View Clinical Trial (Medical Research Study)
Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94143 |
| Conditions: |
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Major Depressive Disorder |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00871299 |
| Primary Contact: |
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Principal Investigator
Stuart J Eisendrath, MD
University of California, San Francisco
Stuart J Eisendrath, MD
Phone: 415-476-7868
Email: StuartE@lppi.ucsf.edu
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| Backup Contact: |
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Email: egillung@lppi.ucsf.edu
Erin P Gillung, MA
Phone: 476.7866
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| Location Contact: |
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San Francisco, California 94143
United States
Stuart J Eisendrath, MD
Phone: 415-476-7868
Email: StuartE@lppi.ucsf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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