Posttraumatic Stress DisorderPhase 1NCT00256477
A Controlled Breathing Course for Social & Emotional Health for Vietnam Veterans With Chronic PTSD-RCT
A Phase 1 study testing Sudarshan KRIYA Breathing Technique in people with Posttraumatic Stress Disorder, run by The University of Queensland.
Trial summary
The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. 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
- What is being tested?
- Sudarshan KRIYA Breathing Technique
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Oct 2005
- 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
- suffering chronic post traumatic stress disorder tested by CAPS
- Vietnam Veteran
- Adequate Cognition
Who cannot join
- Inadequate cogition
- suicidality
- psychosis
- substance abuse other than alcohol
About this study
Official title: A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans With Chronic Posttraumatic Stress Disorder - A Randomised Controlled Trial
The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).
Read the detailed description
The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).
This program has been developed by Sri Sri Ravi Shankar, chief yoga teacher and Head of The Art of Living Foundation (Ravishankar 2002). Further, this method has been applied widely for the treatment of Acute Stress Disorder and Posttraumatic Stress Disorder in individual cases (Gerbarg and Brown 2005Direct communication). For example, this controlled breathing program has 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, 2000) (Anonymous 2001a) Iran flood, Asian Tsunami. This controlled breathing program is reported to have also helped police (Slovenia, India, Washington, DC) and military personnel (Iraq) (cited in Gerbarg and Brown 2004), (Gerbarg 2005Personal communication). 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). However, although randomized clinical trials have been performed for depression with good effect
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Sudarshan KRIYA Breathing Technique
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudarshan KRIYA Breathing TechniqueBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the symptoms of PTSD
Reduce the 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.
- First posted21 Nov 2005 (estimated)
- Study startMar 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Investigators
- Dr Janis J CARTER, MBBS FRANZCP, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256477
- Sponsor's protocol ID
- SKY - PTSD
- Other IDs
- Ethics approval 2005000320
- Status last verified
- Mar 2005
- First submitted
- 16 Nov 2005
- Last updated
- 21 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans With Chronic Posttraumatic Stress Disorder - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00256477
- Acronym / sponsor ID
- SKY - PTSD
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Oct 2005
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).
Detailed description
The main aim of this project is to evaluate the use of a specific Yoga technique of controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This method is currently the subject of a United States grant application to formally test American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this course for treatment of American veterans returning from Afghanistan and Iraq. Elements of this method have been used on a variety of populations. Whilst this is a multi-component intervention, it is postulated that the most active ingredient in the program is a specific Yoga breathing technique called Sudarshan Kriya (SK).
This program has been developed by Sri Sri Ravi Shankar, chief yoga teacher and Head of The Art of Living Foundation (Ravishankar 2002). Further, this method has been applied widely for the treatment of Acute Stress Disorder and Posttraumatic Stress Disorder in individual cases (Gerbarg and Brown 2005Direct communication). For example, this controlled breathing program has 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, 2000) (Anonymous 2001a) Iran flood, Asian Tsunami. This controlled breathing program is reported to have also helped police (Slovenia, India, Washington, DC) and military personnel (Iraq) (cited in Gerbarg and Brown 2004), (Gerbarg 2005Personal communication). 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). However, although randomized clinical trials have been performed for depression with good effect
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suffering chronic post traumatic stress disorder tested by CAPS
- Vietnam Veteran
- Adequate Cognition
Key exclusion criteria (4 listed)
- Inadequate cogition
- suicidality
- psychosis
- substance abuse other than alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sudarshan KRIYA Breathing Technique | Behavioural | – |
Primary outcome
Reduce the symptoms of PTSD
Reduce the comorbid conditions of Depression and alcohol dependence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2005.
- History of Trials thus farLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Janis J CARTER, MBBS FRANZCP principal investigator
The University of Queensland
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sudarshan KRIYA Breathing Technique in people with Posttraumatic Stress Disorder, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2005. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce the symptoms of PTSD. 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 21 Nov 2005.