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NCT00256477 Clinical Trial

A Controlled Breathing Course for Social & Emotional Health for Vietnam Veterans With Chronic PTSD-RCT

Posttraumatic Stress Disorder Clinical Trial

Official title:
A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans With Chronic Posttraumatic Stress Disorder - A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256477
Other study ID # SKY - PTSD
Secondary ID Ethics approval
Status Completed
Phase Phase 1
First received November 16, 2005
Last updated November 16, 2005
Start date March 2005
Est. completion date October 2005

Study information
Verified date March 2005
Source The University of Queensland
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).

Description:

The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).

This program has been developed by Sri Sri Ravi Shankar, chief yoga teacher and Head of The Art of Living Foundation (Ravishankar 2002). Further, this method has been applied widely for the treatment of Acute Stress Disorder and Posttraumatic Stress Disorder in individual cases (Gerbarg and Brown 2005Direct communication). For example, this controlled breathing program has been reported to have relieved posttraumatic stress disorder (PTSD) in large groups of people affected by mass disasters such as war (Kosovo, Bosnia, Iraq and Sudan) (Biswas 2004; Joseph 2004; Luedemann 2004), terrorism (New York City 9/11) (Anonymous 2001b), (Kashmir, India, Israel) and natural disasters (Gujurat earthquake, 2000) (Anonymous 2001a) Iran flood, Asian Tsunami. This controlled breathing program is reported to have also helped police (Slovenia, India, Washington, DC) and military personnel (Iraq) (cited in Gerbarg and Brown 2004), (Gerbarg 2005Personal communication). Pilot studies conducted by the Principal Investigator using similar techniques showed positive health results for Vietnam Veterans with PTSD in Australia (Carter and Byrne 2004). However, although randomized clinical trials have been performed for depression with good effect

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- suffering chronic post traumatic stress disorder tested by CAPS

- Vietnam Veteran

- Adequate Cognition

Exclusion Criteria:

- Inadequate cogition

- suicidality

- psychosis

- substance abuse other than alcohol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sudarshan KRIYA Breathing Technique

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The University of Queensland

Outcome
Type Measure Description Time frame Safety issue
Primary Reduce the symptoms of PTSD
Primary Reduce the comorbid conditions of Depression and alcohol dependence
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