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

May 2, 2007 updated by: Victim Services Center, Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Improvement in scores on BDI will occur in one week and persist for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

May 3, 2007

Last Update Submitted That Met QC Criteria

May 2, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSCIAHVNIMHANS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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