An interventional study of Mindfulness Based Cognitive Therapy and Health Enhancement Program and medication management in Major Depressive Disorder, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus Health-Enhancement Program (HEP) for patients with treatment-resistant major depressive disorder (MDD). Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. MBCT is a new technique that has been found to be effective for prevention of relapse in individuals in complete recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. This study will use an active condition called the Health Enhancement Program (HEP) which was specifically developed to serve as a comparison condition for mindfulness interventions. HEP has been shown to decrease global stress levels and to increase perceived health. Stress has been considered a contributor to depression. One hundred and seventy four patients with MDD who have failed two or more adequate antidepressant trials will be identified and randomly assigned to one of two groups: MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans immediately before and after treatment to better understand the neural pathways implicated in depression and those that may be affected through treatment.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 173 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DSM-IV TR Diagnosis of Major Depression receiving medication management.
Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF).
Hamilton Depression Rating Scale 17 score ≥ 14
Any Ethnicity
English Speaking
Male or Female
No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP
Exclusion Criteria:
Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features
Active Suicidality (per HAM-D17 > 1 on item 3)
Meditation Practice once or more per week; yoga more than twice per week at study entry
Substance Abuse Disorder within 6 months
Cognitive Disorder with Mini Mental Status Exam score \< 25
Medical illness rated 4 on Cumulative Illness Rating Scale
Mindfulness Based Cognitive Therapy (MBCT) + medication management
Behavioral: Mindfulness Based Cognitive Therapy
The Health Enhancement Program (HEP) + medication management
Behavioral: Health Enhancement Program and medication management
Mindfulness-Based Cognitive Therapy (MBCT) is a group treatment that integrates mindfulness meditation training with some CBT concepts and was specifically developed as a relapse prevention intervention for MDD. The program teaches skills that allow patients to disengage from habitual ("automatic") dysfunctional cognitive routines, in particular depression-related ruminative thought patterns, as a way to reduce future risk of relapse and recurrence of depression.
The Health Enhancement Program (HEP)was developed at the University of Wisconsin, Madison and is modeled after traditional activity and nutrition programs used in weight management- cardiac rehab and diabetes prevention programs. The program is designed to increase overall health and well-being by focusing on four health domains that impact health and are interventions regularly practiced at integrative medicine. These include: (I) Music Therapy (2) Nutrition (3) physical activity including, walking and stretching and (4) Functional movement.
Hamilton Depression Rating Scale (HAMD-17)
Time frame: Baseline, 4, 8, 24, 36, 52 week
Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)
Time frame: Baseline, weeks 1-8, 24, 36, 52 week
Short Form Health Survey-36
Time frame: Baseline, 8, 24, 36, 52 week
Clinical Global Improvement Scale (CGI)
Time frame: Baseline, 8, 24, 36, 52 weeks
Work and Social Activity Scale (WSAS)
Time frame: Baseline, 8, 24,36,52 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)
Time frame: Baseline, 8, 24, 36, 52 weeks
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco