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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00290225
First received: February 8, 2006
Last updated: May 2, 2007
Last verified: May 2007
  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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014