Professor Michael Barkham The PRaCTICED Trial

The design of the PRaCTICED trial:Decisions, decisions, decisionsMichael Barkham Centre for Psychological Services Research University of Sheffield Metanoia: September 2013

Acknowledgements• BACP Research Foundation• Nancy Rowland & Andy Hill (BACP)• Dave Saxon & Jo-Ann Pereira (CPSR, Sheffield)• Lynne Laycock & Trish Hobman (York St John)• Samantha Montague, Paul Bliss, Joan Davies,Helen Knight, & Simon Bennett (Sheffield IAPT service)• Sheffield IAPT: Counsellors, CBT therapists, &Psychological Wellbeing PractitionersCPSR, University of Sheffield 2

Overview• Provide the context of the PRaCTICED trial• Present the major components of the trial– Design– Participants– Interventions• Overview of research questions• ReflectionsCPSR, University of Sheffield 3

THE TRIAL: THE CONTEXT CPSR, University of Sheffield 4

Decisions, Decisions, DecisionsCPSR, University of Sheffield 5

DecisionsIn clinical work…..……at theshops…..…….and in research.CPSR, University of Sheffield 6

Trials and tribula?ons • Evidence-­‐base culture and climate • RCT is dominant as evidence for informing NICE guidelines • Viewed as the gold standard for evidence – The double A bias • Alloca?on -­‐ randomisa?on • Ascertainment – blinding in data collec?on and analysis CPSR, University of Sheffield 7

The colander effect CPSR, University of Sheffield 8

Practice-based evidence: Reprivileging practitionersCPSR, University of Sheffield 9

Chiasmus CPSR, University of Sheffield 10

THE TRIAL: THE COMPONENTS CPSR, University of Sheffield 11

Why this trial & why now?The call for researchCPSR, University of Sheffield 12

Pragma?c Randomised Controlled Trial assessing the non-­‐Inferiority of Counselling and its Effec?veness for Depression • Funded by BACP ResearchFoundation• Start date: January 2014• 18-months data collection• End date: December 2016• Report due mid-2017• Pragmatic• Randomised Controlled Trial• Counselling• Non-Inferiority• Effectiveness for depressionCPSR, University of Sheffield 13

Pragma?c • Greater relevance to rou?ne seSngs • More plausible to prac??oners • Enhanced external validity • Employing interven?ons that are viable op?ons for prac??oners • Decision: to locate the trial within the Sheffield IAPT service CPSR, University of Sheffield 14

Trial nested within a routine practice:Comprehensive cohort designSheffield IAPT service PRaCTICED trial Standard IAPT service Trial data Anonymised rou?ne data from electronic download Key common measures Decision: To investigate the trial outcomes with routine practiceCPSR, University of Sheffield 15

Single site vs. multi-centred trialDecision: To adopt a single site trialCPSR, University of Sheffield 16

Randomised controlled trial• Randomisa?on • Comparison or control group – No treatment – Wait list – Self-­‐help – Minimal contact – Ac4ve psychological interven4on – Psychotropic medica?on Decision: To compare CfD with CBT (upwards of 20 sessions)CPSR, University of Sheffield 17

Pre-treatment, post-treatment, and follow-upmeasures• Trial requirement • Beck Depression Inventory-­‐II (BDI-­‐II) • CORE-­‐OM • EQ-­‐5D • IAPT service requirement (mandatory) • PHQ-­‐9 (and at each session) – primary outcome • GAD-­‐7 (and at each session) • WASAS CPSR, University of Sheffield 18

Non-­‐inferiority trial Decision: Adopt a non-­‐inferiority design Index of non-­inferiority is 2 points on PHQ-­‐9 Non-­‐inferiority trial requires 550 to start treatment – 275 per treatment arm CPSR, University of Sheffield 19

Severity• D Decision: to set severity range as moderate and severeCPSR, University of Sheffield 20

THE TRIAL: THE INTERVENTIONS CPSR, University of Sheffield 21

• Counselling for Depression (CfD) Interven?ons: CfD – IAPT competencies framework and curriculum – Hill & Sanders (in press) Counselling for Depression – 5-­‐day training from York St John – 2-­‐day training in EFT from University of Stathclyde – Mee?ng IAPT standards • Adherence – Supervision tool – Person-­‐Centred and Experien?al Psychotherapy Scale (PCEPS-­‐10 for ongoing monitoring) – PCEPS (15 item) for rated tapes (randomly selected) – External audi?ng of standards by expert group CPSR, University of Sheffield 22

Interven?ons: CBT • Cogni?ve Behavior Therapy (CBT) – IAPT competencies framework and curriculum – Texts based on Beckian approach • Beck et al. (1979). CogniIve Therapy for Depression • Beck & Alford (2009). Depression: Causes and treatment – Enhanced training via workshop (Nov/Dec) – Mee?ng IAPT standards • Adherence – Supervision tool – CTS-­‐R on randomly sampled tapes – External audi?ng of standards by expert group CPSR, University of Sheffield 23

Patient throughputStep-­‐Up Mee4ng: PWP PHQ-­‐9 >12, Ascertain no preference, Introduce Trial, Give info pack, including full consent form. Inform researcher Therapy starts (N=550) CfDCBTTherapy ends Client: On WL for both CBT & CfD Client: On WL for randomised therapy (removed from other therapy WL) Researcher: Contacts client 1 month before therapy due to start to arrange screening Screening Interview: By researcher (2-­‐3 weeks before therapy due to start) Full consent, CIS-­‐R, BDI-­‐II. RANDOMISATION 6 month post randomisa4on (6m Follow-­‐up): Client contacted by researcher for measures 12 month post randomisa4on (12m Follow-­‐up): Client contacted by Researcher for measures CPSR, University of Sheffield 24

THE TRIAL: THE PEOPLE CPSR, University of Sheffield 25

The investigators: Expertise & allegianceCPSR, University of Sheffield group• Michael Barkham (PI) – Clinicalpsychology• David Saxon – PM – data expert &statistician• Mike Bradburn – medical statistician• John Brazier – health economist• Gillian Hardy – clinical & organisationalpsychology• Stephen Kellett – CBT/IAPT service• Sue Shaw – service user• Glenn Waller – CBT (adherence)Sheffield IAPT service• Simon Bennett – IAPT serviceNa?onal group • Peter Bower (Manchester)– research design • Michael King (London) – research design • Stephen Pilling (London) -­‐ NICE • Lynne Gabriel (York St John) – CfD training/adherence • Robert Ellioj (Strathclyde) – EFT training (adherence) International advisors: William B Stiles, Louis Castonguay, Wolfgang LutzCPSR, University of Sheffield 26

• The practitionersThe prac??oners – In the region of 30+ for each of PWPs, counsellors, andCBT practitioners– Overwhelming commitment to the trial from counsellorsand from CBT practitioners– Endorsement from the IAPT service and support fromservice managers– Multi-level meetings with practitioners, leads, andmanagers– Presentations at local IAPT eventsCPSR, University of Sheffield 27

Prac??oner engagement CPSR, University of Sheffield 28

The art of prac?ce Scien4fic Input (technical) Ar4s4c Input (personal) Empathy Output Resilience Prac??oner’s perspec?ve Inter-­personalstyle What do prac??oners bring as people when they deliver effec?ve prac?ce? CPSR, University of Sheffield Mindfulness 29

Patient engagement in trial• A total of 550 pa?ents to enter the trial • Every pa?ent offered an assessment interview receives a one-­‐day free bus pass – Decision: To facilitate entry into the trial and lessen any poten?al systema?c bias that favours bejer off pa?ents travelling to assessment in their locality • Every pa?ent in the trial receives a £10 shopping token with the 6-­‐month and 12-­‐month assessment bajery – Decision: To retain as many pa?ents in the trial as possible CPSR, University of Sheffield 30

Additional data collection• Measure of patient preference & resilience• Individual telephone interviews for people who dropout• Selected telephone interviews at end of therapy toelicit personal accounts of the change process• Third-party ratings of alliance as a predictor ofchange (via DClinPsy projects)Decision: To minimise data collection burden onpatientsCPSR, University of Sheffield 31

Research questions• Are the outcomes of CfD non-­‐inferior to those of CBT? • Is CfD as cost-­‐effec?ve as CBT? • Are the outcomes of pa?ents in the rou?ne service (and those who decline the trial) as effec?ve as those in the trial? • What is the extent of therapist effects? • Does adherence to the therapeu?c model predict outcome? • Are resilience and alliance predictors of outcome? • Are the drop out rates equivalent for both treatments? • Why do people leave treatment early? • What accounts for pa?ent experienced change? CPSR, University of Sheffield 32

THE TRIAL: THE PRINCIPLES CPSR, University of Sheffield 33

Reflections• Key principles of PRaCTICED• Equipoise• Quality (control)• Utility• Integrity• Pluralistic (methods)• Open (processes)• Inclusivity• Support• Even playing fieldThank youCPSR, University of Sheffield 34