1. Behavioural Activation for depression by the non specialist David Ekers Nurse Consultant Primary Care Mental Health Clinical Lead Durham and Darlington IAPT

2. Aims for Presentation To introduce BA To Outline results from meta analysis and relate to RCT design Present outcomes of clinical and cost effectiveness Relate to current UK health environment and need for further research

3. Background to BA Uses principles of reinforcement to help understand depression When stable sources of positive reinforcement lost-depression occurs Negative reinforcement and punishment maintain depressed behaviours Therefore goal of BA is to reintroduce diverse and stable sources of positive reinforcement from persons world Views depression not as an internal deficit but based in interaction with environment Largely forgotten in favor of CBT over past 3 decades Potentially simple to deliver effective intervention that would be possibly suited to wider dissemination

4. Systematic review and Meta-analysis of behavioural treatment for depression Ekers D, Richards D, Gilbody S. Psychological Medicine 2008; 38(5): 611-623.

5. Findings BA vs. Control/Usual Care 12 studies (459 participants) Effect size-0.70 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 15.28 (p=0.03) BA vs. CT/CBT Twelve studies (476 patients) No difference effect size at post treatment and follow up (SMD 0.08 95% 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) BA vs. Brief Psychotherapy Three studies (166 patients) BA superior (SMD −0.56, 95% CI −1.0 to −0.12, p= 0.01)

7. Possible implications of findings BA works No added benefit of cognitive components BA appears strong in relation to other therapies

8. Limitations of evidence base No cost analysis Small studies Limited numbers in comparisons beyond BA vs. Control and CBT All ‘experienced therapists’ Does BA’s equivalence maintain with less ‘qualified’ therapists? (more parsimonious as per Jacobson 1996) Simple intervention delivered by ‘expert therapists’ what is active ingredient? No help to improving access to evidenced based therapies if reliant on ‘experts’

9. Pilot Phase II Feasibility RCT. Effectiveness and cost utility of BA for depression delivered by non specialist MH nurses D Ekers D. Richards, S Gilbody, D McMillan & M Bland British Journal of Psychiatry 198: 66-72

10. Method Participants/therapists Recruitment from GPs or PCMH teams Confirmed depression using CSIR (ICD 10) diagnostic tool Exclusion bi-polar disorder, psychosis, organic brain disease, drug and alcohol requiring clinical intervention and suicidal ideation/risk Mental health nurses, no previous psychological therapy training, junior bands (largest MH workforce-need increase in psycho social training) 4 days training -1 day competency assessment as per IAPT 12 session treatment protocol provides a structured approach to intervention. Usual care ‘intervene as you would for someone with this level of problem’ offered therapy at 3 months

11. Measures/quality issues Baseline BDI-II- Work and Social adjustment scale- generic health state (EQ5D)-Client satisfaction questionnaire Measures repeated at 3 months Costs 6 months baseline-3 months during intervention Randomisation by independent agency (list created and held separately from trial team) Assessments blind to allocation/Data entry blind to allocation Independent analysis of adherence to model/protocol by experts in both BA and CBT

12. Statistical methods Covariate analysis using baseline measures to adjust for any possible baseline inconsistency (small trial) Reliable and clinically significant change assessed ITT approach using multiple imputations (100 replications) Based on meta-analysis results with 80% power a sample size of 23 was required in each group

13. Results 68 referrals (41 GP, 27 PCMH) Excluded: diagnosis 17, refused 2, risk 2 Recruited 47 23 BA-24 usual care 7 dropout BA, 2 usual care Final clinical measures 16 BA, 22 usual care High level of baseline severity BDI-II-35.32 (SD 9.50) Long duration 3.67 years (SD 7.2 years) Randomisation produced equal groups

14. Clinical Results BA superior on all measures with large effect and more recovery BDI-II difference post in favour of BA Completers −15.65 (95% CI −6.90 to −24.41) SMD −1.15 (−1.85 to −0.45) ITT−15.78 in favour of BA (95% CI −24.55 to −7.02, p= 0.001) WASA in favour of BA Completers −11.56 (−4.79 to−18.33) p=0.001 SMD −1.14 (−1.84 to −0.45) ITT−11.12 in favour of BA (95% CI −17.53 to −4.70, p= 0.001) Satisfaction BA: 29 on 32 point scale, Better than usual care p=0.001 Strong adherence on checklist

15. Comparison to studies with ‘expert’ therapists

16. Clinical significance 75% of the Behavioural Activation group met the criterion for reliable improvement (improvement of 10 points or more) on the BDI-II vs. 36.4% of the control group (OR = 5.35, 95% CI = 1.3 to 21.9) The treatment group was also more likely to meet criteria for reliable and clinically significant change (56.3% vs. 22.7%; OR = 4.4, 95% CI = 1.1 to 17.8) Response (50% improvement) rates higher in the behavioural activation group (68.2% vs. 18.2%; OR = 9.9, 95% CI = 2.2 to 45.0) Remission rates (BDI-II≤10) higher in BA (56.3% vs. 13.6%; OR = 8.1, 95% CI = 1.7 to 39.1)

17. Economic Analysis David Ekers TEWV-Durham University Christine Godfrey York University Simon Gilbody York University Steve Parrott York University David A. Richards Exeter University Adele Hayes TEWV NHS FT Danielle Hammond TEWV NHS FT

18. Design Cost analysis 6month baseline cost and 3 month intervention period all NHS costs for all participants Health state pre-post using pre a covariate and multiple imputation for missing values EQ5D translated to health state (0=death, 1=perfect health) Costs include training and supervision using nurse consultant QALY used only 3 month gains in calculations Assumption to distribute training costs over anticipated clinical contacts in 3 year period A= all patients treated in year are depression, 65 per year B= 50% of patients treated in year are depression 33 per year

19. Study limitations Small sample 2 therapists (note results of usual care group similar to intervention when given BA by wider number of therapists) No follow up

20. Summary BA for some time has been viewed as an effective intervention (as effective as CBT) Results appear to maintain when delivered by non specialists with appt training (parsimony as per Jacobson 1996) Cost effectiveness appears very promising with BA offering well below NICE threshold cost per QALY even using conservative estimate Large scale replication is needed to examine results with more therapists and participants

21. contact David.ekers@tewv.nhs.uk Thank you