Yoga as a Therapy for Traumatic Experiences

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Yoga as an Adjunctive Therapy for Post-Traumatic Stress Disorder: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269490
• Other study ID #: WU# 05-89014
• Secondary ID: DoD Assurance No
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: January 24, 2008
• Start date: December 2005
• Est. completion date: August 2007

Study information

• Verified date: January 2008
• Source: Samueli Institute for Information Biology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Yoga Nidra

Locations

Country	Name	City	State
United States	Deployment Health Clinical Center, Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology	Walter Reed Army Medical Center

Country where clinical trial is conducted

United States,