Behavioural Activation for Depression David Ekers PhD, MSc, ENB 650 (CBT), RMN 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 OUR RESEARCH STORY SO FAR 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 Systematic review and Meta-analysis of behavioural treatment for depression Psychological Medicine 2008; 38(5): 611-623. What a meta analysis tells us The combined effect over a number of studies Is there importance variance across findings of studies Is there evidence of important studies missing Generally reports ‘effect size’ as standardised mean difference 0.33-0.55 moderate 0.55 and above large effects 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) Review : Comparison: Outcome: Behavioural A ctivation f or Depression 04 Behavioural vs control 01 SMD all studies BT vs Waitlist/Placebo Control/TAU Study or sub-category N 6 8 7 42 8 6 5 4 15 8 30 19 13 6 22 15 Wilson 1982 (relax) Wilson 1983 Taylor 1977 Mclean 1979 Maldonado Lopez 1982 Wilson 1982 Wilson 1982 (PLA) Wilson 1982 (PLA/re) Cole1983 Skinner 1984 Thompson 1987 Scogin1989 McKendree Smith 1998 Cullen 2006 Dimidjian 2006 Dimidjian 2006 (ls) Behavioural Mean (SD) Wait List Mean (SD) N 12.42(9.38) 7.50(4.55) 10.70(5.00) 9.70(8.00) 7.38(3.74) 12.42(9.38) 11.89(10.87) 11.89(10.87) 26.40(8.00) 14.62(5.90) 12.40(7.80) 9.70(5.70) 12.00(13.15) 3.83(3.31) 16.82(8.56) 15.33(10.03) 10 9 7 43 8 10 12 10 15 9 19 21 14 8 31 19 214 Total (95% CI) Test f or heterogeneity: Chi² = 31.54, df = 15 (P = 0.007), I² = 52.4% Test f or overall ef f ect: Z = 4.50 (P < 0.00001) SMD (random) 95% CI 8.50(6.35) 21.44(5.52) 20.10(5.80) 14.95(8.00) 17.63(8.33) 14.60(9.73) 14.67(11.12) 16.55(10.36) 31.20(8.00) 18.33(4.92) 22.48(7.82) 15.90(6.90) 14.79(9.63) 28.25(16.31) 22.50(12.97) 14.68(7.81) 245 -4 -2 0 Favours Behavioural Review : Comparison: Outcome: Study or sub-category SMD (random) 95% CI 2 0.49 -2.60 -1.63 -0.65 -1.50 -0.21 -0.24 -0.42 -0.58 -0.65 -1.27 -0.96 -0.24 -1.81 -0.49 0.07 [-0.54, [-3.98, [-2.89, [-1.09, [-2.65, [-1.23, [-1.29, [-1.59, [-1.32, [-1.64, [-1.90, [-1.61, [-0.99, [-3.13, [-1.05, [-0.61, 1.52] -1.22] -0.36] -0.21] -0.35] 0.80] 0.81] 0.76] 0.15] 0.33] -0.64] -0.30] 0.52] -0.49] 0.06] 0.75] -0.70 [-1.00, -0.39] 4 Favours control Behavioural Activation f or Depression 06 SMD BT vs CBT 01 BT vs CT Symptom Level N Behavioural Therapy Mean (SD) 01 Symptom Level post Treatment 8 7.50(4.55) Wilson 1983 4 10.70(5.00) Taylor 1977 3 10.70(5.00) Taylor 1977 (CBT) 10 12.62(11.97) Gallaher1982 8 7.38(3.74) Maldonado Lopez 1982 8 16.35(5.37) Maldonado Lopez 1984 8 14.62(5.90) Skinner 1984 5 5.50(3.56) McNamara 1986 5 5.50(3.56) MvNamara 1986 (CBT) 30 12.40(7.80) Thompson 1987 19 9.70(5.70) Scogin1989 28 9.10(7.90) Jacobson 1996 28 9.10(7.90) Jacobson1996 (AT) 13 12.00(13.15) McKendree Smith 1998 16 8.75(7.96) Dimidjian 2006 15 11.00(10.08) Dimidjian 2006 (ls) 208 Subtotal (95% CI) Test f or heterogeneity: Chi² = 19.01, df = 15 (P = 0.21), I² = 21.1% Test f or overall ef f ect: Z = 0.75 (P = 0.46) 02 Symptom level Follow up 9 9.89(9.47) Gallaher1982 14 9.10(6.30) Scogin1989 25 8.50(7.60) Jacobson 1996 25 8.50(7.60) Jacobson1996 (AT) 73 Subtotal (95% CI) Test f or heterogeneity: Chi² = 0.40, df = 3 (P = 0.94), I² = 0% Test f or overall ef f ect: Z = 0.71 (P = 0.47) N Cognitive Therapy Mean (SD) SMD (random) 95% CI SMD (random) 95% CI 8 7 7 10 8 8 7 10 10 31 21 50 43 13 18 17 268 9.00(6.82) 10.30(2.60) 5.60(4.70) 9.71(5.74) 4.88(3.80) 6.37(7.81) 15.00(7.40) 6.50(4.17) 4.80(3.55) 13.60(10.10) 7.50(3.60) 10.10(9.60) 10.60(9.30) 5.62(4.33) 17.44(15.57) 9.76(8.15) -0.24 0.10 0.96 0.30 0.63 1.41 -0.05 -0.24 0.19 -0.13 0.46 -0.11 -0.17 0.63 -0.67 0.13 0.08 [-1.23, 0.74] [-1.13, 1.33] [-0.49, 2.42] [-0.59, 1.18] [-0.38, 1.64] [0.28, 2.54] [-1.07, 0.96] [-1.31, 0.84] [-0.89, 1.26] [-0.63, 0.37] [-0.17, 1.09] [-0.57, 0.35] [-0.65, 0.31] [-0.16, 1.42] [-1.37, 0.02] [-0.56, 0.83] [-0.14, 0.30] 10 15 47 39 111 9.78(5.67) 8.90(6.00) 10.30(8.60) 9.30(8.20) 0.01 0.03 -0.22 -0.10 -0.11 [-0.89, [-0.70, [-0.70, [-0.60, [-0.41, -4 -2 Favours BT 0 2 Favours CT 4 0.91] 0.76] 0.27] 0.40] 0.19] Possible implications of findings BA works compared to control No apparent added benefit of cognitive components BA appears strong in relation to other therapies 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?? (or more meta analysis from the same studies) 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 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 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 Comparison to studies with ‘expert’ therapists Ekers, Dawson and Bailey Journal of Psychiatric and Mental Health Nursing 2013, 20, 186–192 Economic Analysis Ekers D, Godfrey C, Gilbody S, Parrott S, Richards D, Hammond D and Hayes A. (In Press BJ Psych) £2,000 £1,500 Cost more/more effective Cost more/less effective £1,000 Effect Difference £500 -0.15 -0.10 -0.05 £0 0.00 0.05 0.10 -£500 -£1,000 -£1,500 Cost less/less effective Cost less/more effective -£2,000 Cost Difference 0.15 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, Small Study - Big Limitations Small sample 2 therapists No follow up But helped us in looking at the proof of principle 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-dissemination 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 needed to examine results with more therapists and participants CURRENT RESEARCH Behavioural Therapy for depression. A meta-analysis update Ekers, Webster, Cuijpers, Von Straten, Richards, Gilbody 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) Vs. medication results 4 studies, 5 comparisons 288 participants −0.37 (95% CI −0.74 to −0.05 p 0.05 NNT 4.9) Did any subgroups of studies look any different Only control group type had any strong association/placebo controls=reduced effect size Level of therapist Non specialist BA 6 studies SMD −0.66 −0.90 to −0.43 p< 0.001 I2 25.60% Specialist BA 23 studies SMD −0.74 −0.95 to −0.54 p< 0.001 I2 47.27% Complexity of BASimple BA 19 studies (SMD −0.72 −0.92 to −0.51 p< 0.001 I2 58.01%) Complex BA in 10 studies (SMD −0.73 −1.01 to −0.44 p< 0.001 I2 36.49%) What we see 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 COBRA (Cost and Outcome of BehaviouRal Activation) A Randomised Controlled Trial of Behavioural Activation versus Cognitive Therapy for Depression Multi-site Research Team MDC and PCMD, Exeter Richards (CI), Farrand, Kuyken, O’Mahen, Taylor, Watkins, Wright York Gilbody, McMillan Durham Ekers Depression Alliance O’Neill IOP – Byford TSC Tylee DMeC Cape, Lovell CBT Assessors OCTC BA Assessor Martell Advisors Hollon, Martell, Dimidjian Design COBRA is a two-arm Phase III, non-inferiority randomised controlled trial of a psychological intervention: Behavioural Activation (BA). 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 12 and 18 months? We hypothesize that BA is non-inferior compared to CBT in reducing depression severity but that BA will be less costly and thus more costeffective than CBT. In addition, we will undertake a secondary process evaluation to investigate the moderating, mediating and procedural factors in BA and CBT which influence outcome. Interventions BA (Non specialist Band 5) CBT (specialist band 7 therapist) Both active psychological treatments which have previously demonstrated positive effects for people with depression, and are recommended by NICE guidelines for the treatment of depression In both arms of the study, 220 (440 total) participants will receive a maximum of 20 sessions over 16 weeks with the option of four additional booster sessions Sessions will be face to face, of one-hour duration maximum CASPER & CASPER Plus Chief Investigator Prof Simon Gilbody University of York Local Principal Investigator-Site lead Dr David Ekers Funded by NIHR HTA programme What is the effectiveness and cost-effectiveness of brief interventions to prevent the progression of sub-clinical depression in older people?’ CASPER- Sub Threshold Depression- recruitment completed-705 people randomised into Collaborative Care/usual care-recruitment complete CASPER plus- Older adults with depression 450 people to be randomised collaborative care/usual carerecruitment until June 2014 Intervention/follow up Collaborative care, delivered by case manager/own home or over phone 10 sessions Patient engagement & education Co-ordination of care/Medication management Brief psychosocial interventions/Behavioural activation Ensure follow up/Monitor outcomes ‘Stepping-up’ as needed Manual guided intervention – adapted from previous research 12 month follow up of clinical and cost outcomes One of largest RCTs of psychological support for older adults internationally Example how BA may lend itself to collaborative care structures across health settings Summary BA looks to be an effective and simple intervention for depression Its simplicity may make it suitable for wide and efficient dissemination but more research is ongoing Whilst psychotherapies for depression have the same effectiveness the search for improved reach may result in greater clinical/population benefit-this is where BA may have greatest advantage. Behavioural Activation for Depression David Ekers PhD, MSc, ENB 650 (CBT), RMN David.ekers@durham.ac.uk