The design of the PRaCTICED trial: Decisions, decisions, decisions

Transcription

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

2 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 Practitioners 2

3 Overview Provide the context of the PRaCTICED trial Present the major components of the trial Design Participants Interventions Overview of research questions Reflections 3

4 THE TRIAL: THE CONTEXT 4

5 Decisions, Decisions, Decisions 5

6 Decisions In clinical work.. at the shops...and in research. CPSR, University of Sheffield 6

7 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 7

8 The colander effect 8

9 Practice-based evidence: Reprivileging practitioners CPSR, University of Sheffield 9

10 Chiasmus 10

11 THE TRIAL: THE COMPONENTS 11

12 Why this trial & why now? The call for research 12

13 Pragma?c Randomised Controlled Trial assessing the non- Inferiority of Counselling and its Effec?veness for Depression Funded by BACP Research Foundation Start date: January months data collection End date: December 2016 Report due mid-2017 Pragmatic Randomised Controlled Trial Counselling Non-Inferiority Effectiveness for depression 13

14 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 14

15 Trial nested within a routine practice: Comprehensive cohort design Sheffield 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 practice 15

16 Single site vs. multi-centred trial Decision: To adopt a single site trial CPSR, University of Sheffield 16

17 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) 17

18 Pre-treatment, post-treatment, and follow-up measures 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 18

19 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 19

20 Severity D Decision: to set severity range as moderate and severe 20

21 THE TRIAL: THE INTERVENTIONS 21

22 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 22

23 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 23

24 Patient throughput Step- Up Mee4ng: PWP PHQ- 9 >12, Ascertain no preference, Introduce Trial, Give info pack, including full consent form. Inform researcher Therapy starts (N=550) CfD Therapy ends CBT 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 24

25 THE TRIAL: THE PEOPLE 25

26 The investigators: Expertise & allegiance group Michael Barkham (PI) Clinical psychology David Saxon PM data expert & statistician Mike Bradburn medical statistician John Brazier health economist Gillian Hardy clinical & organisational psychology Stephen Kellett CBT/IAPT service Sue Shaw service user Glenn Waller CBT (adherence) Sheffield IAPT service Simon Bennett IAPT service Na?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 Lutz 26

27 The practitioners The prac??oners In the region of 30+ for each of PWPs, counsellors, and CBT practitioners Overwhelming commitment to the trial from counsellors and from CBT practitioners Endorsement from the IAPT service and support from service managers Multi-level meetings with practitioners, leads, and managers Presentations at local IAPT events 27

28 Prac??oner engagement 28

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

30 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 30

31 Additional data collection Measure of patient preference & resilience Individual telephone interviews for people who drop out Selected telephone interviews at end of therapy to elicit personal accounts of the change process Third-party ratings of alliance as a predictor of change (via DClinPsy projects) Decision: To minimise data collection burden on patients 31

32 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? 32

33 THE TRIAL: THE PRINCIPLES 33

34 Reflections Key principles of PRaCTICED Equipoise Quality (control) Utility Integrity Pluralistic (methods) Open (processes) Inclusivity Support Even playing field Thank you 34