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Completed

NCT Number: NCT00871299

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

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.

Health Enhancement Program and medication management

Behavioral

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.

Primary outcomes

  1. Hamilton Depression Rating Scale (HAMD-17)

    Time frame: Baseline, 4, 8, 24, 36, 52 week

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16)

    Time frame: Baseline, weeks 1-8, 24, 36, 52 week

  2. Short Form Health Survey-36

    Time frame: Baseline, 8, 24, 36, 52 week

  3. Clinical Global Improvement Scale (CGI)

    Time frame: Baseline, 8, 24, 36, 52 weeks

  4. Work and Social Activity Scale (WSAS)

    Time frame: Baseline, 8, 24,36,52 weeks

  5. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)

    Time frame: Baseline, 8, 24, 36, 52 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression

Acronym: PATH-D

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2009
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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