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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 8, 2006

Last Updated Date

May 2, 2007

Start Date ^†

June 2005

Current 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 ]

Original Primary Outcome Measures ^†

That the BWS course and TIR will provide significant relief from PTSD.
That the BWS course and TIR will provide significant relief from clinical depression.

Change History

Complete list of historical versions of study NCT00290225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment

Condition ^†

Posttraumatic Stress Disorder
Depression

Intervention ^†

Behavioral: Breath Water Sound Course and Traumatic Incident Reduction

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

180

Completion Date

December 2005

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00290225

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Victim Services Center, Miami

Collaborators ^††

National Institute of Mental Health and Neuro Sciences, India
India: 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

Information Provided By

Victim Services Center, Miami

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.