Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-UMIN000050345
- Lead Sponsor
- Keio Universiyt of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1. No comorbid alcohol or substance use disorder in 2 years prior to the screening. 2. No history or concurrent manic or psychotic episode. 3. No other primary DSM-IV Axis I Disorders in 6 months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious and imminent suicidal ideation at screening. 6. No prior experience with previous MBCT program (4 or more sessions) or CBGT program (4 or more sessions). 7. Unlikely to attend more than 4 visits during the 8-week trial phase (eg, due to relocation). 8. No intention of engaging in homework 9. No organic brain lesions or major cognitive deficits in a year prior to the screening. 10. No severe or unstable medical illness at screening. 11. Contraindication to MRI (including cardiac pacemaker, claustrophobia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Group differences in total GRID-Hamilton Depression Rating Scale (HAMD17) scores between MBCT and CBGT groups at post-intervention.
- Secondary Outcome Measures
Name Time Method -Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology -Remission: defined as HAMD-17=<7, QIDS score<5 -Response: defined as 50% reduction of baseline HAMD-17 total score or QIDS score -Anxiety symptoms: Generalized Anxiety Disorder -7 -Anger rumination: Anger Rumination Scale -Automatic thoughts: Automatic Thoughts Questionnaire Revised, -Decentering: Experiences Questionnaire -Mindfulness: Five Facet Mindfulness Questionnaire -Well-being: Satisfaction With Life Scale -Rumination: Ruminative Response Scale -resting state functional connectivity (resting-fMRI)