Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Mindfulness Based Stress Reduction and Psychoeducation; Behavioral: Psychoeducation

• Registration Number: NCT00998959
• Lead Sponsor: Trina E. Chang, MD

Brief Summary

The purpose of this study is to determine the usefulness of a stress reduction treatment in helping minority patients with major depression get better. Subjects will receive six weeks of either mindfulness-based stress reduction and problem solving therapy or psychoeducation.

Detailed Description

The purpose of this study is to determine the usefulness of a stress reduction treatment compared to psychoeducation in helping minority patients with major depression get better.

The study will last 10 weeks. During the main portion of the study, subjects will receive either individual weekly sessions of stress-reduction therapy or psychoeducation for six weeks. The stress reduction therapy will consist of mindfulness-based stress reduction and problem solving therapy, which focuses on linking psychological problems with psychosocial issues and helping you use your skills and resources to improve your functioning. The psychoeducation will consist of six sessions of education on depression and the treatment and management of symptoms. Each session will last 50 minutes, and four of the visits will also include filling out questionnaires which will take approximately 15-30 minutes to complete. One month after the last session, subjects will come in for a follow-up visit with a study clinician to see how they are doing and to fill out questionnaires.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Meet criteria for current major depressive disorder
• Men or women aged 18-75 who self-identify as a member of a racial or ethnic minority group
• Has a PCP, therapist, psychiatrist, etc aware of their depression. Or, subject agrees to seek outside mental health treatment/management

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness based stress reduction and problem solving therapy	Mindfulness Based Stress Reduction and Psychoeducation	-
Psychoeducation	Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Feasibility (rate of enrollment, attrition)	2 years

Secondary Outcome Measures

Name	Time	Method
Perceived stress	Week 10	We will assess perceived stress at week 10 of subjects' study participation, although we allow for a 12-week period for subjects to complete the study.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States