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Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT

Primary Purpose

Posttraumatic Stress Disorder, Depression

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Multi-component Yoga Intervention
Sponsored by
The University of Queensland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Symptoms of PTSD DSM IV for a minimum of 12 months prior to screening meeting Mini Plus 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: History of psychosis 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Decreased symptoms of posttraumatic stress disorder
    Decreased symptoms of comorbid conditions of depression and alcohol dependence

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2005
    Last Updated
    September 7, 2006
    Sponsor
    The University of Queensland
    Collaborators
    US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00256464
    Brief Title
    Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT
    Official Title
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The University of Queensland
    Collaborators
    US Department of Veterans Affairs

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorder, Depression
    Keywords
    PTSD

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Multi-component Yoga Intervention
    Primary Outcome Measure Information:
    Title
    Decreased symptoms of posttraumatic stress disorder
    Title
    Decreased symptoms of comorbid conditions of depression and alcohol dependence

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Symptoms of PTSD DSM IV for a minimum of 12 months prior to screening meeting Mini Plus 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: History of psychosis 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Janis J Carter, MBBS FRANZCP
    Phone
    61 7 33976425
    Email
    jjanisca@bigpond.net.au
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janis J Carter, MBBS FRANZCP
    Organizational Affiliation
    The University of Queensland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.therapywithyoga.com
    Description
    History of previous trials

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    Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT

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