepare patients for engaging
in treatment by familiarizing them with the treatment process, correcting
treatment myths, and enhancing patients’ expectations for positive outcomes and
their self-efficacy for being able to complete treatment.
[Present the following information in a discussion format, encouraging the patient
to ask questions throughout, and addressing the negative beliefs that they
endorsed on the Beliefs Questionnaires.]
A) Cognitive Behavioral Therapy
Cognitive Behavioral Therapy provides a set of skills for dealing with
excessive anxiety. These skills are learned during sessions with me and are
practiced between sessions. First, you’ll learn all about anxiety and anxiety
symptoms so that you understand more about what is happening to you, how
your anxiety developed, and what is maintaining it over time Second, skills are
taught for replacing overly negative or anxious thoughts and ruminations (i.e., the
things people “think” to themselves in certain situations) with more realistic
thoughts. This is important because how anxious we feel is closely tied to what
we tell ourselves and what we think about. In addition, CBT teaches ways of
shifting attention onto things that need to get done and away from excessive
worrying. Third, CBT teaches ways of directly facing places, people, or things
that are anxiety-inducing. This builds a sense of control. This is called exposure
therapy, and it is done in a gradual way so that you build confidence with each
step.
Because CBT is a learning process, the positive effects last after the CBT
sessions are over. In fact CBT has been demonstrated to be a very effective
treatment for anxiety disorders in many different studies with many different types
of people. Between 70 and 90% of people who complete CBT make significant
improvements in their lives and are significantly less anxious. It seems that the
best results come from being fully committed to the learning and the exercises –
Comment [s3]: I wonder about
writing this in a more conversational style
so that the ACS might be more likely to
follow it more uniformly? Let me know
what you think and if you agree I’ll revise
a bit more. SSW

31
the more you practice, the better the results. However, it does take effort and
CBT needs to be a priority for it to work. That is, it is not a good choice to do CBT
half-heartedly.
Usually, CBT lasts anywhere from 4 to 12 sessions. In this program, we
will be offering 6 initial sessions of CBT. In most studies, the positive effects start
to appear after about four sessions. This means meeting with me here at the
clinic about once per week, about 45 minutes each time, for up to 6 times. Each
time we would talk a little about how you were feeling. Then, I would show you
the skills and we would practice them together and then you would practice them
on your own. Also, I would give you a workbook that summarizes everything you
are learning with me, and copies of the audiotapes of our sessions (OR ACCESS
VIA COMPUTER OR CD) so that you can refer to the information whenever you
want.
At this point the patient can either view a short video tape segment
demonstrating a therapist talking with a patient about their cognitions or their
behaviors or, as a way of demonstrating the treatment, the ACS can take an
example of a situation that the patient avoids and briefly describe how exposure
therapy would be arranged for that avoidance.
The ACS should then ask the patient if he or she has questions about CBT, its
effectiveness or what is involved in making it work.
B) Medications
Medications decrease panic and anxiety by changing the availability of
neurotransmitters within or between nerve cells. This initial effect initiates many
other effects in the brain as the brain adjusts to these neurotransmitter changes.
This process of adjustment often takes several weeks, which is why medications
usually don’t work immediately. During this adjustment the brain “rebalances”
itself. Therefore medication is not giving your brain something extra it lacks, or
taking away something it has too much of. Rather, it is helping your brain work
more efficiently doing the job it has to do of combating stress. Imagine that the
brain has a stress thermostat that keeps it in balance as different stresses impact
on it, just like a thermostat keeps a room at the same temperature despite
changes in the outside temperature. Anxiety may occur when the set point that
sets the ideal stress level (or temperature) gets moved too high or too low. The
process of rebalancing moves the set point back to the middle so that the brain
can work much like before.
Medications are highly effective for anxiety problems, with many studies
across many different types of people showing that anywhere from 70 to 90% of
those who complete the medication treatment have significant improvements in
their lives and significant reductions in their anxiety. The positive effects usually
begin to appear after four to six weeks. However, medications are not very
effective if they are not taken at the right dose, are not taken in a consistent
manner, or are discontinued too soon. Typically, medications are prescribed for

32
the duration of at least a year. Sometimes relapse can happen once the
medications are withdrawn, but this is much less of a problem if the withdrawal is
done carefully under supervision and if you learn other ways of coping with stress
and anxiety.
If you elect to take medications, I would meet with you weekly for the first
two weeks and then at two to four week intervals after this, depending on how
you are responding to the medication. We might also substitute telephone
sessions for meetings depending on your preference as well as on how much we
need to cover in the sessions, which will depend in large part on how you are
responding. The purpose of the meetings is to make sure you are responding
positively to the medications (i.e. that your symptoms are improving) and that any
side-effects you experience can be eliminated by adjusting the medications.
At this point the ACS asks the patient questions regarding medications and their
previous history with medication such as which ones have been used, whether
they were effective, and the side effects. Side effects are addressed by
describing them as normal bodily adjustments to medications, which are not
dangerous.
SELF EFFICACY AND OUTCOME EXPECTANCIES
At this point the patient rates on 0-8 point scales the degree of positive outcome
expectancy and self-efficacy (their conviction in their own ability to carry out the
treatment) for CBT as well as for medication (see below). Any scores lower than
8 provide the opportunity to ask “Why is the rating not an 8? What contributes to
that lower rating?” Responses will provide an opportunity for the ACS to correct
any misinterpretations or myths. For example, patients may believe that their
long-standing anxiety symptoms are not treatable, that their anxiety represents a
personality trait that cannot be changed, or that because past treatments did not
work, new treatments will not work. The ACS will address these issues in a
realistic fashion. These ratings will be repeated at every ACS session.
Outcome expectancy:
How likely is it that your anxiety can be successfully treated?
0----------1----------2----------3----------4----------5----------6----------7----------8
Not at Possibly 50/50 Very Likely Certainly
All
Self-efficacy expectancy:
How likely is it you can do what is necessary to make anxiety treatment
successful?
0----------1----------2----------3----------4----------5----------6----------7----------8

33
Not at Possibly 50/50 Very Likely Certainly
All
Choice:
The patient will then be asked to make a decision about which treatment they
would prefer or be given more education materials (brochures and videos) to
consider and then return to the ACS with their decision. The patient will be
encouraged to choose one modality initially, although patients strongly
desiring both treatments will be accommodated.
At the end of the visit, the ACS will complete an Initial Visit Worksheet and
consult with the patient’s primary care provider about the initial treatment plan,
ideally on the day of the initial visit but not later than 2 days after the initial visit.
After the conclusion of the session, the ACS will send a handwritten letter to
increase probability of return. Anecdotally these can be extremely helpful in
reducing early dropout. The following is an example.
“Dear Mr. X:
This is just a note to say that I’m glad you came in today. I agree with you that
there are some serious concerns for you to deal with, and I appreciate how
openly you are exploring them. You are already seeing some ways in which you
might make a healthy change, and (your wife seems very caring and willing to
help – if appropriate and an SO has been discussed). I think that together you (if
referring to spouse) or we (if ACS and patient) will be able to find a way through
these problems. I look forward to seeing you again on Tuesday the 24 th at 2:00.
Sincerely, ACS

34
6. COURSE OF TREATMENT-FOCUS ON STEP 1
Overview:
Because patients will enter the study at different stages of treatment, the general
procedure outlined below will not apply to all cases. The following describes the
‘typical’ course for a newly diagnosed patient with one of the four anxiety
disorders, who is not in active treatment at the initial visit. Patients who are
already part-way into Step 1 treatments (i.e., antidepressant medication or CBT)
at the time of the initial visit will usually continue to complete Step 1 unless the
current treatment is poorly tolerated (this will most often apply to medications
rather than CBT, although conceivably a patient may be receiving CBT and not
responding well). Patients who enter after having recently completed what
appears to be good quality step one treatment will be discussed in the team
meeting with the team psychiatrist and may enter at Step 2. The majority of
patients, however, will enter at Step 1.
Pharmacotherapy:
If the patient and the PCP decide to start with medications, the PCP will write a
prescription after consulting the medication algorithm provided to them. The
prescription should occur as close as possible to the initial ACS patient visit; in
some cases that PCP may already have written the prescription when first seeing
and identifying the patient, prior to randomization. After initiating medication
treatment, the ACS will have phone contact with the patient within one week to
make sure the prescription has been filled and the patient is not experiencing any
side effects that might lead to early treatment dropout. A guideline on how to
manage medication side effects is provided in the previous section on steppedcare.
The ACS will then have weekly contact with the patient during the initial acute
treatment phase, and may then decrease to contact every two to four weeks
depending on the patient’s progress. A guideline for routine contact might be
weeks 1, 2, 4, 8, and 12. These contacts can be in person or by telephone as
clinically indicated. Especially for the early contacts, in person visits are generally
recommended. Early contacts will focus on the recognition and management of
early treatment side effects and the possibility of worsening anxiety symptoms.
Regulation of health habits (sleep, diet, exercise, behavioral activity) will also be
recommended to facilitate adjustment to both medication and symptoms. Later
follow-up contacts will focus on adherence to ongoing treatment, progress in
anxiety symptom reduction and continued improvement in health habits.
During each follow-up contact, the ACS will assess the patient’s anxiety and
depression symptoms using a set of rating forms that can be completed by the
patient in 2-3 minutes in the waiting room before a visit and scored by the ACS at
the start of each session. These rating forms are shown below. Review of the

35
rating scales often provides a good opportunity to start a discussion of changes
in the patient’s symptoms. In addition, at the start of each session the ACS will
monitor the patient’s perceived self-efficacy and outcome expectancy for
treatment success in order to address recurring barriers to treatment
involvement. Decisions about changes in treatment, based on these ratings, will
be made with the consulting psychiatrist at regular team meetings.
Overall Anxiety Severity and Impairment Scale (OASIS)
The following items ask about anxiety and fear. For each item, circle the number for the answer that best
describes your experience over the past week.
1. In the past week, how often have you felt anxious?
0 = No anxiety in the past week.
1 = Infrequent anxiety. Felt anxious a few times.
2 = Occasional anxiety. Felt anxious as much of the time as not. It was hard to relax.
3 = Frequent anxiety. Felt anxious most of the time. It was very difficult to relax.
4 = Constant anxiety. Felt anxious all of the time and never really relaxed.
2. In the past week, when you have felt anxious, how intense or severe was your anxiety?
0 = Little or None: Anxiety was absent or barely noticeable.
1 = Mild: Anxiety was at a low level. It was possible to relax when I tried. Physical symptoms were
only slightly uncomfortable.
2 = Moderate: Anxiety was distressing at times. It was hard to relax or concentrate, but I could do it
if I tried. Physical symptoms were uncomfortable.
3 = Severe: Anxiety was intense much of the time. It was very difficult to relax or focus on anything
else. Physical symptoms were extremely uncomfortable.
4 = Extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were
unbearable.
3. In the past week, how often did you avoid situations, places, objects, or activities because of
anxiety or fear?
0 = None: I do not avoid places, situations, activities, or things because of fear.
1 = Infrequent: I avoid something once in a while, but will usually face the situation or confront the
object. My lifestyle is not affected.
2 = Occasional: I have some fear of certain situations, places, or objects, but it is still manageable. My
lifestyle has only changed in minor ways. I always or almost always avoid the things I fear when
I’m alone, but can handle them if someone comes with me.
3 = Frequent: I have considerable fear and really try to avoid the things that frighten me. I have made
significant changes in my life style to avoid the object, situation, activity, or place.
4 = All the Time: Avoiding objects, situations, activities, or places has taken over my life. My lifestyle
has been extensively affected and I no longer do things that I used to enjoy.
4. In the past week, how much did your anxiety interfere with your ability to do the things you needed to
do at work, at school, or at home?
0 = None: No interference at work/home/school from anxiety
1 = Mild: My anxiety has caused some interference at work/home/school. Things are more difficult,
but everything that needs to be done is still getting done.
2 = Moderate: My anxiety definitely interferes with tasks. Most things are still getting done, but few
things are being done as well as in the past.

36
3 = Severe: My anxiety has really changed my ability to get things done. Some tasks are still being
done, but many things are not. My performance has definitely suffered.
4 = Extreme: My anxiety has become incapacitating. I am unable to complete tasks and have had to
leave school, have quit or been fired from my job, or have been unable to complete tasks at home
and have faced consequences like bill collectors, eviction, etc.
5. In the past week, how much has anxiety interfered with your social life and relationships?
0 = None: My anxiety doesn’t affect my relationships.
1 = Mild: My anxiety slightly interferes with my relationships. Some of my friendships and other
relationships have suffered, but, overall, my social life is still fulfilling
2 = Moderate: I have experienced some interference with my social life, but I still have a few close
relationships. I don’t spend as much time with others as in the past, but I still socialize
sometimes.
3 = Severe: My friendships and other relationships have suffered a lot because of anxiety. I do not
enjoy social activities. I socialize very little.
4 = Extreme: My anxiety has completely disrupted my social activities. All of my relationships
have suffered or ended. My family life is extremely strained.
PHQ 3
Over the last two weeks, how often have you been bothered by any of the following problems?
Not at all Several days More than half the days Nearly every day
0 1 2 3
1. Little interest or pleasure in doing things
2. Feeling down, depressed, or hopeless
3. Feeling tired or having little energy
Outcome expectancy:
How likely is it that your anxiety can be successfully treated?
0----------1----------2----------3----------4----------5----------6----------7----------8
Not at Possibly 50/50 Very Likely Certainly
All
Self-efficacy expectancy:
How likely is it you will be able to do what is necessary to make anxiety treatment successful?
0----------1----------2----------3----------4----------5----------6----------7----------8
Not at Possibly 50/50 Very Likely Certainly
All
The ACS will document all follow-up contacts on the Web-based systems and a
printout of this document can be shared with the PCP, and placed in the patient’s
primary care chart at the discretion of the PCP. Patients who participate in the
study will have provided consent for sharing this health-related information with
their PCP.

37
In most cases, the 2-week follow-up contact will be in-person with the ACS, but
subsequent follow-ups can be conducted by telephone if the ACS feels this is
clinically reasonable and the patient prefers this.
CBT:
If the patient and the PCP decide to start with a trial of CBT, the ACS will
schedule the patient for his or her initial session at the primary care clinic.
Patients started in CBT as the first line of treatment will be seen for up to 6
sessions by the ACS in the clinic (see CBT manual). These sessions will usually
be scheduled weekly but not less frequently than every other week. As with
pharmacotherapy, each session will begin with an assessment of (1) patient
symptom status using the symptom ratings and (2) patient self-efficacy and
outcome efficacy to assess barriers to treatment engagement. The content of
the CBT sessions is outlined in detail in the CBT treatment manual.
General Treatment Issues:
The ACS consults with the patient’s PCP and the study psychiatrist or
psychologist as needed if the patient is experiencing symptoms or problems not
easily addressed by the ACS. The patient may require additional PCP visits if
such problems are not easily resolved by the ACS. Many patients will have a
visit with their PCP at week 4. If the patient is doing well and this visit can be
easily accomplished by the ACS, the patient and PCP may decide to skip this
visit. The ACS will inform the PCP (using the PCP’s preferred method of
communication, e.g., e-mail, fax, letter) of the patient’s progress and to prompt
the PCP to reinforce certain key steps in the patient’s treatment during the
primary care visit.
If at any time patient attendance or interest wanes, as indicated by lack of
attendance, or lack of completion of assignments in the case of CBT, or lowered
expectancy ratings on the scales of self-efficacy and outcome expectancy, the
reasons for the decreased engagement will be addressed. Sometimes this may
require a phone call to the patient who is not attending sessions expressly to
brainstorm perceived barriers to attending treatment. The ACS will re-assess for:
New or ongoing barriers to treatment (e.g., scheduling issues, family
issues)
Negative reactions to the treatment (e.g., side effects,
unpleasant emotions, disparities between initial expectations and
process of treatment thus far) and consideration of ways of managing
these issues
Negative outcome expectancies (e.g., judging that treatment will not
work) and consideration of the evidence
Negative self-efficacy (e.g., judging that they cannot carry out the
treatment) and consideration of ways of building self-efficacy through
designing smaller tasks to be accomplished

38
In each case, the ACS and patient will problem solve so that treatment
engagement is renewed.
The ACS will immediately contact and consult with the PCP (and the team
psychiatrist as needed) if the patient develops any of the following serious
problems:
acute suicidal symptoms
psychotic symptoms
manic symptoms
suspected alcohol or drug abuse or dependence (including prescription
medications)
side-effects that are especially bothersome to the patient and are felt to
compromise the patient’s health and/or their continuation in treatment.
In order not to unduly overburden the PCP with side-effect concerns,
the ACS may first consult with the study psychiatrist to see if an
immediate call to the PCP is warranted.
An outline of a general approach to the evaluation and treatment of
psychiatric emergencies such as acute suicidality can be found in the
appendix of this manual. Each clinical team will adapt this approach to
their clinic needs and operations. This plan starts with an evaluation by the
ACS or the study psychiatrist whenever possible but must also be integrated with
the response mechanisms for psychiatric emergencies generally available in
each system of care. It is especially important to assure coverage during times
when the ACS or study psychiatrist is not immediately available (although it
should be noted that a study psychiatrist will always be “on-call” by pager), and to
ensure that treatment plans for psychiatric emergencies involve the regular
treatment team whenever possible.
Assessment of initial treatment course – (usually week 12)
All patients will have a visit with the ACS and primary care provider about 12
weeks after enrollment. This assessment can occur a bit earlier IF the patient
entered treatment mid-way through step 1 (i.e., patients enters and has already
been on an adequate dose of an antidepressant for 4 weeks). The purpose of
this contact is to formally assess response to the initial course of treatment. The
OASIS and PHQ-3 will be used to assess status and change. Patients who
achieve remission, defined as a total score of 8 or less on the OASIS and a score
of 5 or less on the PHQ-3 will go on to maintenance treatment.
Patients who have not achieved remission to the first line of treatment will be
discussed in the weekly team meeting and will likely be seen for a consultation
by the study psychiatrist. After this consultation, the ACS will decide with the
patient’s PCP and the patient on subsequent treatment following the guidelines
provided by the stepped care model above. These patients will ordinarily enter

39
the next step, unless the patient expresses good satisfaction with his/her level of
symptom control and functioning, and expresses a desire to maintain the current
treatment. In these circumstances (obviously this will involve only those patients
who have clearly had SOME response to treatment indicated by measurable
reduction in ratings on the OASIS items and the in PHQ-3 scores), the patient will
be considered to have had a very good to excellent response and will enter
maintenance treatment.
MAINTENANCE TREATMENT
Patients who have had a very good to excellent treatment response will meet
with the ACS to complete a Relapse Prevention Plan (these plans can be found
in the WEB-based system). They will be followed by the ACS with monthly
telephone calls, and will be encouraged to call their PCP or the ACS if symptoms
of anxiety return or if they have questions regarding treatment. All patients are
encouraged to stay on continuation treatment (either full dose of the
antidepressant that led to clinical response or monthly maintenance CBT) for the
duration of the year-long intervention phase. Patients at high risk for relapse will
be identified by enumerating the presence of known risk factors, which include:
multiple anxiety disorders, co-morbid depression, co-morbid personality disorder,
ongoing chronic psychosocial stress or medical illness or failure to respond to
first step treatment. Those with the presence of one or more of these are
encouraged to continue maintenance treatments for at least 2 years. Patients
showing signs of recurrence or relapse during this follow-up period will be
discussed in the clinical team meeting and may be scheduled for additional
follow-up visits with the PCP or the ACS as clinically indicated.
Patients entering the study on active treatments (i.e., patients who have recently
been started on an antidepressant) may not follow this exact timeline. They will
also complete the initial assessment and treatment planning session with the
ACS, and they will be closely followed by the ACS (i.e., weekly phone or in
person contacts as needed) until they are in remission from the anxiety
symptoms. The timing of other follow-up contacts with the ACS, the PCP, or the
study psychiatrist may vary depending on the patient’s progress in treatment.
For example, a patient entering the study who appears to have failed a good trial
of a first or second line medication treatment in primary care, and is uninterested
in pursuing CBT, may have a psychiatric consultation earlier in the course of
treatment (i.e., in weeks 1-2).
Termination
The ACS will follow each intervention patient for one year. At the end of the oneyear
follow-up period, the ACS will meet with the patient and PCP to transition
the care of the patient back to the PCP. At this point, the treatment team may
make additional recommendations for ongoing treatment and provide referrals to
other resources that may be helpful in the patient’s ongoing treatment.

Termination can evoke feelings of sadness, fear, or uncertainty in patients and
providers. A clear termination, however, can be an essential phase of the
therepeutic relationship. Termination signals that the study goals have been
reached, but more importantly, offers the opportunity to review the improvements
a patient has made, to identify what has and has not helped, and finally to
discuss future goals and plans for achieving them. Arrangements for transitions
are reviewed, and any feelings or concerns related to termination can be
addressed. An ACS who anticipates difficulties with termination should discuss
these with the patient’s PCP and the treatment team in order to prevent negative
outcomes for either the patient or the ACS.
40

41
7. PSYCHOPHARMACOLOGY STEPPED CARE APPROACH
Initial Treatment Choice: Medication
For those choosing pharmacotherapy, selection of initial medication will be the
first and most important task. Medication selection guidelines are based on the
premise that, for pharmacologic treatment purposes, there are more similarities
than differences among the four anxiety disorders (PD, GAD, SAD, and PTSD).
For example, based on randomized controlled trials (RCTs), selective serotonin
reuptake inhibitors (SSRIs) and venlafaxine extended-release are efficacious for
all four disorders; benzodiazepines are efficacious for Panic Disorder, GAD and
SAD (but probably not for PTSD, though rigorous RCTs are lacking).
Selection of medication depends on whether patients have received prior
pharmacotherapy for the treatment of a mood and anxiety disorder. An SSRI is
the treatment of choice for patients who have never received prior
pharmacotherapy (and do not have a history strongly suggestive of bipolar
disorder). In addition to treating any of the four anxiety disorders, SSRIs will both
treat the frequent presence of comorbid MDD and lower the risk of future MDD
episodes. Exceptions would be a history of serious adverse events
(including allergic reactions) from an SSRI, or failure to respond to what is
judged to be two adequate trials of SSRIs, in which case consultation with
the psychiatrist is encouraged before a starting medication is chosen.
For those with prior medication treatment histories, the particular SSRI that
proved beneficial in the past would usually be the one to start with. Cost may
also enter into the decision: Given that several of the SSRIs are now available in
generic form, consideration should be given to using them preferentially.
Similarly, formulary restrictions may guide SSRI use in some healthcare systems.
In patients with prior response to benzodiazepines, a trial of an SSRI is still
generally recommended (unless there has been failure to respond to two or more
SSRIs, or a history of intolerance to two or more SSRIs). Even though some
SSRIs have FDA approval for particular anxiety disorders, there is no evidence
that one SSRI is better than any of the others in the treatment of the four anxiety
disorders being treated in CALM. Furthermore, although there are subtle group
differences in side-effect profiles among medications (which can manifest as
much larger tolerability differences for individual patients), there is no evidence
that a particular SSRI should have a preferential position in the treatment of
these disorders. Accordingly, as noted above, unless there are compelling
reasons to do otherwise (e.g., history of good – or poor – response to a particular
SSRI in the past), formulary (cost) should be the driving consideration in
selection of initial SSRI.

42
Fluoxetine
(Prozac and
generic)
Paroxetine
(Paxil and
generic)
(or Paxil-CR)
Sertraline
(Zoloft)
Citalopram
(Celexa and
generic)
Escitalopram
(Lexapro)
ANXIOLYTIC
EFFICACY*
Panic**, PTSD*
Panic**, GAD**,
SAD**, PTSD**
Panic**, GAD*,
SAD**, PTSD**
Panic*
Panic*, GAD**,
SAD*
SSRI ANTIDEPRESSANT OPTIONS
ADVANTAGES
Generic available
Long 1/2 life
(No withdrawal)
Generic available. Most
extensively studied
across these anxiety
disorders
Least stimulating
No P450 3A4 effects
Well-studied across
these 4 anxiety
disorders
Least P4502D6 effects
Minimal P4503A4 effects
Intermediate 1/2 life
(Less withdrawal)
Generic available. No
P450 effects
No P450 effects
DISADVANTAGES
Most stimulating
Longer 1/2 life
Most sedating. Shorter ½ life
and worse withdrawal
Most diarrhea
*RCTs but no FDA-approved indication
**FDA-approved indication as of December, 2005
If a patient has had a definite prior response to a non-SSRI antidepressant and
the patient prefers, this antidepressant may be used, regardless of whether it is a
dual-reuptake inhibitor (SNRI), mirtazapine, or TCA (unless the patient has SAD,
which is not thought to be TCA-responsive). If the patient has had non-response
or side-effects to two prior SSRIs, choose between an SNRI (e.g., venlafaxine
XR or, possibly, duloxetine [though, at the time of this writing, the utility of this
particular SNRI in the treatment of anxiety disorders is unknown] or a GABAergic
strategy (benzodiazepines or gabapentin) unless the patient has PTSD,
which has not been shown to be GABA-responsive, or major depression. Some
of these strategies will resemble those used in later steps (2 and 3) of the
treatment protocol (see below). In general, selection among antidepressants
should be based on the patient’s history of medication side-effects, if available.
The side effect table in the next section (titration of initial treatment) can be used
as a guide. For example, in the patient with severe insomnia, one might select a

43
relatively more sedating SSRI such as paroxetine. For the patient with prominent
GI side-effects, one might avoid sertraline to begin with. However, as noted
elsewhere in this manual, response and side-effects are often idiosyncratic.
Therefore, unless particular side-effects are anticipated on the basis of the
patient’s prior experience with SSRIs or SNRIs, cost (and/or formulary)
considerations should generally drive antidepressant selection.
OTHER NON-SSRI ANTIDEPRESSANT OPTIONS
ANXIOLYTIC
EFFICACY*
Panic**, GAD**,
SAD**, PTSD
ADVANTAGES
DISADVANTAGES
Venlafaxine ER
(Effexor XR)
No P450 effects
Short ½ life
Withdrawal with missed dose
or sudden discontinuation
Increased BP at >225 mg
Mirtazapine
(Remeron)
No controlled studies
in anxiety disorders
Rare open reports
Sedation
Oversedation
Increased appetite
and weight gain
Rare agranulocytosis
Duloxetine
(Cymbalta)
No controlled studies
in anxiety disorders
Rare open reports
Unknown
Nausea
Clomipramine
Far fewer controlled
trials, but some
evidence in Panic
GAD, PTSD
Sedation
Can take at bedtime
Very sedating
Weight gain common
Low therapeutic index
*RCTs but no FDA-approved indication
**FDA-approved indication as of December, 2005
A final consideration involves the management of concomitant medication that
the patient may be taking that will not be a first line treatment choice. Most often
this will involve use of either benzodiazepines or low dose, sedating TCAs. For
benzodiazepines, if the patient is on a regular schedule, the PCP should continue
them for at least the first three months of the study so that benzodiazepine
withdrawal symptoms do not complicate or interfere with anti-anxiety response to
antidepressants. The benzodiazepines should be prescribed using a pharmacokinetically
appropriate schedule so as to minimize daily withdrawal or inter-dose
anxiety. If, however, they are only being taken on an as-needed basis (four or
fewer times a week) the PCP and ACS will attempt to help the patient minimize
use and attempt to gradually stop use during the first months of the study.

44
In the case of regular use of low dose, sedating antidepressants, such as
amitriptyline or trazodone, these may be continued at low bedtime doses for the
first several months of the study or, if needed, for the duration, in order not to
exacerbate sleep disturbance.
Titration of Initial Medication Treatment:
SSRIs should be started at low doses typically recommended for anxiety and
titrated to a therapeutic dose over a period of 4-6 weeks. Initial response to
antidepressant medications usually occurs within 4-6 weeks. If there is no
response after 4-6 weeks to an antidepressant at a therapeutic dose, but the
medication is well-tolerated, the dose may be titrated up to the maximum dose
for another 6 weeks. However, some patients find it very discouraging to take a
medicine with no obvious benefit for this length of time. If the ACS, in discussion
with the patient, feels that the therapeutic relationship (and adherence) is likely to
suffer, a switch (usually within class to another SSRI) may be considered for
patients with no response at 4-6 weeks. Another reason to switch before the end
of Step 1 is if the initial antidepressant is poorly tolerated. In that case, the
recommendation would be to switch within class (e.g., one SSRI to a different
SSRI). If there is a partial response by weeks 4-6, a full trial (10-12 weeks) of the
antidepressant at a higher therapeutic dose is recommended. The table below
depicts typical titration schedule guidelines.
Medication Begin Week
1
Week
2
Week
3
Week
4
Top Doses
Fluoxetine
Paroxetine*
Sertraline
Citalopram
Escitalopram
Venlafaxine ER
Duloxetine
Nortriptyline
5 mg
QAM
10 mg
QAM or
QHS
25 mg
QAM
10 mg
QAM
5 mg
QAM
37.5 mg
QAM
20 mg
QHS
25 mg
QHS
10 mg 20 mg 20 mg 30 mg 40 mg
20 mg 20 mg 20 mg 30 mg 50 mg
50 mg 50 mg 50 mg 100 mg 200 mg
20 mg 20 mg 20 mg 30 mg 50 mg
10 mg
QAM
75 mg
QAM
20 mg
BID
50 mg
QHS
10 mg
QAM
75 mg
QAM
20 mg
BID
75 mg
QHS
10 mg
QAM
150 mg
QAM
30 MG
BID
75 mg
QHS
10 mg
QAM
225 mg
QAM
30 MG
BID
100 mg
QHS
20 mg QAM
225 mg
QAM
30 MG
BID
125 mg
QHS
* Paroxetine-CR may also be considered (in which case equivalent dosing is
from 12.5mg/d to 62.5 mg/d), though, in most instances, formulary constraints
will favor immediate release paroxetine

45
During this 3 month time period, adjunctive medication to help with sleep
problems is allowed and would include trazodone (an inexpensive generic),
zolpidem (Ambien), zaleplon (Sonata), eszopiclone (Lunesta) or in the case of
intractable PTSD nightmares, prazosin. If, after 2-4 weeks, patients cannot
tolerate a particular treatment (i.e., intolerable side effects even with careful
titration and clinical management), consider restarting Step 1 by switching to an
alternative antidepressant or, if the side effects have now made the patient
averse to continuing further medication trials, CBT. The ACS in this case will
make a determination before the originally scheduled 12 week time-point, a
necessary alteration in order to provide appropriately tailored treatment for the
individual. Management of the side effect may include, beyond routine dose
reduction with an attempt to preserve efficacy, a substitution of another
antidepressant on the list with a more benign side-effect profile for that individual.
Strategies for managing common side effects of antidepressants are outlined
below.
Adverse Effect Fluoxetine Sertraline Paroxetine Citalopram or Nortriptyline
Escitalopram
Headache - - -
Agitation/
Anxiety
- -
Tremor
Insomnia -
Drowsiness
Fatigue -
Confusion - - - - -
Dizziness - -
Anti-cholinergic* - - -
Sweating - - -
Weight Gain
GI - -
Sexual
Venlafaxine**
Increases occurrence
Decreases occurrence
* “Anticholinergic” side-effects include dry
mouth, constipation, urinary hesitancy or
retention, blurred vision
** Can increase blood pressure; must be
monitored

46
MANAGING COMMON SRI SIDE-EFFECTS IN THE
TREATMENT OF ANXIETY DISORDERS
Adapted from Preskorn, J Clin Psychiatry 1995; 56 (suppl6)
Problem
Suggested Management
Insomnia 1. Move dosing to early part of day
2. Add trazodone 50-100 mg at bedtime
3. In men concerned about priapism, use zolpidem 10 mg,
zaleplon 10 mg, or esczopiclone 2 mg, if there are no
concerns regarding abuse
5 Add doxepin or amitriptyline 25-50 mg at bedtime
6 Switch antidepressant (e.g., to paroxetine or citalopram)
Nausea/Diarrhea 1. Take with food
2. Encourage patient persistence (should reduce with time)
3. Reduce dose for 4-7 days, then reintroduce higher dose
4. Switch antidepressant (usually to another SSRI)
5. Add H 2 -blocker or Proton Pump Inhibitor (PPI) for
dyspepsia; Lomotil, acidophilous for diarrhea
Sedation 1. Move dosing to bedtime
2. Encourage patient persistence (may reduce with time)
3. Switch antidepressant (e.g., to fluoxetine or sertraline)
Delayed Ejaculation/ 1. Add sildenafil [Viagra] 50-100 mg or other comparable Rx
Anorgasmia 2. Add bupropion 75 mg QAM – BID
3. Switch to mirtazapine
Assessing Treatment Response:
An adequate trial of Step 1 treatment means that patients have completed an 8-
12 week antidepressant (usually SSRI) trial at a sufficient dose (see above for
dosing guidelines) or a trial of up to 6 sessions of CBT. The OASIS and PHQ-3
will be used by the ACS to determine response. Patients who have achieved
remission following step 1 treatment should proceed to relapse prevention
planning and maintenance treatment (see below).
Step 2
Stage 1 Medication Treatment Failures. Generally, these recommendations have
been less well-established in controlled trials. One failed SSRI trial should
prompt consideration of a second SSRI. Patients who have “failed” (i.e., either
due to poor response or poor tolerability) adequate trials of two first-line
antidepressants at step 1 (usually one or more SSRIs) should be considered for
a trial of a first-line antidepressant from a different class. The choice of the
second agent may vary depending on the clinical circumstances (psychiatric

47
consultation will be helpful with this decision). If the first trial was with an SSRI or
if the patient has a comorbid depression, a dual reuptake inhibitor (also known as
a serotonin-norepinephrine reuptake inhibitor [SNRI]) such as venlafaxine
extended-release is recommended for a 2 nd trial. If there is absolutely no
evidence of depression and somatic symptoms of anxiety are particularly
prominent, a primary GABA-ergic agent such as a benzodiazepine or another
agent such as gabapentin or pregabalin would also be an option. Patients may
also be considered for a trial of another ‘newer’ antidepressant such as
mirtazapine or duloxetine at a therapeutic dose, although there is minimal
controlled data supporting their use in anxiety disorders. Bupropion is not
recommended for primary treatment of anxiety disorders, due to a lack of
evidence as to its efficacy for these conditions.
At this stage, there needs to be careful review of the common indications or
considerations for the use of benzodiazepines in anxious patients.
Benzodiazepines are contraindicated for patients with substance abuse
problems and usually prior substance abuse history or as monotherapy in
patients with significant concomitant depression. Benzodiazepines are
indicated if there is a history of non-response to two different antidepressants
classes or if there is severe medical illness or other problems providing
contraindications to using other antidepressants. The other common reason for
benzodiazepine prescription (severe symptoms and disability requiring
immediate attention early in the course of care) can be offset by the availability of
the ACS in this protocol (for patients assigned to the intervention group) who will
have regular weekly meetings for the first few weeks with the patient and provide
support and encouragement, which is often an adequate substitute for the use of
benzodiazepines in the primary care setting. However, some patients may
require supplemental benzodiazepines in the first few weeks if symptoms are too
severe.
Benzodiazepines may also be preferred for the bipolar II patient since some
antidepressants may precipitate mania or increased cyclicity of mood. Preferred
medications are alprazolam 2.0 – 6.0 mg daily (usually split into TID or QID
dosage) lorazepam 1.0-3.0 mg daily (usually split into TID or QID dosage) or
clonazepam 1.0 – 4.0 mg daily (usually split into BID dosage). The longer-acting
benzodiazepines (e.g. clonazepam or extended release alprazolam) are
preferable to minimize interdose anxiety.
Finally, when benzodiazepines are being considered but (relative)
contraindications are evident (e.g., personal history of alcohol abuse now in
remission), some consideration should be given to using alternatives such as
gabapentin [Neurontin] or pregabalin [Lyrica]. Gabapentin is nearly devoid of risk
of drug-drug interactions, making it a good choice for patients with multiple
comorbid medical illnesses and medications. It must be given on a TID schedule
(total daily dose 900-3600) and will usually be much more costly than
benzodiazepines. The role (and dosing) for pregabalin in treatment of anxiety

48
disorders outside of GAD or SAD, and particularly as an adjunct to
antidepressant treatment, is currently unclear. It should be remembered that
benzodiazepines have a long history of use, and strong evidence of
demonstrated efficacy. Unless there are contraindications to their use, they
should generally be tried prior to using the newer, more expensive medications
like gabapentin or pregabalin.
Stage 1 Medication Partial-Responders. It will be assumed that all medication
partial-responders have had their antidepressant dose pushed to the maximum
dose and are still non-responsive. In general, augmentation strategies are less
preferable in primary care because they require closer clinical monitoring, more
complex drug regimens, and often greater expense to the patient. There are,
however, times when a patient has had a partial response to an initial
antidepressant agent and augmentation with another medication is clinically
indicated. The team psychiatrist will have seen the patient and can help in
making the appropriate decision and providing guidance. The two general
strategies to be pursued are: combination of an SSRI with a GABA-ergic agent
(e.g. benzodiazepine or gabapentin [or pregabalin]); and combination of an SSRI
and a noradrenergic antidepressant (e.g., nortriptyline or desipramine). While this
latter strategy is unproven in anxiety disorders, it has good support in the
treatment of depression. When SSRIs are combined with TCAs, serum levels of
the TCA should be checked to avoid toxicity resulting from drug interactions (see
appendix C). In some circumstances of combined depressive and anxiety
symptoms (e.g., where sexual side-effects hamper compliance to other
medications), a combination of bupropion and a benzodiazepine may also be
considered. Combinations of SSRIs or venlafaxine with mirtazapine may also be
considered.
Additional strategies such as augmentation with the atypical anti-psychotics
olanzapine, risperidone, quetiapine, or aripiprazole (see below) may be
considered in later stages after further consultation with the team psychiatrist.
Steps 3 and 4:
Patients who have not had a full response at Step 2 should be discussed in the
weekly team meeting and strongly considered for an additional psychiatric
consultation that could last more than one session, in the primary care clinic (see
below). At this step the psychiatrist may suggest and initiate a number of
treatments in consultation with the ACS and the patient’s PCP. There is no
evidence base to guide care at this juncture. Rather, the choice of treatment at
this step depends on the clinical situation, the resources available, and the
patient’s treatment preferences.
Recommended treatment strategies for Step 3 include:

49
nd
rd
1. A trial of a 2 or 3 type of antidepressant (TCAs could be considered;
MAOIs may need to be considered especially in cases of refractory
PD and SAD)
2. Combination of antidepressant and benzodiazepine (or benzodiazepine
alternative, as described above), if this has not already been tried at an
earlier step.
3. Other augmentation strategies such as augmentation of either SSRIs or
venlafaxine ER with the atypical anti-psychotics olanzapine, risperidone,
quetiapine, or aripiprazole. This may be especially worthwhile if the patient
has had a partial response to treatment at Step 2. It should be noted that
although there is growing evidence that adding an atypical antipsychotic
may be a useful strategy for refractory depression, the evidence base in
anxiety disorders is considerably less well-developed.

50
8. PSYCHIATRIC EVALUATION FOR PERSISTENT ANXIETY
Psychiatric evaluations for persistent anxiety have two major objectives:
1. To clarify the diagnosis including the specific psychiatric disorder(s)
and comorbid medical problem(s) or medication(s) that must be
considered in developing a treatment plan;
2. To develop a treatment plan for Step 2 or 3 and, when indicated, to
initiate treatment in cooperation with the ACS and the patient’s
PCP.
The following table lists a number of factors to explore during the initial
consultation. The results of such consultations should be documented by the
team psychiatrist using the web-based data entry form. Also, psychiatric
evaluation is conducted with the patient after a full enquiry with the ACS
regarding issues of perceived barriers to treatment, disparities between the
patient’s treatment expectations and process, as well as their outcome and
efficacy expectations over the course of treatment thus far.
1. Evaluate for other psychiatric disorders
bipolar disorder
other anxiety disorders not already recognized
obsessive compulsive disorder
psychotic disorder or psychosis
somatization or somatoform disorders
alcohol or substance abuse (includes prescription drugs)
cognitive impairment/dementia
personality disorders and maladaptive coping mechanisms
2. Consider medical disorders or medications that may contribute
to anxiety
substance use problems
surreptitious benzodiazepine use
obstructive sleep apnea
complex partial epilepsy
surreptitious opiate use
cardiopulmonary conditions (e.g., asthma; CHF)
thyroid disease, either hypo or hyper
caffeinism
OTC cold preparations
herbal preparations (e.g., weight loss or “energy-enhancing”
compounds)
steroids
bronchodilators
anemia

51
3. Consider anxiogenic health habits
sleep deprivation
sedentary lifestyle (lack of exercise)
social use of alcohol or caffeine
smoking
4. Explore prior treatment history
adequacy of treatments attempted
attitudes toward treatments and providers
successes
failures
relevant treatment history in close relatives
5. Address problems with adherence in consideration of the
barriers already identified by the ACS
different explanatory model—patient does not feel understood
cultural barriers
secondary gain
life stressors (care giving, unresolved grief, financial)
instrumental barriers (finances, transportation, time)
cognitive impairment
side effects
patient demoralization
6. Address psychosocial issues in greater detail (e.g. history of
abuse)
The web-based ‘record’ of psychiatric consultation covers most of the factors to
be considered during an evaluation and leaves room to record a diagnostic
formulation and treatment recommendations

52
9. DOCUMENTING AND TRACKING CLINICAL ENCOUNTERS
USING THE WEB-BASED CLINICAL INFORMATION SYSTEM
The Anxiety Clinical Specialist (ACS) will use a web-based clinical information
system to track each patient’s progress throughout the one-year intervention
period. He or she will use a personal computer (a stand-alone PC or a laptop)
and a standard web browser (Microsoft Internet Explorer version 5.0 or higher) to
log on to a secure server at the coordinating center and enter a unique login ID
and password. The ACS will complete a new enrollment form for each
intervention patient and will then enter an initial assessment, follow-up
assessments, treatment plans, or a relapse prevention plan as treatment
proceeds. Samples of these data entry forms are being developed.
Data entry can occur ‘on line’ during a patient session, after a patient session, or
at the end of the day. If data are not entered in ‘real time’, the ACS should make
notes using a paper copy of the relevant form and should enter the data as soon
as possible (usually the same day). Blank copies of the data acquisition forms
can be printed off the password protected section for investigators on the main
study web site. During the data entry, the ACS will have to enter the patient’s
study ID number and initials, as the database will store information entered by
these identifiers. After completion of a data entry form, the server will ‘validate’
the form, perform ‘range checks’ on certain data entry fields and will prompt the
ACS for corrections if data entered are not consistent with ranges specified for
particular ‘fields’. This will allow for better data quality and more uniformity in the
treatment intervention. After each contact form is completed and checked, the
ACS will submit the form to the server, where it will be stored in a database. The
server will then format the information, which should be printed ‘on site’. A copy
of each form should be placed in the patient’s study record, and additional copies
can be shared with the patient and the PCP as clinically appropriate. A copy of
each note may also be placed in the patient’s regular clinic record at the
discretion of the PCP. All completed forms can be accessed on the web site and
updated or modified at anytime.
The ACS or other site investigators can also log on to the secure server and
request an updated caseload tracking report of all intervention patients that will
show if specific intervention activities have been completed or not or a progress
report on an individual patient.
STANDARDIZATION OF INTERVENTION
The clinical database will be searched regularly at the UW site, which will be
coordinating the intervention implementation, to identify potential clinical
problems or problems in adherence to the intervention protocol. Examples might
include cases where patients don’t appear to be on active treatments (i.e.,
antidepressants at adequate doses or CBT), or where patients don’t seem to

53
have follow-up contacts as specified in the intervention protocol. The program
will generate prompts to identify potential problems to each ACS each time he or
she logs on to the system.
The database at the coordinating center will also be used to track the
implementation of the intervention at all study clinics, and it is thus very important
that all clinical contacts (both in person and telephone) are recorded as
completely as possible.
ASSURING PRIVACY AND CONFIDENTIALITY OF PATIENT INFORMATION
Patient information gathered for this study is sensitive and must be regarded as
highly confidential. Even the fact that the patient is enrolled in the study should
be viewed as private and confidential. All study materials that identify patients by
name and/or number must be kept in locked files or secure locations when not in
use. Only the ACS and the principal investigator at each site should have access
to documents that link patient study ID numbers to their other identifying
information (i.e., name, address, telephone numbers, or medical record
numbers). It is possible that primary care providers will choose to put forms into
patients’ regular medical records. This decision is made at the discretion of the
patient and his/her primary care provider.

54
10. PCP’S GUIDE FOR ANXIETY MANAGEMENT
The following guidelines are to be used by the PCP in their day to day
management of anxious patients
Seven Key Challenges in Managing Anxiety
1. Make a diagnosis and include all diagnoses to start.
2. Educate and recruit the patient as a partner in treatment.
3. Start with a single treatment modality and match to patient
preferences.
4. Use correct medication doses and/or work in collaboration with
skilled practitioners of evidence-based (i.e., CBT) psychotherapy
5. Treat long enough initially. Patients often take 10-12 weeks to
respond.
6. Follow outcomes and adjust treatment as needed. Consider
consultation if patient is not improving.
7. Treat long enough to prevent relapses (6-12 months) and know the
signs of high risk for relapse.
Diagnosing Anxiety in Primary Care
SIGNS AND SYMPTOMS OF ANXIETY
Cognitive symptoms: worry, rumination, anxious preoccupation,
cognitive distortions such as catastrophization (imagining the worst
outcome), overestimating the risk of something bad happening,
overgeneralization, overpersonalization
Physiologic symptoms: palpitations, shortness of breath, dizziness,
nausea, diarrhea, hot and cold flashes, sweating, numbness and
tingling, derealization, depersonalization, muscle tension, insomnia
Behavioral signs: avoidance of various activities, hypervigilance

55
Conditions Characterized by Anxious Symptoms
PANIC DISORDER (PD)
Recurrent panic attacks, at least some spontaneous (panic attacks are sudden
bursts of anxiety accompanied by at least several cardiorespiratory,
gastrointestinal, autonomic or otoneurological symptoms)
Persistent fear of future attacks, or change in behavior because of attacks (e.g.
going to emergency room, asking for medical tests), or phobic avoidance (e.g.
restricting activity, driving, going to stores etc) because of attacks
GENERALIZED ANXIETY DISORDER (GAD)
Unrealistic, hard to control, persistent worry about numerous life situations, for at
least 6 months, 50% of the time
At least 3 of 6 symptoms (insomnia, poor concentration, restlessness, fatigue,
irritability, muscle tension)
SOCIAL ANXIETY DISORDER (SAD)
Marked or persistent fear of social or performance situations in which one is
exposed to unfamiliar people or possible scrutiny by others and fears
embarrassment or humiliation
Exposure to these situations provokes anxiety, which may take the form of panic
attacks
The situations are then avoided or endured with dread
POST TRAUMATIC STRESS DISORDER (PTSD)
Exposure to a life-threatening or personal integrity-threatening traumatic event
Reexperiencing of the event by flashbacks, nightmares, recurrent recollections,
etc.
Persistent avoidance of reminders of the trauma and numbing of general
responsiveness (i.e. detached, estranged, no future orientation)
Persistent symptoms of arousal (insomnia, irritability, hypervigilance, startle)
OBSESSIVE COMPULSIVE DISORDER (OCD)
Recurrent obsessions and compulsions that are time-consuming and interfering
Not covered by CALM; refer to regular mental health care resources

56
Talking to Patients About Anxiety
A biopsychosocial model that emphasizes the hard to control factors of innate
genetic vulnerability and medical illness, along with the role of psychosocial
stressors and coping style, which the patient may have more control over with
help from the ACS and their own self-activation, provides a useful framework for
discussing the diagnosis of anxiety with patients. The cycle of anxiety model
(next page) can be helpful in discussing the topic of anxiety with patients as it
emphasizes the multiple factors that contribute to anxiety and the ways in which
treatments address these factors. All factors can ultimately cause brain chemical
changes and both medications and CBT can reverse these changes.
THE CYCLE OF ANXIETY
HEALTH HABITS
Poor diet
Inadequate sleep
Caffeine and alcohol use
Lack of exercise
STRESSORS
Medical illness
Pain
Family or Marital problems
Work problems
GENETIC FACTORS
Family history of panic
Early childhood anxiety
THOUGHTS AND FEELINGS
Something is wrong with my body
Worry about everything
Can’t cope
I’m out of control
Depression
PHYSICAL
Muscle Tension
Shortness of breath
Flushing & chills
Palpitations
Chest Pain
Dizziness
CBT TO IMPROVE COPING
BEHAVIOR
Increased doctor visits
because of health
worries.
Avoidance of places
that make me anxious.
Hypervigilance.
Use of alcohol
to cope.
MEDICATIONS
In discussing anxiety with patients, it is quite helpful to mention that:
1. Anxiety is common in primary care.
2. Anxiety can cause or aggravate a wide range of symptoms, including
physical symptoms.
3. Anxiety affects the body, behavior and thinking.
4. Anxiety is an illness, not a character defect or weakness.
5. Recovery from anxiety is the rule, not the exception.
6. The good news is that anxiety can almost always be treated with either
medications or psychotherapy.

57
It can be very useful to refer patients to high-quality sources of information about
anxiety disorders. We particularly recommend the materials available at the
Anxiety Disorders Association of America website (www.adaa.org).
Troubleshooting:
What to Do if Patients Don’t Improve as Expected
When patients do not recover or progress with therapies as expected,
there are a variety of well understood and described factors that are likely
contributing to this failure to progress. These include:
Wrong Diagnosis
Insufficient Dose or Treatment length
Adherence Problem
Side Effects
Ongoing life stressors
Ongoing medical problems
Psychological barriers to recovery
Unrecognized substance abuse
Other co-morbid psychiatric disorders, including personality
disorders
These factors will be carefully evaluated and addressed with a revised
treatment plan during Psychiatric Consultation.

58
Patient Information about Medication
How do anti-anxiety medications work?
Both life stresses and medical problems can change chemical messengers
in the brain that maintain the balance in how you feel emotionally and physically.
Some people are more prone than others to developing these kinds of
imbalances; this tendency may run in families and be at least partly genetic in
origin. This chemical imbalance results in some of the common symptoms of
anxiety such as worry, nervousness, heart palpitations, sweating, digestive
upset, insomnia, and avoidance of stressful situations. Antidepressant
medications, originally developed to treat depression, have been found to be the
most broadly effective medications for a range of anxiety disorders. Thus, these
medications are the most commonly used anti-anxiety medications and can help
restore a normal balance of these chemical messengers, helping to relieve
emotional and physical symptoms.
Antidepressants can take up to 8 weeks to work. It usually takes two to
four weeks until people start feeling better emotionally and physically. This
improvement may be gradual, and often, family members of friends may notice a
difference in how you are doing before you do. Some symptoms may improve
first and other symptoms may take more time to improve. Benzodiazepines
belong to a class of anti-anxiety medication that works more quickly, usually
within a week. These medications are often not the first choice, because they
are not effective against some symptoms, such as depression, that often
accompany anxiety. They also have a potential for abuse, if the person has had
previous or current problems with alcohol or other drugs.
Once you are feeling better, do not stop the medication right away. Your
doctor may recommend taking the medication for 12 months or longer to prevent
a relapse of your anxiety.
How to find the right medication for you:
Scientific studies show that medications do not differ in the percentage of
patients that get better. However, different medications are effective for different
people, and the side effects of the medications differ. Some medications also
may cost more than others. Your doctor can help you decide which medication
may be best for you.
Between 50% and 80% of patients will improve after 4 to 8 weeks on a
medication. By working together, you and your doctor can decide whether the
medication you started is the right one for you. If you need to switch to another
medication because of side effects or because you are not substantially
improved, chances are still excellent that you will improve on a second
medication. Sometimes, medications may be combined, if one works partially,
to get a “full” and complete effect.

59
What about side effects:
Some people experience side effects when taking medications. While
annoying, they are rarely dangerous to your health. They usually occur the first
few weeks and then gradually decrease as your body adapts to the medication.
Because of these early side effects, patients sometimes feel a little worse before
they start getting better and may give up too soon. If you have side effects that
are bothering you, discuss these with your doctor or your anxiety clinical
specialist. Your doctor will help you determine if these side effects will decrease
over time or if you should decrease or switch your medications.
Some of the side effects that can occur with medications include: nausea,
headaches, jitteriness, weight gain, diarrhea, insomnia, sedation, dizziness,
difficulty in achieving orgasm
Remember:
1. Take the medications every day, as prescribed by your doctor.
2. Keep track of any side effects and discuss them with your doctor.
3. Sudden discontinuation of any of these medications can cause
withdrawal symptoms so always taper your medication down before stopping it.
4. It takes 4-10 weeks for most medications to work, with the exception of
benzodiazepines, which can work more rapidly.
5. Continue to take the medication even when you feel better.
6. Don’t stop taking medications before talking with your primary care provider.
Patient Information about CBT
What is CBT?
CBT stands for Cognitive Behavior Therapy. CBT is a well researched form of
therapy that helps people with anxiety problems feel less anxious and stop
avoiding things they would like to do because of anxiety.
How does CBT work?
CBT focuses on helping people change thinking patterns and behavior patterns
that contribute to high levels of anxiety. With the help of a CBT therapist, people
learn how to:
Weaken the connections between tough situations and “knee-jerk” or
habitual reactions to them
Calm their minds and bodies, so they can feel better, think more clearly,
and make more effective decisions

60
Understand how their problems work, what triggers them, and what they
can do to stop the “typical chains” of events that are keeping them from
more satisfying lives
Learn new, more effective ways of coping with distress and regulating
emotions
Understand how certain thinking patterns may contribute to problems and
how to change them.
What is doing the treatment like? What will the therapist ask me to do
exactly?
You can expect your therapist to:
-Listen to what you have to say and be empathetic – they will work to
understand you and what you are experiencing
-Be active in treatment – they work with you to understand and solve your
problems (that means they ask questions and give you feedback, not sit there
silently!).
-Come up with a brief, focused plan to help you start feeling better. CBT
focuses on helping people feel better as soon as possible.
-Be present-focused. This means that a CBT therapist will not assume that
all your problems are due to childhood/past issues. This is NOT to say that if
these are important to you and your treatment, they will not focus on them. It
simply means that unlike some forms of psychotherapy, CBT does not assume
that all our problems are necessarily linked to early childhood issues.
-Work hard with you to decrease your anxiety in and out of sessions!
Will it be a lot of work?
CBT does require activity and work on your part. This is because work and
practice outside of sessions are very important to help you get used to new ways
of responding that don’t keep you anxious all the time! It’s a good idea to think
about doing CBT “all the way”. Your therapist will be with you every step of the
way to help you and provide support. But, it does require work.
I feel really bad. Doesn’t this mean I need medications?
Both CBT and medications are good forms of treatment, and studies show that
both are effective even for severe anxiety. So, feeling really anxious or down
doesn’t mean that CBT is a bad choice.
How long will it take to work?
Everyone responds differently, so it’s hard to say exactly how long it takes for
CBT to work. However, many people start to feel better by around the 4 th
session, and some people experience benefits even sooner.

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Common Questions about Anxiety Medications
1. How do medications work?
Medications help restore the correct balance of certain chemicals
called neurotransmitters in the brain.
2. My problem is inability to sleep. How can medication help this?
In many cases, poor sleep is a by-product of anxiety. Once the
anxiety improves, sleep often improves as well.
Antidepressants can help restore sleep, even in people who do not
have anxiety or depression. They are better than sleeping pills
because they are not habit forming, and are less likely to impair
concentration or coordination.
3. I have a problem with pain. How can anxiety medication help with
this?
Some antidepressants have been shown to be successful in a
number of pain conditions (diabetic neuropathy, phantom limb
pain), even in the absence of anxiety or depression.
Antidepressants may also help restore normal sleep and reverse a
vicious cycle of pain and sleep problems.
4. I have a lot of stress in my life. How can a medication help with
this?
Life stress can worsen symptoms of anxiety. Anxiety can then
worsen the impact of such stressors (such as work stress, family
problems, physical disabilities or financial worries) and your ability
to cope with them. Treating the anxiety can help some patients
break out of this vicious cycle.
5. Are anti-anxiety medications addictive?
The kind of anti-anxiety medication most likely to be recommended
for you will be an antidepressant. Antidepressants are not habitforming
or addictive. They do not produce a high feeling, but slowly
alter the amount of certain chemicals called neurotransmitters in
the brain over a number of weeks. Restoring the levels to a more
normal balance usually brings the depression under control.
Some people have been taking antidepressants continually for up
to 30 years without any significant (physical or psychological)
adverse effects. Still, it is important that the antidepressants not be
stopped suddenly, as side-effects can develop with abrupt
discontinuation.
Benzodiazepines, taken regularly under a doctor’s supervision, are
very unlikely to produce a high or the need for increasing doses

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over time, unless someone already has or has had in the past a
problem with drug or alcohol abuse.
However, benzodiazepines do produce physical tolerance
and so cannot be abruptly discontinued; they must be
gradually tapered down to avoid withdrawal symptoms.
This characteristic is another one of the reasons that
antidepressants are a first choice for anxiety treatment.
6. My problem is more depression than anxiety. How will these
medications help?
In many cases, depression may be a by-product, or later stage, of
anxiety. Antidepressants will help both these conditions.
7. How long will it take the medications to work?
For antidepressants, it usually takes from 4-6 weeks for patients to
start feeling better. Small improvements in some symptoms are not
easily noticeable, although if you keep track of the intensity of your
symptoms with a diary, you can often see differences in 1-2 weeks.
If the anxiety has not improved after 4-6 weeks by at least 25%,
you may need an increase in the dose or change to another
medication.
8. How long will I have to take the medication?
Once you have completely recovered from your anxiety, you should
stay on the medication for at least a year. Deciding to stop after this
depends on how long you had the anxiety before, how intense the
symptoms were, and how much they interfered with your life. Your
primary care provider will help you decide when the time is right to
stop the medication.
For people who have had longstanding problems with anxiety from
childhood or early adulthood, and for people who may have
continuing, ongoing stress in their life due to medical problems or
other life circumstances, continuing the medication may be helpful.
For people who have had shorter problems with anxiety and
periods of feeling very well without anxiety in the recent past, and
for those who are not facing too much ongoing stress, gradually
stopping the medication after a year might make sense.
9. Are there any dangerous side effects?
Side effects from medications are usually mild. You should ask
your doctor or anxiety clinical specialist (who will coordinate with
your doctor) what to expect and what to do if you have a problem.
In many cases, your body will get used to the medication and you
won’t be bothered with the side effect for long. In other cases, your
doctor may suggest you lower the dose, add another medication, or

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change to another medication. If used properly, there are no
dangerous or life-threatening side effects.
If you have any questions or concerns about side effects, you
should not hesitate to bring these up with your primary care
provider. By letting your doctor know how the medicine affects you,
you can help him/her choose the best medication and dose that
work for you.
10. Is it safe to take anti-anxiety medications together with alcohol or
other medications?
In general, antidepressants can be safely taken with other
medications. However, some antidepressants may increase or
decrease the amounts of other medications in the body, so you
should let your doctor or anxiety clinical specialist know exactly
which other medications you are taking so that he/she can be sure
there are not problems.
All anti-anxiety medications, but especially benzodiazepines, can
increase the sedating effects of alcohol. Be careful to avoid alcohol
intake while on these medications. Be especially cautious about
driving or using heavy machinery until you know how these
medications affect you.
11. What should I do if I miss the medication one day?
Don’t “double up” and take the dose you forgot. Just resume taking
your medication as prescribed.
12. Can I stop the medication once I am feeling better?
No. You would be at high risk for having the anxiety come back
and may experience some temporary withdrawal symptoms.
Treatment for at least 12 months makes sense for almost everyone,
and after that, stopping the medication is a decision that must be
individualized for each person, based on the nature and duration of
their anxiety and other emotional problems. It is best to talk about
this with your doctor, and develop a plan for when and how to stop
taking medication.
13. Will I get better?
With adequate treatment, between 50 and 80% of patients will
experience a complete recovery.
Remember, if the first medication or approach does not work, your
doctor will try additional medications or other therapies that are
likely to help you.

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11. HANDLING EMERGENCIES
Acute suicidality-
For patients endorsing acute suicidal ideation while in the presence of the
ACS, the ACS will provide immediate assistance and referral. Initially, the ACS
will ascertain, using our suicide assessment and protocol form (see next page),
how imminent the patient’s risk of self-harm is. If the patient rates their own
suicidality at a level of four or higher on the seven point scale, or if the ACS
suspects that the patient is at that level despite the patient’s own ratings, the
ACS will ascertain whether or not the person can control their impulses to harm
themselves. If the patient indicates that they are incapable, or unsure of their
ability to refrain from harming themselves, the ACS will take the necessary and
recommended steps outlined on our form. In addition, if, for any reason, the ACS
believes the patient is less capable than they indicate of preventing harm to
themselves, they are to proceed with the suicide protocol as it is outlined on our
form. As a matter of protocol, the ACS will make contact with the patient’s PCP
and the study psychiatrist or psychologist to provide further assistance to the
patient, or to simply discuss the event and the actions the ACS took.
Acute manic or psychotic episode-
While people with bipolar 1 disorder or any psychotic disorder should have
been excluded from this study, if manic or psychotic symptoms emerge over the
duration of treatment, the ACS will immediately contact the consulting
psychiatrist and together they will contact the patient’s PCP and devise a
strategy to treat the patient. This may include an immediate in person
consultation with the psychiatrist if feasible, referral to a psychiatric emergency
service if more structure or physical containment is required to manage the
patient, prescription of anti-manic medication, and contacting the person’s
immediate family, significant other, or others living with the person.
Severe side-effects-
If a patient experiences severe side-effects from their prescribed
medication, the ACS will contact the patient’s PCP and refer the patient to their
provider to adjust the patient’s prescription as necessary. Guidelines for
changing prescriptions are laid out in this manual within the medication algorithm.
The study psychiatrist is available for consultation to the PCP at their discretion.
Further, if necessary, the patient may have an in-person session with the
psychiatrist to discuss the prescription options. If the ACS is uncertain whether
an immediate call to the PCP is necessary they may first consult the psychiatrist.
Alcohol and substance abuse (including prescription medications)-
A patient that is found to be misusing or abusing alcohol or drugs will be
referred to their PCP and will be provided with contact information for local drug
or alcohol counseling and rehabilitation services by the ACS. The patient’s PCP
will be alerted to the situation. In addition the ACS will discuss the counter
productivity of substance misuse with regards to their anxiety treatment program.

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Suicidality Risk Assessment and Protocol
The suicide assessment protocol is to be initiated whenever the patient indicates any suicide intent.
Suicide intent is defined as any communication related to wanting to kill oneself or wanting to be
dead, either spoken out loud or indicated on a questionnaire. This protocol should also be initiated if
you have any reason to suspect suicide ideation might be present, even if the patient did not
communicate this directly.
1. On a scale of 1 to 7, what is your intent to kill yourself right now? Date Time
Low 1 2 3 4 5 6 7 High
2. If "4" or higher, ask: Do you believe you could control your impulses? Yes No
3. If ''no'' or if any reason to suspect that the patient is at risk, ask the following:
a) Suicide planning and/or preparation- Do you have a plan on how you would kill yourself?
b) Suicide note written or in progress- Have you written or started a letter to others about killing
yourself?
c) Methods available or easily obtained- Refer back to plan and ask: Do you have
available to you?
d) Precautions against discovery or intervention; deception or concealment about timing, place,
etc. Consider plan and ask: Does anyone know about your plan?
e) Indirect references to own death, arrangements for death- Consider plan and ask: Have you
made any preparations for your death?
f) History of suicide attempts- Have you ever attempted suicide previously?
g) Recent disruption or loss of interpersonal relationship; negative environmental changes in past
month; recent psychiatric hospital discharge-Ask: Have you suffered any recent losses or serious
stressors or changes or problems in your relationships?
h) Isolation- Ask: Have you been particularly isolated lately?
i) Abrupt clinical change, either negative or positive-Ask: Have you recently experienced a drastic
change in your mood-either feeling really "up" or really "down"?
j) Current hopelessness, anger, or both-Ask: Are you currently feeling hopeless (like things will never
get better)? Are you currently feeling a lot of anger?
k) Depressive turmoil, severe anxiety, panic attacks, severe mood cycling-Ask: Are you
experiencing a lot of depression, anxiety, panic attacks or extreme "ups and downs"?
1) Alcohol consumption/drug use-Ask: In the last week, have you been drinking alcoholic beverages
or using recreational drugs? A lot more than normal? Assess frequency quantity, and recency.
Remain with the patient or on the phone until risk is lowered. If over the telephone, tell the patient that you
would like to consult with the study investigator and ask the patient for a commitment not to harm
himself/herself and to stay present and available for a return phone call within the next 10 minutes. Page the
study investigator for directions. Use emergency means (dial 911) if necessary.
Check which actions taken (must always do items in bold):
a. Referred to positive thing(s) in patient's life;
b. Focused on what he/she can do about his/her feelings;
c. Ask patient to list and call people in his/her support network;
d. Made sure he/she had emergency numbers (including crisis line and clinic numbers);
e. Contracted with patient to not harm self or engage in suicidal acts;
f. Ask patient to call for professional help (psychiatrist/therapist/PCP/crisis line/ER);
g. Had patient call you back to confirm patient took positive actions;
h. Referred patient to clinic staff/PCP in waiting room;
i. Accompanied patient to Emergency Room;
j. Contacted 911 (danger to life is imminent and patient refuses help); Time
k. Contacted CDMHP office; Who did you speak with?
l. Contacted subject’s PCP within 24 hours; Date Time
m. Contacted Study Investigator within 24 hours; Date Time
n. Other
o. Completed Adverse Event Report

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12. SUPPORTING MATERIALS
This manual makes reference to numerous consensus guidelines and
reviews of evidence-based studies supporting the recommendations
contained herein. Following is a list of supporting materials for these
statements of fact and other recommendations that were used in
preparing and documenting this manual.
C. Allgulander, B. Bandelow, E. Hollander, S. A. Montgomery, D. J. Nutt, A. Okasha, M. H.
Pollack, D. J. Stein, and R. P. Swinson. WCA recommendations for the long-term treatment of
generalized anxiety disorder. CNS.Spectr. 8 (8 Suppl 1):53-61, 2003.
J. C. Ballenger, J. R. T. Davidson, Y. Lecrubier, D. J. Nutt, J. Bobes, D. C. Beidel, Y. Ono, and H.
G. M. Westenberg. Consensus statement on social anxiety disorder from the International
Consensus Group on Depression and Anxiety. J Clin Psychiatry 59 (suppl. 17):54-60, 1999.
J. C. Ballenger, J. R. Davidson, Y. Lecrubier, D. J. Nutt, E. B. Foa, R. C. Kessler, A. C.
MacFarlane, and A. Y. Shalev. Consensus statement on posttraumatic stress disorder from
the International Consensus Group on Depression and Anxiety. J Clin Psychiatry 61 (suppl
5):60-66, 2000.
D. L. Chambless and S. D. Hollon. Defining empirically supported therapies. J Consult
Clin.Psychol. 66 (1):7-18, 1998.
J. R. Davidson. Use of benzodiazepines in social anxiety disorder, generalized anxiety disorder,
and posttraumatic stress disorder. J Clin.Psychiatry 65 Suppl 5:29-33, 2004.
A. C. Doyle and M. H. Pollack. Establishment of remission criteria for anxiety disorders. J
Clin.Psychiatry 64 Suppl 15:40-45, 2003.
G. Fricchione. Clinical practice. Generalized anxiety disorder. N.Engl.J Med 351 (7):675-682,
2004.
J. P. Hambrick, J. W. Weeks, G. C. Harb, and R. G. Heimberg. Cognitive-behavioral therapy for
social anxiety disorder: supporting evidence and future directions. CNS.Spectr. 8 (5):373-381,
2003.
F. Kapczinski, M. S. Lima, J. S. Souza, and R. Schmitt. Antidepressants for generalized anxiety
disorder. Cochrane Database Syst Rev (2):CD003592, 2003.
B. A. Lauria-Horner and R. B. Pohl. Pregabalin: a new anxiolytic. Expert.Opin.Investig.Drugs 12
(4):663-672, 2003.
M. R. Mavissakalian and J. M. Perel. Long-term maintenance and discontinuation of imipramine
therapy in panic disorder with agoraphobia. Arch.Gen Psychiatry 56 (9):821-827, 1999.
A. Raj. Overview and treatment of social anxiety disorder. Manag.Care 13 (6 Suppl
Depression):52-57, 2004.
M. A. Raskind, E. R. Peskind, E. D. Kanter, E. C. Petrie, A. Radant, C. E. Thompson, D. J. Dobie,
D. Hoff, R. J. Rein, K. Straits-Troster, R. G. Thomas, and M. M. McFall. Reduction of
nightmares and other PTSD symptoms in combat veterans by prazosin: A placebo-controlled
study. Am.J.Psychiatry 160 (2):371-373, 2003.

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K. Rickels, M. H. Pollack, D. E. Feltner, R. B. Lydiard, D. L. Zimbroff, R. J. Bielski, K. Tobias, J. D.
Brock, G. L. Zornberg, and A. C. Pande. Pregabalin for treatment of generalized anxiety
disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and
alprazolam. Arch Gen Psychiatry 62:1022-1030, 2005.
E. N. Ringdahl, S. L. Pereira, and J. E. Delzell, Jr. Treatment of primary insomnia. J Am.Board
Fam.Pract. 17:212-219, 2004.
J. F. Rosenbaum and M. H. Pollack. The pharmacotherapy of panic disorder. In: Panic Disorder
and Its Treatment, edited by J. F. Rosenbaum and M. H. Pollack, New York:Marcel Dekker,
Inc., 1998, p. 153-180.
P. P. Roy-Byrne, M. B. Stein, A. Bystritsky, and W. Katon. Pharmacotherapy of panic disorder:
Guidelines for the family practitioner. Journal of the American Board of Family Practice
11:282-290, 1998.
F. B. Schoenfeld, C. R. Marmar, and T. C. Neylan. Current concepts in pharmacotherapy for
posttraumatic stress disorder. Psychiatric Services 55:519-531, 2004.
J. Sareen and M. B. Stein. Pharmacotherapy for anxiety disorders in the new millenium. Psychiatr
Clin North Am 7:173-186, 2000.
S. Seedat and M. B. Stein. Double-blind, placebo-controlled assessment of combined
clonazepam with paroxetine compared with paroxetine monotherapy for generalized social
anxiety disorder. J.Clin.Psychiatry 65 (2):244-248, 2004.
D. J. Stein, M. Versiani, T. Hair, and R. Kumar. Efficacy of paroxetine for relapse prevention in
social anxiety disorder: a 24-week study. Arch Gen Psychiatry 59:1111-1118, 2002.
M. B. Stein, M. R. Liebowitz, R. B. Lydiard, W. Bushnell, and I. P. Gergel. Paroxetine treatment of
generalized social anxiety disorder (social phobia): a randomized controlled trial. Journal of
the American Medical Association 280:708-713, 1998.
M. B. Stein, C. D. Sherbourne, M. G. Craske, A. Means-Christensen, A. Bystritsky, W. Katon, G.
Sullivan, and P. P. Roy-Byrne. Quality of care for primary care patients with anxiety disorders.
Am J Psychiatry 161:2230-2237, 2004.
M. Van Ameringen, C. Allgulander, B. Bandelow, J. H. Greist, E. Hollander, S. A. Montgomery, D.
J. Nutt, A. Okasha, M. H. Pollack, D. J. Stein, and R. P. Swinson. WCA recommendations for
the long-term treatment of social phobia. CNS.Spectr. 8 (8 Suppl 1):40-52, 2003.

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13. Acknowledgments
We are grateful for the consultation and advice of Jeanne Miranda PhD
and David Takeuchi PhD who reviewed and provided comments regarding
the section on working with ethnic minority and disadvantaged patients.
We also wish to express our thanks to the many psychiatrists,
psychologists, nurses, primary care physicians, other allied health
professionals, and healthcare consumers who have shared their anxiety
treatment experiences with us over the years. Although this manual is
intended to strongly favor the implementation of evidence-based
guidelines, the authors recognize that such guidelines are sorely lacking
when it comes to the treatment of refractory anxiety disorders, in
particular. Thus, many of the recommendations contained herein stem
from the experiences of skilled clinicians, whose clinical wisdom is used to
buttress the hard evidence when such evidence is lacking. We trust that
this will be a temporary state, and that the evidence base will grow to fully
meet the needs of practitioners in the years to come.
We are also grateful to the physician-investigators at the University of
Seattle and Group Health Cooperative in Seattle – including Jurgen
Unutzer, Greg Simon, and Wayne Katon, among others – upon whose
work in depression in primary care our own work in general, and this
manual in principle, is patterned.
This work was supported by NIMH grants to the authors.