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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290225
• Other study ID #: VSCIAHVNIMHANS
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2006
• Last updated: May 2, 2007
• Start date: June 2005
• Est. completion date: December 2005

Study information

• Verified date: May 2007
• Source: Victim Services Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Breath Water Sound Course and Traumatic Incident Reduction

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Victim Services Center, Miami	India: International Association for Human Values, National Institute of Mental Health and Neuro Sciences, India, The Art of Living Foundation

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms.		improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months
Primary	That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI.		Improvement in scores on BDI will occur in one week and persist for 6 months

External Links

•   International Association for Human Values
•   Related research to the BWS intervention
•   Victim Services Center, Miami