Practicing Alternative Techniques to Heal From Depression: The PATH-D Study

Study Overview
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Brief Summary
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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.

Official Title
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Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Mindfulness Based Cognitive Therapy
* Behavioral: Health Enhancement Program and medication management


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mindfulness Based Cognitive Therapy (MBCT) + medication management | Behavioral: Mindfulness Based Cognitive Therapy<br>* 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.<br>|
| Active Comparator: 2<br>The Health Enhancement Program (HEP) + medication management | Behavioral: Health Enhancement Program and medication management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD-17) |  | Baseline, 4, 8, 24, 36, 52 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF) |  | Baseline, 8, 24, 36, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment-resistant depression, meditation, mindfulness