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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871299
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : December 2, 2014
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Health Enhancement Program and medication management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression
Study Start Date : September 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4, 8, 24, 36, 52 week ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871299

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Stuart J Eisendrath, MD University of California, San Francisco

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, San Francisco Identifier: NCT00871299     History of Changes
Obsolete Identifiers: NCT01021254
Other Study ID Numbers: R01 AT004572-O1A1
R01AT004572-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by University of California, San Francisco:
Treatment-resistant depression, meditation, mindfulness

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders