Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder |
Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Health Enhancement Program and medication management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression |
- Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4, 8, 24, 36, 52 week ] [ Designated as safety issue: No ]
- Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16) [ Time Frame: Baseline, weeks 1-8, 24, 36, 52 week ] [ Designated as safety issue: No ]
- Short Form Health Survey-36 [ Time Frame: Baseline, 8, 24, 36, 52 week ] [ Designated as safety issue: No ]
- Clinical Global Improvement Scale (CGI) [ Time Frame: Baseline, 8, 24, 36, 52 weeks ] [ Designated as safety issue: No ]
- Work and Social Activity Scale (WSAS) [ Time Frame: Baseline, 8, 24,36,52 weeks ] [ Designated as safety issue: No ]
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF) [ Time Frame: Baseline, 8, 24, 36, 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Mindfulness Based Cognitive Therapy (MBCT) + medication management
|
Behavioral: Mindfulness Based Cognitive Therapy
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.
|
|
Active Comparator: 2
The Health Enhancement Program (HEP) + medication management
|
Behavioral: Health Enhancement Program and medication management
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Stuart J Eisendrath, MD | 415-476-7868 | StuartE@lppi.ucsf.edu |
| Contact: Erin P Gillung, MA | 476.7866 | egillung@lppi.ucsf.edu |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Stuart J Eisendrath, MD 415-476-7868 StuartE@lppi.ucsf.edu | |
| Contact: Erin P Gillung, MA 415-476-7886 egillung@lppi.ucsf.edu | |
| Principal Investigator: Stuart J Eisendrath, MD | |
| Principal Investigator: | Stuart J Eisendrath, MD | University of California, San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00871299 History of Changes |
| Obsolete Identifiers: | NCT01021254 |
| Other Study ID Numbers: | R01 AT004572-O1A1, R01AT004572-01A1, 3063975 |
| Study First Received: | March 27, 2009 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
Treatment Resistant |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013