Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
|ClinicalTrials.gov Identifier: NCT00998959|
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Mindfulness Based Stress Reduction and Psychoeducation Behavioral: Psychoeducation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Efficacy of a Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
|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.
Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.
- Feasibility (rate of enrollment, attrition) [ Time Frame: 2 years ]
- Perceived stress [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998959
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Trina E. Chang, MD||Massachusetts General Hospital|