Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 173
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Rating Scale (HAMD-17)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HAMD-17)
Time Frame: Baseline, 4, 8, 24, 36, 52 week
Secondary Outcomes
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)(Baseline, 8, 24, 36, 52 weeks)
- Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)(Baseline, weeks 1-8, 24, 36, 52 week)
- Short Form Health Survey-36(Baseline, 8, 24, 36, 52 week)
- Clinical Global Improvement Scale (CGI)(Baseline, 8, 24, 36, 52 weeks)
- Work and Social Activity Scale (WSAS)(Baseline, 8, 24,36,52 weeks)