Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

Feasibility and Efficacy of a Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction and Psychoeducation; Behavioral: 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness based stress reduction and problem solving therapy	Behavioral: Mindfulness Based Stress Reduction and Psychoeducation; Participants will receive six individual weekly 50-minute sessions of mindfulness based stress reduction (MBSR) as well as problem solving therapy (PST. PST is a type of therapy that focuses on psychosocial problems and using your skills and resources to function better. MBSR uses exercises in mindfulness to reduce stress.
Other: Psychoeducation	Behavioral: Psychoeducation; Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility (rate of enrollment, attrition)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	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.	Week 10

Collaborators and Investigators

• Sponsor: Trina E. Chang, MD
• Collaborators: Dupont-Warren
• Investigators: Principal Investigator: Trina E. Chang, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 20, 2009
• First Posted (Estimate): October 21, 2009

Study Record Updates

• Last Update Posted (Estimate): April 30, 2012
• Last Update Submitted That Met QC Criteria: April 27, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Depression; Major Depression
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2008p001576