Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 27, 2009 | ||||||||
| Last Updated Date | May 16, 2013 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4, 8, 24, 36, 52 week ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: 8 Weeks ] | ||||||||
| Change History | Complete list of historical versions of study NCT00871299 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16) [ Time Frame: 8 weeks ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Practicing Alternative Techniques to Heal From Depression: The PATH-D Study | ||||||||
| Official Title ICMJE | Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 124 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00871299 | ||||||||
| Other Study ID Numbers ICMJE | R01 AT004572-O1A1, R01AT004572-01A1, 3063975 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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