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

This study has been completed.

First Received: February 8, 2006 Last Updated: May 2, 2007 History of Changes

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
Information provided by:	Victim Services Center, Miami
ClinicalTrials.gov Identifier:	NCT00290225

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment
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

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

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

More Information

Additional Information:

Victim Services Center, Miami This link exits the ClinicalTrials.gov site

International Association for Human Values This link exits the ClinicalTrials.gov site

Related research to the BWS intervention This link exits the ClinicalTrials.gov site

Publications:

Brown RP, Gerbarg PL. Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. J Altern Complement Med. 2005 Aug;11(4):711-7. Review.

Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. Review. Erratum in: J Altern Complement Med. 2005 Apr;11(2):383-4.

Study ID Numbers:	VSCIAHVNIMHANS
Study First Received:	February 8, 2006
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00290225 History of Changes
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:

Pathologic Processes
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders

Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009