Feasibility study of manual based cognitive behavioral therapy for depression conducted by mental health specialists in japa
Phase 3
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-UMIN000012106
- Lead Sponsor
- CREC Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
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 psychiatric episode. 3.No other primary DSM-4 Axis1 Disorders at screening. 4.No comorbid of antisocial personality. 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 sever or unstable medical co-morbidities at screening. 10.Other relevant reason decided by the CREC investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale(GRID-HAMD-17) score at 16 week from the baseline will be compared.
- Secondary Outcome Measures
Name Time Method Remission rate (defined as GRID-HAMD-17<7; QIDS<5), response rate (defined as 50% reduction of baseline HAMD-17 and QIDS), subjective depression (measured with the BDI and QIDS), Quality of life (measured with EQ-5D and SF-36) score at 16 week from the baseline will be compared. Dropout rate and adverse events will also be evaluated.