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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Health Enhancement Program and medication management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00871299

R01AT004572-01A1 (U.S. NIH Grant/Contract)

R01 AT004572-O1A1

3063975

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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173 participants in 2 patient groups

1

Experimental group

Description:

Mindfulness Based Cognitive Therapy (MBCT) + medication management

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

2

Active Comparator group

Description:

The Health Enhancement Program (HEP) + medication management

Treatment:

Behavioral: Health Enhancement Program and medication management