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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

March 27, 2009
October 28, 2013
September 2009
December 2013   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, 4, 8, 24, 36, 52 week ] [ Designated as safety issue: No ]
Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: 8 Weeks ]
Complete list of historical versions of study NCT00871299 on ClinicalTrials.gov Archive Site
  • 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 ]
Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16) [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Practicing Alternative Techniques to Heal From Depression: The PATH-D Study
Applying Mindfulness-Based Cognitive Therapy to Treatment Resistant Depression

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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.
  • 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.
  • Experimental: 1
    Mindfulness Based Cognitive Therapy (MBCT) + medication management
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • Active Comparator: 2
    The Health Enhancement Program (HEP) + medication management
    Intervention: Behavioral: Health Enhancement Program and medication management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
124
June 2014
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00871299
R01 AT004572-O1A1, R01AT004572-01A1, 3063975
Yes
University of California, San Francisco
University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Stuart J Eisendrath, MD University of California, San Francisco
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP