NCT00998959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

3.4 years

First QC Date

October 15, 2009

Last Update Submit

April 27, 2012

Conditions

Keywords

DepressionMajor Depression

Outcome Measures

Primary Outcomes (1)

  • Feasibility (rate of enrollment, attrition)

    2 years

Secondary Outcomes (1)

  • Perceived stress

    Week 10

Study Arms (2)

Mindfulness based stress reduction and problem solving therapy

EXPERIMENTAL
Behavioral: Mindfulness Based Stress Reduction and Psychoeducation

Psychoeducation

OTHER
Behavioral: Psychoeducation

Interventions

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.

Mindfulness based stress reduction and problem solving therapy
PsychoeducationBEHAVIORAL

Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.

Psychoeducation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Trina E. Chang, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 21, 2009

Study Start

August 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations