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COBRA : Cost and Outcome of BehaviouRal Activation

COBRA (Cost and Outcome of BehaviouRal Activation): a two-arm Phase III, non-inferiority, patient level, randomised controlled trial of behavioural activation versus cognitive behaviour therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27473954
Enrollment
440
Registered
2011-12-09
Start date
2012-08-01
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

Behavioural Activation (BA): 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,

Sponsors

University of Exeter (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Persons aged 18 and older and over (no upper age limit) with Major Depressive Disorder (DSM) assessed by standard clinical interview [Structured Clinical Interview for Depression (SCID)] 2. Researchers will be trained to administer the SCID using established training and inter-rater reliability procedures that are in use at the Mood Disorders Centre for all the trials

Exclusion criteria

Exclusion criteria: 1. Persons who are alcohol or drug dependent, acutely suicidal or cognitively impaired 2. Have a bipolar disorder or psychosis/psychotic symptoms, ascertained by baseline research interviews 3. People currently in receipt of psychological therapy

Design outcomes

Primary

MeasureTime frame
Self-reported depression severity as measured by the PHQ9 at 12 & 18 months adjusting for baseline outcome values and stratification variables (symptom severity, site, antidepressant use) and fitting therapist as a random effects variable

Secondary

MeasureTime frame
1. Secondary process evaluation to investigate the moderating, mediating and procedural factors in BA and CBT which influence outcome 2. Direct and indirect costs of treatment and disease burden 3. Health-state utility (EQ5D) 4. DSM depression status and depression free days (SCID) 5. Health Related Quality of Life (SF-36) 6. Six month interim analysis on PHQ9

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 21, 2026