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Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims

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ClinicalTrials.gov Identifier: NCT00290225
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : May 3, 2007
Sponsor:
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

Brief 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 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 or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Depression Behavioral: Breath Water Sound Course and Traumatic Incident Reduction Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Tsunami witness, tsunami victim, and/or lost loved one or property.
  2. Ages 18-70
  3. Willing to participate for the entire length of this research study.

Exclusion Criteria:

  1. Drug addiction, notwithstanding alcohol or tobacco.
  2. Schizophrenia or other severe pre-existing mental illness
  3. Severe physical disability or illness that would prevent study completion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00290225     History of Changes
Other Study ID Numbers: VSCIAHVNIMHANS
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007

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, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders