Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256464
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2005-11-16
Brief Title:
Evaluation of a MCYI as Adjunct to Psychiatric Treatment for Vietnam Veterans With PTSD - RCT
Sponsor:
The University of Queensland
Organization:
The University of Queensland
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 911 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 28 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
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 911 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 28 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None