Optimizing cognitive behavioral therapy for depression management in psychiatric care study
Not Applicable
Recruiting
- Conditions
- Major depression
- Registration Number
- JPRN-UMIN000043814
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) No alcohol or substance use disorder in 12 months prior to the screening 2) No history or concurrent hypomanic episode, manic episode or psychotic disorders 3) No other primary DSM-IV Axis I Disorders at screening 4) No serious suicidal ideation at screening 5) No organic brain lesions or major cognitive deficits in a year prior to the screening 6) No severe or unstable medical co-morbidities at screening 7) No structured psychotherapy during the intervention 8) Other relevant reason decided by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (defined as 50% reduction of baseline Quick Inventory of Depressive Symptomatology: QIDS) and dropout rate at 16wk
- Secondary Outcome Measures
Name Time Method 1. Baseline reduction score of QIDS at 16,32wks (post randomization) 2. Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), functional disability scale, Client satisfaction questionnaire (CSQ-8j), WHO Health and Work Performance Questionnaire (HPQ): 0,16,32wks 3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session 4. Credibility/ Expectancy Questionnaire (CEQ): 0wk 5. Incremental cost-effectiveness ratio (ICER)