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

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

This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus the Health-Enhancement Program (HEP) for patients with treatment-resistant depression. Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study.

Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. The Health-Enhancement Program (HEP) was developed by researches at the University of Wisconsin, Madison. It has been shown to decrease global stress levels and to increase perceived health which literature has indicated to be contributors to depression. 124 patients with major depressive disorder (MDD)and who have failed to remit from two or more adequate antidepressant trials will be identified and randomized to one of two treatment arms: MBCT+TAU or HEP +TAU. All patients enrolled in the study will undergo research assessments pre and post treatment (baseline and 8-week) and follow-up assessments at months 3,6,9, and 12.

Intervention(s) in this Clinical Trial

• Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
  • MBCT is a group treatment that integrates mindfulness meditation training with some elements of cognitive behavioral therapy (CBT). The program teaches patients how to disengage from habitual, dysfunctional cognitive routines, in particular depression-related ruminative thought patterns.
• Behavioral: Health-Enhancement Program (HEP)
  • 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. HEP 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: Music Therapy, Nutrition, Physical Activity and Functional Movement

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Mindfulness-Based Cognitive Therapy (MBCT) + medication management treatment as usual (TAU)
• Active Comparator: 2
  • The Health-Enhancement Program (HEP) + medication management treatment as usual (TAU)

Primary Measures

• Hamilton Depression Rating Scale (HAMD-17)
  • Time Frame: Baseline, 4,8,24,36,52 week
    Safety Issue?: No

Secondary Measures

• Quick Inventory of Depressive Symptomatology (QIDS-SR16)
  • Time Frame: Baseline, weeks 1-8, 24, 36, 52 week
    Safety Issue?: No
• Short Form Health Survey- 12 (SF-12)
  • Time Frame: Baseline, 8, 24, 36, 52 week
    Safety Issue?: No
• Clinical Global Improvement Scale (CGI)
  • Time Frame: Baseline, 8, 24, 36, 52 weeks
    Safety Issue?: No
• Work and Social Activity Scale (WSAS)
  • Time Frame: Baseline, 8, 24,36,52 weeks
    Safety Issue?: No
• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF)
  • Time Frame: Baseline, 8, 24, 36, 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• DSM-IV Diagnosis of Major Depressive Disorder (MDD)
• Adequate trail of 2 or more antidepressants for a minimum of 6 weeks (one of which is at UCSF)
• Hamilton Depression Rating Scale score of >= 14
• English Speaking
• Not currently in individual or group psychotherapy

Exclusion Criteria:

• Bipolar Disorder
• Obsessive Compulsive Disorder
• Schizophrenia
• Schizoaffective Disorder
• Antisocial Personality Disorder
• Pervasive Developmental Delay
• Major Depression with Psychotic Features

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of California, San Francisco Other

Overall Clinical Trial Officials and Contacts

Stuart J Eisendrath, MD Principal Investigator University of California, San Francisco  

Overall Contact: Erin P Gillung, MA (415) 476-7866 egillung@lppi.ucsf.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01021254

Study ID Number: RO1 AT004572-O1A1

ClinicalTrials.gov Identifier: NCT01021254

Health Authority: United States: Institutional Review Board

UCSF Depression Center