NCT00269490

Brief Summary

The purpose of the proposed research is to conduct a feasibility study of yoga as an adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will complete 10 weeks of yoga training, in addition to the continuing their usual and customary care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep relaxation, deep breathing and meditation to systematically reduce physical, emotional, mental, and even subconscious tension. After a diagnostic mental health assessment at baseline, participants will attend a total of 18 classes taught over a 10-week period and will practice daily at home using a compact disk provided by the instructor. Baseline measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and pain will be assessed over the course of the study. An additional goal of this study is to gather preliminary data on the anticipated effect size and feasibility of conducting a larger clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted military personnel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2005

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

December 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

Enrollment Period

10 months

First QC Date

December 21, 2005

Last Update Submit

January 24, 2008

Conditions

Keywords

Post-Traumatic Stress DisorderYoga Nidra

Interventions

Yoga NidraBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Active Duty military personnel
  • Aged 18 and over
  • A minimum score of 40 on the Posttraumatic Stress Disorder Checklist (PCL-M), a brief, self-report instrument used to assess PTSD severity.

You may not qualify if:

  • Active suicidal or homicidal ideation
  • Severe cognitive impairment or history of cognitive disorder
  • Serious surgical procedures within the last two months or planned
  • Treatment for refractory pain
  • New or dose adjusted psychotropic medication (i.e. SSRIs and anxiolytics) in last month
  • Unwilling or unable to practice Yoga Nidra at home
  • Amputation of any body part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deployment Health Clinical Center, Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-8064, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • COL Charles C Engel, MD, MPA

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR
  • Christine Goertz Choate, DC, PhD

    Samueli Institute for Information Biology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

December 1, 2005

Primary Completion

October 1, 2006

Study Completion

August 1, 2007

Last Updated

January 28, 2008

Record last verified: 2008-01

Locations