Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial.
Trials
; 15: 29, 2014 Jan 21.
Article
in En
| MEDLINE
| ID: mdl-24447460
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Research Design
/
Behavior Therapy
/
Cognitive Behavioral Therapy
/
Health Care Costs
/
Depressive Disorder, Major
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Health_economic_evaluation
/
Qualitative_research
Limits:
Humans
Country/Region as subject:
Europa
Language:
En
Journal:
Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2014
Type:
Article