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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00871299
First received: March 27, 2009
Last updated: October 28, 2013
Last verified: October 2013
  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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4, 8, 24, 36, 52 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: June 2014
Estimated Primary Completion Date: December 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871299

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Stuart J Eisendrath, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 28, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2014