Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims
This study has been completed.
Sponsor:
Victim Services Center, Miami
Collaborators:
National Institute of Mental Health and Neuro Sciences, India
The Art of Living Foundation
India: International Association for Human Values
Information provided by:
Victim Services Center, Miami
ClinicalTrials.gov Identifier:
NCT00290225
First received: February 8, 2006
Last updated: May 2, 2007
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorder Depression |
Behavioral: Breath Water Sound Course and Traumatic Incident Reduction |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drinking Water
Mental Health
Post-Traumatic Stress Disorder
Tsunamis
U.S. FDA Resources
Further study details as provided by Victim Services Center, Miami:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 180 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Drug addiction, notwithstanding alcohol or tobacco.
- Schizophrenia or other severe pre-existing mental illness
- Severe physical disability or illness that would prevent study completion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290225
Sponsors and Collaborators
Victim Services Center, Miami
National Institute of Mental Health and Neuro Sciences, India
The Art of Living Foundation
India: International Association for Human Values
Investigators
| Principal Investigator: | Vedamurthy Achar, Ph.D. | National Institute of Mental Health and Neurosciences, India |
| Principal Investigator: | Teresa Descilo, MSW | Victim Services Center, Miami |
| Study Director: | R. Damodoran, MA | International Association for Human Values |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00290225 History of Changes |
| Other Study ID Numbers: | VSCIAHVNIMHANS |
| Study First Received: | February 8, 2006 |
| Last Updated: | May 2, 2007 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Victim Services Center, Miami:
|
Posttraumatic stress disorder depression disaster mental health |
yoga Breathwork exposure treatments |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |
Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on June 18, 2013