Posttraumatic Stress DisorderPhase 3NCT00290225
Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims
A Phase 3 study testing Breath Water Sound Course and Traumatic Incident Reduction in people with Posttraumatic Stress Disorder and Depression, run by Victim Services Center, Miami.
Trial summary
Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide additional, significant relief of PTSD and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Breath Water Sound Course and Traumatic Incident Reduction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2005
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tsunami witness, tsunami victim, and/or lost loved one or property.
- Ages 18-70
- Willing to participate for the entire length of this research study.
Who cannot join
- Drug addiction, notwithstanding alcohol or tobacco.
- Schizophrenia or other severe pre-existing mental illness
- Severe physical disability or illness that would prevent study completion.
About this study
Official title: Controlled Trial of Yoga Breath Based Group Intervention and Client-Centered Exposure Treatment for Relief of Traumatic Stress and Depression in Tsunami Victims
Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide additional, significant relief of PTSD and depression in tsunami victims.
180 tsunami victims in Southern India will be divided into three groups: those that only receive BWS course, those that receive the BWS course and TIR and a wait-list control. They will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General Health Questionaire. These scales will also be administered post-service as well as five weeks post pre-testing and at three and six month intervals.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Breath Water Sound Course and Traumatic Incident Reduction
- Keywords
- Posttraumatic stress disorder, depression, disaster mental health, yoga, Breathwork, exposure treatments
- 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.
Breath Water Sound Course and Traumatic Incident ReductionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms.
Measured: improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months
That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI.
Measured: Improvement in scores on BDI will occur in one week and persist for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJun 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victim Services Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, The Art of Living Foundation, India: International Association for Human Values
- Investigators
- Vedamurthy Achar, Ph.D., Principal investigator, National Institute of Mental Health and Neurosciences, IndiaTeresa Descilo, MSW, Principal investigator, Victim Services Center, MiamiR. Damodoran, MA, Study director, International Association for Human Values
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290225
- Sponsor's protocol ID
- VSCIAHVNIMHANS
- Status last verified
- May 2007
- First submitted
- 8 Feb 2006
- Last updated
- 3 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown RP, Gerbarg PL. Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. J Altern Complement Med. 2005 Aug;11(4):711-7. doi: 10.1089/acm.2005.11.711.
PubMed 16131297Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.
PubMed 15750381
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of Yoga Breath Based Group Intervention and Client-Centered Exposure Treatment for Relief of Traumatic Stress and Depression in Tsunami Victims
- ClinicalTrials.gov ID
- NCT00290225
- Acronym / sponsor ID
- VSCIAHVNIMHANS
- Conditions
- Posttraumatic Stress Disorder, Depression
- Keywords
- Posttraumatic stress disorder, depression, disaster mental health, yoga, Breathwork, exposure treatments
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Victim Services Center, MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, The Art of Living Foundation, India: International Association for Human Values
- Study start
- Jun 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 10 Feb 2006 (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.
Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide additional, significant relief of PTSD and depression in tsunami victims.
180 tsunami victims in Southern India will be divided into three groups: those that only receive BWS course, those that receive the BWS course and TIR and a wait-list control. They will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General Health Questionaire. These scales will also be administered post-service as well as five weeks post pre-testing and at three and six month intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tsunami witness, tsunami victim, and/or lost loved one or property.
- Ages 18-70
- Willing to participate for the entire length of this research study.
Key exclusion criteria (3 listed)
- Drug addiction, notwithstanding alcohol or tobacco.
- Schizophrenia or other severe pre-existing mental illness
- Severe physical disability or illness that would prevent study completion.
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 |
|---|---|---|
| Breath Water Sound Course and Traumatic Incident Reduction | Behavioural | – |
Primary outcome
That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms.
Time frame: improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months
That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI.
Time frame: Improvement in scores on BDI will occur in one week and persist for 6 months
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 3 May 2007.
- Background: PubMed 16131297Brown RP, Gerbarg PL. Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. J Altern Complement Med. 2005 Aug;11(4):711-7. doi: 10.1089/acm.2005.11.711.
- Background: PubMed 15750381Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.
- International Association for Human ValuesLink provided by the sponsor.
- Related research to the BWS interventionLink 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.
Vedamurthy Achar, Ph.D. principal investigator
National Institute of Mental Health and Neurosciences, India
Teresa Descilo, MSW principal investigator
Victim Services Center, Miami
R. Damodoran, MA study director
International Association for Human Values
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breath Water Sound Course and Traumatic Incident Reduction in people with Posttraumatic Stress Disorder and Depression, run by Victim Services Center, Miami.
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 3 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 3 May 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms. (time frame: improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months). 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?
On the ClinicalTrials.gov record for NCT00290225, which also lists 2 linked publications.
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 3 May 2007.