Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT
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).
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2007
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedSeptember 8, 2006
August 1, 2005
November 16, 2005
September 7, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Decreased symptoms of posttraumatic stress disorder
Decreased symptoms of comorbid conditions of depression and alcohol dependence
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- US Department of Veterans Affairscollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janis J Carter, MBBS FRANZCP
The University of Queensland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- ECT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 16, 2005
First Posted
November 21, 2005
Study Start
June 1, 2007
Study Completion
January 1, 2008
Last Updated
September 8, 2006
Record last verified: 2005-08