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Cited by 595Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychotherapy Techniques and ApplicationsDigital Mental Health Interventions

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Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial

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Richards, David A, Ekers, David, McMillan, Dean, Taylor, Rod S, Byford, Sarah, Warren, Fiona C, Barrett, Barbara, Farrand, Paul A, Gilbody, Simon, Kuyken, Willem, O'Mahen, Heather, Watkins, Ed R, Wright, Kim A, Hollon, Steven D, Reed, Nigel, Rhodes, Shelley, Fletcher, Emily, Finning, Katie·2016·The Lancet
DOI 10.1016/s0140-6736(16)31140-0PMC PMC5007415
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Abstract

BACKGROUND: Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. METHODS: In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. FINDINGS: Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed). INTERPRETATION: We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. FUNDING: National Institute for Health Research.

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Figure 1 Trial profile (A) 6 month, (B) 12 month, and (C) 18 month follow-up. BA=behavioural activation. CBT=cognitive behavioural therapy. *Includes four participants who were initially allocated in error and subsequently excluded.
Figure 1 Trial profile (A) 6 month, (B) 12 month, and (C) 18 month follow-up. BA=behavioural activation. CBT=cognitive behavioural therapy. *Includes four participants who were initially allocated in error and subsequently excluded.CC BY · PubMed Central
Figure 2 Bootstrapped mean differences in costs and effects of BA compared with CBT BA=behavioural activation. CBT=cognitive behavioural therapy. NE=northeast. NW=northwest. SE=southeast. SW=southwest. QALY=quality-adjusted life-year.
Figure 2 Bootstrapped mean differences in costs and effects of BA compared with CBT BA=behavioural activation. CBT=cognitive behavioural therapy. NE=northeast. NW=northwest. SE=southeast. SW=southwest. QALY=quality-adjusted life-year.CC BY · PubMed Central

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Authors
Richards, D. A., Ekers, D., McMillan, D., Taylor, R. S., Byford, S., Warren, F. C., Barrett, B., Farrand, P. A., Gilbody, S., Kuyken, W., O'Mahen, H., Watkins, E. R., Wright, K. A., Hollon, S. D., Reed, N., Rhodes, S., Fletcher, E., & Finning, K.
Affiliations
  • University of Exeter (GB)
  • Tees, Esk and Wear Valleys NHS Foundation Trust (GB)
  • University of York (GB)
  • King's College London (GB)
  • Warneford Hospital (GB)
  • Vanderbilt University (US)
Corresponding author
Richards, David A
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2016-08
Volume
388
Issue
10047
Pages
871-880
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(16)31140-0
PMC
PMC5007415
OpenAlex
W2502560620
Cited by
595
References
33
Citations by year
2026: 41 · 2025: 44 · 2024: 59 · 2023: 53 · 2022: 51 · 2021: 92 · 2020: 64 · 2019: 60 · 2018: 69 · 2017: 48 · 2016: 13
FWCI
90.14
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
  • Durham Research Online (Durham University) (acceptedVersion, other-oa)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (submittedVersion)
  • Research Portal (King's College London) (submittedVersion, cc-by)
  • Open Research Exeter (University of Exeter) (submittedVersion, cc-by)
Funders
  • National Institute for Health and Care Research (NF-SI-0514-10037, NF-SI-0611-10203, NF-SI-0514-10155, 10/50/14)
  • European Science Foundation
  • Collaboration for Leadership in Applied Health Research and Care - Greater Manchester
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
Keywords
behavioral activation, cognitive behavioral therapy, depression, major depressive disorder, cost-effectiveness, non-inferiority, PHQ-9, psychotherapy, primary care, treatment safety, depression severity, antidepressant use, remote treatment delivery, hopelessness
MeSH terms
Adult, Aged, Antidepressive Agents, Cost-Benefit Analysis, Depression, Depressive Disorder, Major, Major Depressive Disorder, Direct Service Costs, Educational Status, England, Female, Humans, Male, Middle Aged, Quality of Life, Comorbidity, Cognitive Behavioral Therapy, Linear Models, Treatment Outcome, Quality-Adjusted Life Years, Directive Counseling, Diagnostic and Statistical Manual of Mental Disorders

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