AzTrials
AzTrials

Posttraumatic Stress DisorderPhase 1NCT00256464

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

A Phase 1 study testing Multi-component Yoga Intervention in people with Posttraumatic Stress Disorder and Depression, run by The University of Queensland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Posttraumatic Stress Disorder, Depression
What is being tested?
Multi-component Yoga Intervention
How many people
30 participants
Where
No sites listed yet
Study dates
Jun 2007to Jan 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Janis J Carter, MBBS FRANZCP contact

61 7 33976425

jjanisca@bigpond.net.au

About this study

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).

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.

Read the 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.

Being tested
Multi-component Yoga Intervention
Keywords
PTSD
Medical subject headings
Stress Disorders, Post-Traumatic, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-component Yoga InterventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decreased symptoms of posttraumatic stress disorder

  2. Decreased symptoms of comorbid conditions of depression and alcohol dependence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2005 (estimated)
  2. Study startJun 2007
  3. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00256464
Sponsor's protocol ID
MCYI-PTSD
Status last verified
Aug 2005
First submitted
16 Nov 2005
Last updated
8 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Multi-component Yoga Intervention in people with Posttraumatic Stress Disorder and Depression, run by The University of Queensland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Janis J Carter, MBBS FRANZCP (61 7 33976425, jjanisca@bigpond.net.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreased symptoms of posttraumatic stress disorder. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in