Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction and Psychoeducation
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depression
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mindfulness based stress reduction and problem solving therapy
Psychoeducation
Arm Description
Outcomes
Primary Outcome Measures
Feasibility (rate of enrollment, attrition)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00998959
First Posted
October 15, 2009
Last Updated
April 27, 2012
Sponsor
Trina E. Chang, MD
Collaborators
Dupont-Warren
1. Study Identification
Unique Protocol Identification Number
NCT00998959
Brief Title
Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
Official Title
Feasibility and Efficacy of a Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trina E. Chang, MD
Collaborators
Dupont-Warren
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based stress reduction and problem solving therapy
Arm Type
Experimental
Arm Title
Psychoeducation
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction and Psychoeducation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.
Primary Outcome Measure Information:
Title
Feasibility (rate of enrollment, attrition)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Perceived stress
Description
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.
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trina E. Chang, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
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