Cognitive-Behavioral Strategies for Non-Adherence Behavior

Cognitive Behavioral Strategies

in the Treatment of Chronic Pain

and Non- Adherence Behavior

Lisa A. Marsch, Ph.D.

Director, Center for Technology and Health (CTH),

National Development & Research Institutes (NDRI)

and

HealthSim, LLC

&

Andrew Rosenblum, Ph.D.

Director, Institute for Treatment & Services Research, NDRI

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Acknowledgement

Research funded by U.S. National

Institute on Drug Abuse (NIDA),

National Institutes of Health (NIH)

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Disclosure

Dr. Marsch is affiliated with HealthSim, LLC,

the small business that developed the web-

based interventions described in this

presentation.

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Combined Psychosocial and

Pharmacological I nterventions

in the Treatment of Chronic Pain

• Although opioid therapy has gained increasing acceptance as a

treatment for chronic pain, concerns persist related to achievement

of treatment goals (reduction in pain severity and pain interference)

and aberrant drug-related behavior

• Psychosocial approaches (particularly self-management strategies such

as cognitive-behavior therapy) have been found to be efficacious for

the treatment of chronic pain

• Psychosocial interventions combined with pharmacological

interventions may improve treatment outcomes and potentially reduce

aberrant drug- related behavior in chronic pain patients

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Cognitive Behavior Therapy (CBT)

for Chronic Pain

• CBT for chronic pain emphasizes that pain severity and pain interference

with physical and emotional function are profoundly influenced by

psychosocial factors

• CBT typically combines stress management, problem solving, goal setting,

pacing of activities and assertiveness

• CBT for chronic pain generally produces moderate effect sizes in improving

pain experience, mood and affect, negative coping, positive coping, pain

behavior and activity level, and social role function

• CBT may be particularly helpful to patients receiving opioid therapy and

displaying aberrant behaviors (to address medication adherence and

misconceptions about opioids), but is infrequently provided to pain patients

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Challenges to Delivering Effective

Psychosocial I nterventions for Chronic Pain

and Aberrant Drug- Related Behavior

• Limited financial and staffing resources to provide evidence-based

psychosocial interventions in primary care or pain treatment settings

• CBT interventions can be complex and require considerable staff f training

• CBT interventions can be time-intensive intensive to deliver

• Difficult to ensure fidelity of intervention delivery

• Limited accessibility for some chronic pain patients

• Innovative approaches to bridging the gap between clinical research earch and

practice are needed, thus allowing findings from clinical research earch to have

a markedly increased impact.

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Proposed Response for Delivering Effective

Psychosocial I nterventions for Chronic Pain

and Aberrant Drug- Related Behavior

Technology-based therapeutic tools offer great promise for

enabling the widespread dissemination of evidence-based

treatment interventions targeting chronic pain and aberrant

drug-related related behavior

Technology-based (e.g., web-based, based, mobile-technology

delivered) interventions allow complex interventions to be

delivered with fidelity at a low cost, without increasing

demands on staff time or training needs, thus having high

potential for widespread dissemination.

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Potential Benefits of

Technology- Delivered I nterventions

Low Cost

Accessible in a wide array of settings

Easily exportable

Fidelity/Replicability is assured

May be less threatening when addressing sensitive topics

Requires active responding

Can be readily modified

Permits temporal flexibility

Permits more rapid diffusion

May increase adoption of science-based interventions

Tailoring/Customization Readily Accomplished

Permits expansion of treatment

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Our Research Focused on Promoting

Widespread Reach of Evidence- based

I nterventions

• We have developed and evaluated (in clinical trials research

funded

by the National Institute on Drug Abuse) technology-based

interventions targeting substance abuse treatment among adults

and adolescents, as well as substance abuse prevention among

children and adolescents, and HIV prevention among youth and

adults.

• These therapeutic tools employ science-based content as well as

informational technologies and multimedia approaches of

demonstrated efficacy.

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Our Research Focused on Promoting

Widespread Reach of Evidence- based

I nterventions (continued)

Our results from this line of research have demonstrated that

technology-based interventions can be as efficacious as

science-based interventions delivered by highly trained

clinicians, cost-effective, and highly acceptable to a

wide variety of target populations

(e.g., in promoting skills training and drug abstinence in

individuals with substance-use use disorders; in reducing HIV risk

behavior in adults & youth).

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Our Technology- Based Substance Abuse

Treatment Programs

Therapeutic Education System (TES), an interactive, web-based

psychosocial intervention for substance use disorders,

grounded in the Community Reinforcement Approach (CRA)

+ Contingency Management Behavior Therapy + HIV Prevention

(Bickel, Marsch et al., 2008)

TES has been evaluated with opioid-dependent dependent individuals and

is being evaluated with poly-substance users in community-

based substance abuse treatment (NIDA’s s multi-site, Clinical Trials

Network (CTN) platform) and on the CJ-DATS platform with individuals

in prisons.

Web-Based Psychosocial Treatment for Adolescents with

Substance Use Disorders

Embedding interactive, psychosocial treatment elements of TES

on mobile devices for therapeutic support on-demand

We now plan to modify TES to create modules to deliver CBT to

opioid-treated,

chronic pain patients displaying aberrant drug-

related behavior.

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Therapeutic Education System (TES)

for Substance Abuse Treatment

Composed of 65 interactive modules grounded in the efficacious

Community Reinforcement Approach (CRA) psychosocial intervention

Program is self-directed & includes a Training Module

Therapists/Patients can use “customization plan” to establish

individualized treatment plan for patients based on treatment needs

Patients complete evidence-based program modules on skills training,

interactive exercises and homework in accordance with their plan

All module content includes accompanying audio

Electronic reports of patients’ activity available to therapists

Can track earnings of incentives dependent on urine results or

other target behavior

New content can be readily added to the content delivery system

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List of Module Topics in Therapeutic Education System (TES)

1 Training Module

2 What is a Functional Analysis

3 Conducting a Functional Analysis

4 Self -Management Planning

5 Drug Refusal Skills Training

6 Awareness of Negative Thinking

7 Managing Negative Thinking

8 Managing Thoughts About Using

9 Managing Negative Moods and Depression

10 Introduction to Problem Solving

11 Effective Problem Solving

12 Progressive Muscle Relaxation Training

13 Receiving Criticism

14 Seemingly Irrelevant Decisions

15 Other Drug Use

16 Coping with Thoughts About Using

17 Introduction to Assertiveness

18 How to Express Oneself in an Assertive Manner

19 Introduction to Anger Management

20 How to Become More Aware of the Feeling of Anger

21 Coping with Anger

22 Introduction to Relaxation Training

23 Progressive Muscle Relaxation Generalization

24 Introduction to Giving Criticism

25 Steps for Giving Constructive Criticism

26 Receiving Criticism

27 Giving and Receiving Compliments

28 Sharing Feelings

29 Vocational Counseling

30 Naltrexone

31 Limited Alcohol Use

32 Financial Management

33 Insomnia

34 Time Management

35 Relationship Counseling - Part 1

36 Relationship Counseling - Part 2

37 Relationship Counseling - Part 3

38 Alcohol and Disulfiram

39 Communication Skills

40 Nonverbal Communication

41 Social Recreational Counseling

42 Attentive Listening

43 HIV and AIDS

44 Sexually transmitted infections (STIs)

45 Hepatitis

46 Sexual transmission of HIV and STIs

47 The Female Condom

48 Birth control use and HIV and STIs

49 Drug Use, HIV and Hepatitis

50 Alcohol use and risk for HIV, STIs and hepatitis

51 Getting Tested for HIV, STIs and Hepatitis

52 Finding More HIV, STI and Hepatitis Information

53 Negotiating Safer Sex

54 Decision-Making - Skills

55 Identifying/managing triggers for risky sex

56

57

Identifying and Managing Triggers for Risky Drug Use

Increasing -Self-Confidence in Decision Making

58 Taking Responsibility for Choices

59 Living with Hep C: Managing Treatment, Promoting Health

60 Living with Hep C: Coping Skills

61 Living with HIV: Coping skills and managing stigma

62 Living with HIV: Comm. skills for disclosing HIV status

63 Living with HIV: Managing treatment and medications

64 Living with HIV: Drug use and Immune System

65 Living with HIV: Daily routines to promote health

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Evidence- Based I nformational Technologies

employed in I nterventions

Fluency-Based Computer-Assisted I nstruction (CAI )

A learning technology that involves testing, providing immediate

feedback, & requiring participants to demonstrate mastery of the

information & skills being learned

Selectively presents information

Requires active, overt responding by the user to multiple

choice and fill-in-the-blank questions

Evaluates and provides immediate feedback on user’s responses

“Read & Response timing parameters” are manipulated in

promoting fluency

I nteractive Video-based Computer Simulation

Simulates real-world experiences and enables “what if”

scenarios & behavioral modeling

Enables exploration of various behavioral choices

in “experiential learning” paradigm

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Therapeutic Education System (TES)

Flow of User Activity

User Log-In

If First Use:

After First Use:

Training Module

Customization Program

Drug use since last session

Assessed/CM delivered

If YES,

If NO,

Functional Analysis &

Self-Management Planning

Proceed to Next Module

In Customized Plan

Composed of learning

tools including:

Fluency-Based CAI

Interactive Videos

Graphics

Interactive Exercises

User activity stored in

Database & Electronic

Summary Reports Sent

to/Viewable By Therapists

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Back- end Administrator

Functions of TES

• To track patient progress (“dose(

dose” of intervention)

• To view detailed reports of patient activity

• To view aggregated patient data

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Randomized Controlled Trial of TES

Participants were opioid-dependent individuals in buprenorphine

maintenance treatment for 23 weeks

Participants randomly assigned to one of three groups:

Therapist Delivered CRA: 30 mins. 3x/wk. w/therapist + vouchers

Computer Assisted CRA: 30 mins.3x/wk. computer; 1 biweekly w/therapist

+ vouchers

Standard Counseling: 30 mins. 1/wk. w/therapist - focus on rehabilitation

& compliance with treatment program

Vouchers for both cocaine and opioid-free urine samples

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Treatment Retention

by Treatment Week

100

Computer

Therapist

Standard

Percent Retained in Study

90

80

70

60

50

40

30

20

10

0

0 5 10 15 20

Study Week

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Continuous Abstinence from

Opiates and Cocaine

12

Standard

10

a

a

Therapist

Computer

Treatment Weeks

8

6

4

b

2

0

Continuous Abstinence from

Opiates and Cocaine

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Abstinence Plotted

by Therapist Contact Time

Mean Weeks of Continuous

Opioid and Cocaine Abstinence

8

7

6

5

4

3

2

1

0

Computer-assisted Therapist-delivered

Standard

0 200 400 600 800 1000 1200

Average Contact Time with Therapists

(in minutes)

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Summary of Clinical Trial Results

The therapist-delivered and computer-assisted CRA interventions

produced comparable weeks of continuous opioid & cocaine

abstinence and significantly greater weeks of abstinence than the

standard intervention, yet participants in the computer-assisted

condition had over 80% of their intervention delivered by an

interactive computer program.

The comparable efficacy obtained with computer-assisted and

counselor-delivered therapy may enable more widespread

dissemination of the evidence-based CRA plus vouchers intervention

in a manner that is cost-effective and ensures treatment fidelity.

Clinicians can use this tool to ensure that their patients have

access to evidence-based skills training relevant to their

treatment (and can optionally guide the focus of the intervention).

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TES for Chronic Pain Patients with

Aberrant Drug- Taking Behavior

Educational Component – e.g., education about pain, opioids,

aberrant behavior and addiction; cognitive restructuring to challenge

negative perceptions regarding abilities and understand role of

thoughts and emotions in maintaining stress and physical symptoms

Acquisition of Self-Management – e.g., activity, rest and pacing,

relaxation; combating fatigue; coping self-statements; attention

diversion; preventing pain from ruining relationships; optional module

on identifying/managing triggers for risky drug use

Skill Consolidation – practice/rehearse skills learned during

acquisition phase

Generalization and Maintenance – help solidify skills and prevent

relapse

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I terative Development Process in Creating

Technology- based I ntervention

• Expert Input

• Focus Groups with chronic pain patients to provide input

into program development

• Development of Beta version

• “Feedback Sessions” on Beta version from experts

• “Feedback Sessions” on Beta version from members of target

audience

• Development of “Gold version” of program

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Randomized, Controlled Trial

• Chronic pain patients maintained on opioid medications who

exhibit aberrant drug-taking behavior (n= 110) will be

randomized to:

(1) Treatment as Usual (TAU) in pain management program

(2) TAU plus web-based based psychosocial intervention

• 12- week intervention with 1-1

and 3-3

month follow- ups

• We will evaluate the relative efficacy of these interventions s on:

Primary Outcomes: pain severity, pain interference behaviors and drug-

related aberrant behavior

Secondary Outcomes: substance misuse, other pain behaviors,

psychiatric distress, health functioning, quality of life, positive ive affect,

treatment satisfaction

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Opportunities with Technology- based

I nterventions

A web-based intervention may markedly improve the treatment of

chronic pain by enabling widespread access to evidence-based CBT

A technology-based approach to intervention delivery creates new

opportunities and outlets for intervention efforts.

Technology-based interventions can transcend geographic

boundaries and may be used in a wide variety of settings,

including home, primary care physician offices, specialty programs,

mobile devices, and online social networks.