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dc.contributor.authorRichards, DA
dc.contributor.authorRhodes, S
dc.contributor.authorEkers, D
dc.contributor.authorMcMillan, D
dc.contributor.authorTaylor, RS
dc.contributor.authorByford, S
dc.contributor.authorBarrett, B
dc.contributor.authorFinning, K
dc.contributor.authorGanguli, P
dc.contributor.authorWarren, F
dc.contributor.authorFarrand, P
dc.contributor.authorGilbody, S
dc.contributor.authorKuyken, W
dc.contributor.authorO'Mahen, H
dc.contributor.authorWatkins, E
dc.contributor.authorWright, K
dc.contributor.authorReed, N
dc.contributor.authorFletcher, E
dc.contributor.authorHollon, SD
dc.contributor.authorMoore, L
dc.contributor.authorBackhouse, A
dc.contributor.authorFarrow, C
dc.contributor.authorGarry, J
dc.contributor.authorKemp, D
dc.contributor.authorPlummer, F
dc.contributor.authorWarner, F
dc.contributor.authorWoodhouse, R
dc.date.accessioned2018-02-26T14:55:23Z
dc.date.issued2017-08
dc.description.abstractBACKGROUND: Depression is a common, debilitating and costly disorder. The best-evidenced psychological therapy - cognitive-behavioural therapy (CBT) - is complex and costly. A simpler therapy, behavioural activation (BA), may be an effective alternative. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of BA compared with CBT for depressed adults at 12 and 18 months' follow-up, and to investigate the processes of treatments. DESIGN: Randomised controlled, non-inferiority trial stratified by depression severity, antidepressant use and recruitment site, with embedded process evaluation; and randomisation by remote computer-generated allocation. SETTING: Three community mental health services in England. PARTICIPANTS: Adults aged ≥ 18 years with major depressive disorder (MDD) recruited from primary care and psychological therapy services. INTERVENTIONS: BA delivered by NHS junior mental health workers (MHWs); CBT by NHS psychological therapists. OUTCOMES: Primary: depression severity (as measured via the Patient Health Questionnaire-9; PHQ-9) at 12 months. Secondary: MDD status; number of depression-free days; anxiety (as measured via the Generalised Anxiety Disorder-7); health-related quality of life (as measured via the Short Form questionnaire-36 items) at 6, 12 and 18 months; and PHQ-9 at 6 and 18 months, all collected by assessors blinded to treatment allocation. Non-inferiority margin was 1.9 PHQ-9 points. We undertook intention-to-treat (ITT) and per protocol (PP) analyses. We explored cost-effectiveness by collecting direct treatment and other health- and social-care costs and calculating quality-adjusted life-years (QALYs) using the EuroQol-5 Dimensions, three-level version, at 18 months. RESULTS: We recruited 440 participants (BA, n = 221; CBT, n = 219); 175 (79%) BA and 189 (86%) CBT participants provided ITT data and 135 (61%) BA and 151 (69%) CBT participants provided PP data. At 12 months we found that BA was non-inferior to CBT {ITT: CBT 8.4 PHQ-9 points [standard deviation (SD) 7.5 PHQ-9 points], BA 8.4 PHQ-9 points (SD 7.0 PHQ-9 points), mean difference 0.1 PHQ-9 points, 95% confidence interval (CI) -1.3 to 1.5 PHQ-9 points, p = 0.89; PP: CBT 7.9 PHQ-9 points (SD 7.3 PHQ-9 points), BA 7.8 PHQ-9 points (SD 6.5 PHQ-9 points), mean difference 0.0 PHQ-9 points, 95% CI -1.5 to 1.6 PHQ-9 points, p = 0.99}. We found no differences in secondary outcomes. We found a significant difference in mean intervention costs (BA, £975; CBT, £1235; p < 0.001), but no differences in non-intervention (hospital, community health, social care and medication costs) or total (non-intervention plus intervention) costs. Costs were lower and QALY outcomes better in the BA group, generating an incremental cost-effectiveness ratio of -£6865. The probability of BA being cost-effective compared with CBT was almost 80% at the National Institute for Health and Care Excellence's preferred willingness-to-pay threshold of £20,000-30,000 per QALY. There were no trial-related adverse events. LIMITATIONS: In this pragmatic trial many depressed participants in both groups were also taking antidepressant medication, although most had been doing so for a considerable time before entering the trial. Around one-third of participants chose not to complete a PP dose of treatment, a finding common in both psychotherapy trials and routine practice. CONCLUSIONS: We found that BA is as effective as CBT, more cost-effective and can be delivered by MHWs with no professional training in psychological therapies. FUTURE WORK: Settings and countries with a paucity of professionally qualified psychological therapists, might choose to investigate the delivery of effective psychological therapy for depression without the need to develop an extensive and costly professional infrastructure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 46. See the NIHR Journals Library website for further project information.en_GB
dc.description.sponsorshipThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme.en_GB
dc.identifier.citationVol 21 (46)en_GB
dc.identifier.doi10.3310/hta21460
dc.identifier.urihttp://hdl.handle.net/10871/31712
dc.language.isoenen_GB
dc.publisherNIHR Health Technology Assessment Programmeen_GB
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pubmed/28857042en_GB
dc.rights© Queen’s Printer and Controller of HMSO 2017. This work was produced by Richards et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UKen_GB
dc.titleCost and Outcome of BehaviouRal Activation (COBRA): a randomised controlled trial of behavioural activation versus cognitive-behavioural therapy for depressionen_GB
dc.typeArticleen_GB
dc.date.available2018-02-26T14:55:23Z
dc.identifier.issn1366-5278
exeter.place-of-publicationEnglanden_GB
dc.descriptionThis is the final version of the article. Available from the publisher via the DOI in this record.en_GB
dc.identifier.journalHealth Technology Assessmenten_GB


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