Behavioural Activation for Depression. The story so far and the rise of COBRA. David Ekers PhD, MSc, ENB 650 (CBT), RMN

Transcription

1 Behavioural Activation for Depression. The story so far and the rise of COBRA David Ekers PhD, MSc, ENB 650 (CBT), RMN

2 What is Behavioural Activation Views depression as based in interaction with environment-loss of positive reinforcement Uses behavioural theory Largely forgotten in favor of CBT over past 3 decades Potentially simple to deliver possibly suited to wider dissemination less moving parts This may then be of particular use if it remains as effective

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4 Three core components that underpin BA Self-monitoring Used to reinforce rationale and build a shared understanding of the persons problems, the patterns of mood and the types of activity that are of value Functional analysis Used to help break down situations to identify the triggers (Antecedents), responses (Behaviour), what happens after (Consequence). Used to problem solve blocks to: Activity Scheduling Used to plan schedules, help person gradually begin to work from outside in in a value direction so environment provides positive reinforcement

5 RESEARCH STORY SO FAR

6 Landmark study-component Analysis of CT for Depression (Jacobson et al 1996) 150 Patients with major depression identified for study random allocation to arms Behavioural Activation alone Activation and thought modification Full CT Baseline (n=57) Basleline (n=44) Baseline (n=50) 6 month 6 month 6 month 2year 2 year 2 year

7 Systematic review and Meta-analysis of behavioural treatment for depression Psychological Medicine 2008; 38(5):

8 Findings BA vs. Control/Usual Care 12 studies (459 participants) Effect size in favour of BA (large) (95% CI 0.39 to 1, p=0.001), recovery rate favours BA OR= 4.18 CI 1.14 to (p=0.03) BA vs. CT/CBT Twelve studies (476 patients) No difference effect size at post treatment and follow up (SMD % CI 0.14 to 0.30, SMD of 0.25, 95% CI 0.21 to 0.70, p=0.28) or recovery rate (OR 0.92, 95% CI 0.59 to1.44, p=0.72)

9 Possible implications of findings BA works compared to control No apparent added benefit of cognitive components BA appears strong in relation to other therapies

10 Limitations of evidence base No cost analysis/small studies/limited numbers in comparisons beyond BA vs. Control and CBT All experienced therapists So still big questions Does BA s equivalence maintain with less qualified therapists? (as per Jacobson 1996) Parsimony- but if a simple intervention is delivered by expert therapists what is active ingredient? No help to improving access to evidenced based therapies if reliant on experts Do we need more therapies for delivery by the same therapists??

11 Behavioural activation delivered by the non specialist: Phase II randomised controlled trial D Ekers, D. Richards, S Gilbody, D McMillan & M Bland British Journal of Psychiatry 2011

12 Clinical Results BA superior on all measures with large effect and more recovery BDI-II difference post in favour of BA Completers (95% CI 6.90 to 24.41) SMD 1.15 ( 1.85 to 0.45) ITT in favour of BA (95% CI to 7.02, p= 0.001) WASA in favour of BA Completers ( 4.79 to 18.33) p=0.001 SMD 1.14 ( 1.84 to 0.45) ITT in favour of BA (95% CI to 4.70, p= 0.001) Satisfaction BA: 29 on 32 point scale, Better than usual care p=0.001 Strong adherence on checklist

13 Economic Analysis Ekers D, Godfrey C, Gilbody S, Parrott S, Richards D, Hammond D and Hayes A. (In Press BJ Psych)

14 Effect Difference Cost more/less effective 2,000 Cost more/more effective 1,500 1, ,000-1,500 Cost less/less effective - 2,000 Cost Difference Cost less/more effective

15 ICER based upon 1000 bootstrapped replications = 5,006 5,756 97% likelihood that the additional cost of BA over usual care per QALY gained is less than 20,000,

16 Small sample 2 therapists No follow up Small Study - Big Limitations But helped us in looking at the proof of principle

17 BA EVIDENCE UPDATE AND SUB GROUP ANALYSIS

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19 29 studies-36 comparisons BA vs. controls (1387 participants) Effect size maintains at the large level vs. control 0.72 (95% CI 0.88 to 0.55 p<0.001 NNT 2.5) Moderate level of dispersion across studies 41% No study had a significant effect on overall results Vs. medication results 4 studies, 5 comparisons 288 participants 0.37 (95% CI 0.74 to 0.05 p 0.05 NNT 4.9)

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21 Did any subgroups of studies look any different Only control group type/baseline severity had any strong association with effect size Placebo control 0.34 mild/moderate depression 0.49 Level of therapist Non specialist BA 6 studies SMD to 0.43 p< I % Specialist BA 23 studies SMD to 0.54 p< I %

22 How much of BA is needed? Complexity of BA- (self monitoring and scheduling vs. a bit more) Simple BA 19 studies (SMD to 0.51 p< I %) Complex BA in 10 studies (SMD to 0.44 p< I %)

23 What we see/not to much to say really BA is an effective treatment for depression Effect sizes appear consistent as the number of studies slowly grow Subgroup analysis do not show strong association supporting increasing complexity or higher trained therapists We do however need larger studies to provide more definitive examination of this

24 BA compared to CBT Pre COBRA

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27 Consequently NICE (2009) made a clear research recommendation to establish whether behavioural activation is an effective alternative to CBT using a study large enough to determine the presence or absence of clinically important effects using a non-inferiority design (p256).

28 A Randomised Controlled Trial of Behavioural Activation versus Cognitive Therapy for Depression Funded by National Institute of Health Research Health Technology Appraisal

29 Acknowledgements Chief Investigator David Richards Co-investigators David Ekers, Dean McMillan, Sarah Byford, Paul Farrand, Simon Gilbody, Willem Kuyken, Heather O Mahen, Emer O Neill, Rod Taylor, Ed Watkins, Kim Wright Patient and Public Involvement Nigel Reed Trial managers Shelley Rhodes, Emily Fletcher Advisors Steven Hollon, Christopher Martell, Sonia Dimidjian Universities Exeter, Durham, Leeds, Kings College London, Oxford BA, CBT therapists and research workers in Durham/Exeter/Leeds/London

30 COBRA is a two-arm Phase III, non-inferiority randomised controlled trial of a psychological intervention: Behavioural Activation (BA) N=440. The COBRA programme of research seeks to answer two interlinked questions: What is the clinical effectiveness of BA compared to CBT for depressed adults in terms of depression treatment response measured by the PHQ9 at six, 12 and 18 months? What is the cost-effectiveness of BA compared to CBT at 18 months?

31 COBRA Hypotheses BA is non-inferior to CBT (gold standard) for depressed adults in terms of depression treatment response at twelve and 18 months BA is more cost-effective than CBT at 18 months

32 Open accesshttp:// t/article/piis (16) /abstract

33 Summary of Health Economics Costs were lower in the BA group Health utility outcomes (slightly) better, incremental cost-effectiveness ratio (ICER) of - 6,865 from the NHS/PSS perspective. The scatterplot the dominance of BA over CBT, the majority of the scatter points (66%) falling in the south east quadrant of the cost-effectiveness plane where BA is cost-effective compared to CBT (cheaper and more effective).

34 Summary Behavioural Activation for depression is not inferior to CBT and is more cost-effective than CBT against commonly applied decision-maker willingness to pay thresholds. The clinical effects of BA delivered by less experienced mental health workers were identical to those from CBT delivered by accredited CBT therapists.

35 Clinical Implications BA delivered by less experienced mental health workers leads to identical clinical outcomes for patients with depression, but at a financial saving to clinical providers of 21% compared with the costs of providing CBT. This is particularly relevant to the dissemination of effective psychological interventions for depression globally, particularly in low and medium income countries.

36 Implications For many years CBT has been the foremost psychological therapy for depression recommended by therapists, researchers and policy makers alike. Our results raise questions relating to this dominance and we would consequently assert that BA is both a viable and more cost effective alternative to the current situation Behavioural Activation can be delivered by a less experienced, nonprofessionally trained and professionally accredited workforce with no lesser effect than CBT and at less cost. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals.

37 Thank you David Ekers PhD, MSc, ENB 650 (CBT), RMN