Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT
NCT ID: NCT00256464
Last Updated: 2006-09-08
Study Results
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Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2007-06-30
2008-01-31
Brief Summary
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It is hypothesised that Yoga augmentation will lead to: (1) reduced symptoms of PTSD and Depression; and (2) reduced alcohol intake. A secondary aim of the proposed RCT is to evaluate putative mediating variables. Benefits include that it is low cost and easy to apply. Done at home, non threatening and additional to standard psychiatric treatment for PTSD.
Detailed Description
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It is hypothesised that Yoga augmentation will lead to: (1) reduced symptoms of PTSD and Depression; and (2) reduced alcohol intake. A secondary aim of the proposed RCT is to evaluate putative mediating variables. Benefits include that it is low cost and easy to apply. Done at home, non threatening and additional to standard psychiatric treatment for PTSD.
A comparable method with a different emphasis is currently the subject of a United States grant application by another group to formally test American War Veterans from Afghanistan and Iraq. The chief investigators (Assistant Professor Gerbarg and Associate Professor Brown) are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study utilising a specific Yoga breathing technique called Sudarshan Kriya Yoga (SKY) for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been widely tested on individuals suffering with Acute Stress Disorder and Posttraumatic Stress Disorder (Gerbarg and Brown 2005 Direct communication) and have 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, Iran flood and the Asian Tsunami) (Gujurat earthquake, 2000) (Anonymous 2001a). 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).
(Kessler, Sonnega et al. 1995) studied the disabling effect of PTSD in their NCS study and conclude that PTSD and Major Depression are the two most substantial causes of burden of disease by psychological disorder. The Australian national epidemiology study (Creamer, Burgess et al. 2001) support this in analysis of work days lost per month (2.8 days per month.
Generally, evidence from a well-designed Random Controlled Trial (RCT) is accepted as having a high level of strength for efficacy. From the literature review, none of the outcome studies investigating the efficacy of yoga treatment for PTSD have been conducted by using RCT design. Most of the studies lack treatment control subjects and rely on data from only one program. Thus, it is expected the Multi-Component Yoga Intervention (MCYI) will be the first RCT study conducted internationally and will contribute significantly to the field of mental health and psychiatry.
However, although a randomized clinical trial has been performed for depression with good effect (Janakiramaiah, Gangadhar et al. 2000), there are as yet no randomized clinical trials testing the efficacy of a yoga intervention for Posttraumatic Stress Disorder in Vietnam Veterans. Accordingly, it is proposed to apply a Multi-Component Yoga Intervention (MCYI) for a group of Australian Veterans.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
ECT
SINGLE
Interventions
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Multi-component Yoga Intervention
Eligibility Criteria
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Inclusion Criteria
* Satisfy CAPS test for PTSD having all criterions
* Alcohol Audit with a score of 8 or less in dependence
* An absence of suicidal intent, organic brain disease, absence of present psychosis identified
Exclusion Criteria
* Subject with greater than 20% reduction in their CAPS 2 score between screening and baseline
* Those who are acutely suicidal
* Current substance dependence or abuse exept for alcohol
* Subject requiring electro convulsive therapy or who have had recent ECT which may cause interference with cognitive function.
50 Years
70 Years
MALE
Yes
Sponsors
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US Department of Veterans Affairs
FED
The University of Queensland
OTHER
Principal Investigators
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Janis J Carter, MBBS FRANZCP
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Central Contacts
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Related Links
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History of previous trials
Other Identifiers
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MCYI-PTSD
Identifier Type: -
Identifier Source: org_study_id