Effectiveness of CBT Augmentation in Major depression treatment: a randomized clinical trial
Phase 3
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-UMIN000001218
- Lead Sponsor
- The E-CAM Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1.No alcohol or substance use disorder in 6 months prior to the screening. 2.No history or concurrent manic or psychotic episode. 3.No other primary DSM-IV Axis I Disorders at screening. 4.No comorbid of antisocial personality disorder. 5.No serious suicidal ideation at screening. 6.Evidence of unable to participate half or more of the intervention phase. 7.No past treatment of CBT. 8.No organic brain lesions or major cognitive deficits in a year prior to the screening. 9.No severe or unstable medical co-morbidities at screening. 10.Other relevant reason decided by the E-CAM investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HAMD-17) change score at 16 week from the baseline will be compared between the groups.
- Secondary Outcome Measures
Name Time Method Response rate (defined as 50% reduction of baseline HAMD-17), remission rate (defined as HAMD-17=<7), subjective depression (measured with the BDI and QIDS/IDS) and quality of life (measured with EQ-5D and SF-36) at 16 week and post-intervention phase (up to 12months) will be compared between the groups. Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups.