Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT
Recruitment status was Not yet recruiting
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First Received Date ICMJE | November 16, 2005 | ||||
Last Updated Date | September 7, 2006 | ||||
Start Date ICMJE | June 2007 | ||||
Primary Completion Date | |||||
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00256464 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT | ||||
Official Title ICMJE | Evaluation of a Multi-Component Yoga Intervention as Adjunct to Psychiatric Treatment for Vietnam Veterans With Posttraumatic Stress Disorder (PTSD): A Randomized Controlled Trial (RCT). | ||||
Brief Summary | The principal aim of this project is to conduct a Randomized Controlled Trial (RCT) to examine whether adding a twelve-session Multi-Component Yoga Intervention (MCYI) to the treatment regimen of Australian Vietnam Veterans suffering chronic Posttraumatic Stress Disorder (PTSD) leads to a significantly greater clinical improvement than conventional psychiatric treatment alone. Include 12 sessions with each session 3 hours duration- 4 days per week for 3 weeks i.e. total of 36 hours. The Multi-Component Yoga Intervention (MCYI) consisting of specific poses, breathing techniques, information about yoga techniques and practices, group processes, psychoeducation, relaxation procedures and meditation techniques in Vietnam War Veterans with chronic Posttraumatic Stress Disorder (PTSD) resistant to treatment has been developed. This project aims to evaluate MCYI through RCT method. 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. |
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Detailed Description | The principal aim of this project is to conduct a Randomized Controlled Trial (RCT) to examine whether adding a twelve-session Multi-Component Yoga Intervention (MCYI) to the treatment regimen of Australian Vietnam Veterans suffering chronic Posttraumatic Stress Disorder (PTSD) leads to a significantly greater clinical improvement than conventional psychiatric treatment alone. Include 12 sessions with each session 3 hours duration- 4 days per week for 3 weeks i.e. total of 36 hours. The Multi-Component Yoga Intervention (MCYI) consisting of specific poses, breathing techniques, information about yoga techniques and practices, group processes, psychoeducation, relaxation procedures and meditation techniques in Vietnam War Veterans with chronic Posttraumatic Stress Disorder (PTSD) resistant to treatment has been developed. This project aims to evaluate MCYI through RCT method. 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Multi-component Yoga Intervention | ||||
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Enrollment ICMJE | 30 | ||||
Completion Date | January 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 50 Years to 70 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT00256464 | ||||
Other Study ID Numbers ICMJE | MCYI-PTSD | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | The University of Queensland | ||||
Collaborators ICMJE | Department of Veterans Affairs | ||||
Investigators ICMJE |
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Information Provided By | The University of Queensland | ||||
Verification Date | August 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |