NCT01058031

Brief Summary

The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

3.2 years

First QC Date

January 26, 2010

Last Update Submit

November 4, 2013

Conditions

Stress Disorders, PosttraumaticPTSD

Outcome Measures

Primary Outcomes (1)

  • PTSD symptom level measured with the CAPS

    3 months

Study Arms (1)

Arm 1

EXPERIMENTAL

MBSR

Behavioral: MBSR

Interventions

MBSRBEHAVIORAL

Mindfulness Based Stress Reduction

Arm 1

Eligibility Criteria

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

You may qualify if:

  • PTSD related to OEF/OIF service

You may not qualify if:

  • History of brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Doug Bremner, MD

    Atlanta VA Medical and Rehab Center, Decatur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 28, 2010

Study Start

January 1, 2007

Primary Completion

April 1, 2010

Study Completion

November 1, 2010

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(1)