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Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial

BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Be...

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Autores principales: Rhodes, Shelley, Richards, David A, Ekers, David, McMillan, Dean, Byford, Sarah, Farrand, Paul A, Gilbody, Simon, Hollon, Steven D, Kuyken, Willem, Martell, Christopher, O’Mahen, Heather A, O’Neill, Emer, Reed, Nigel, Taylor, Rod S, Watkins, Ed R, Wright, Kim A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3903024/
https://www.ncbi.nlm.nih.gov/pubmed/24447460
http://dx.doi.org/10.1186/1745-6215-15-29
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author Rhodes, Shelley
Richards, David A
Ekers, David
McMillan, Dean
Byford, Sarah
Farrand, Paul A
Gilbody, Simon
Hollon, Steven D
Kuyken, Willem
Martell, Christopher
O’Mahen, Heather A
O’Neill, Emer
Reed, Nigel
Taylor, Rod S
Watkins, Ed R
Wright, Kim A
author_facet Rhodes, Shelley
Richards, David A
Ekers, David
McMillan, Dean
Byford, Sarah
Farrand, Paul A
Gilbody, Simon
Hollon, Steven D
Kuyken, Willem
Martell, Christopher
O’Mahen, Heather A
O’Neill, Emer
Reed, Nigel
Taylor, Rod S
Watkins, Ed R
Wright, Kim A
author_sort Rhodes, Shelley
collection PubMed
description BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954
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spelling pubmed-39030242014-01-28 Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial Rhodes, Shelley Richards, David A Ekers, David McMillan, Dean Byford, Sarah Farrand, Paul A Gilbody, Simon Hollon, Steven D Kuyken, Willem Martell, Christopher O’Mahen, Heather A O’Neill, Emer Reed, Nigel Taylor, Rod S Watkins, Ed R Wright, Kim A Trials Study Protocol BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954 BioMed Central 2014-01-21 /pmc/articles/PMC3903024/ /pubmed/24447460 http://dx.doi.org/10.1186/1745-6215-15-29 Text en Copyright © 2014 Rhodes et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Rhodes, Shelley
Richards, David A
Ekers, David
McMillan, Dean
Byford, Sarah
Farrand, Paul A
Gilbody, Simon
Hollon, Steven D
Kuyken, Willem
Martell, Christopher
O’Mahen, Heather A
O’Neill, Emer
Reed, Nigel
Taylor, Rod S
Watkins, Ed R
Wright, Kim A
Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title_full Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title_fullStr Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title_full_unstemmed Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title_short Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
title_sort cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (cobra): study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3903024/
https://www.ncbi.nlm.nih.gov/pubmed/24447460
http://dx.doi.org/10.1186/1745-6215-15-29
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