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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Health Enhancement Program and medication management

• Registration Number: NCT00871299
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mindfulness Based Cognitive Therapy	Mindfulness Based Cognitive Therapy (MBCT) + medication management
2	Health Enhancement Program and medication management	The Health Enhancement Program (HEP) + medication management

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD-17)	Baseline, 4, 8, 24, 36, 52 week

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States