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Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

This study has been completed.
Sponsor:
Collaborator:
Dupont-Warren
Information provided by (Responsible Party):
Trina E. Chang, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00998959
First received: October 15, 2009
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Major Depressive Disorder
 Behavioral: Mindfulness Based Stress Reduction and Psychoeducation
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of a Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasibility (rate of enrollment, attrition) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived stress [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998959

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Trina E. Chang, MD
Dupont-Warren
Investigators
Principal Investigator: Trina E. Chang, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Trina E. Chang, MD, Staff Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00998959     History of Changes
Other Study ID Numbers: 2008p001576
Study First Received: October 15, 2009
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Depression
Major Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013