Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims
Primary Purpose
Posttraumatic Stress Disorder, Depression
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Breath Water Sound Course and Traumatic Incident Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic stress disorder, depression, disaster mental health, yoga, Breathwork, exposure treatments
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.
Sites / Locations
Outcomes
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.
That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI.
Secondary Outcome Measures
Full Information
NCT ID
NCT00290225
First Posted
February 8, 2006
Last Updated
May 2, 2007
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
1. Study Identification
Unique Protocol Identification Number
NCT00290225
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression
Keywords
Posttraumatic stress disorder, depression, disaster mental health, yoga, Breathwork, exposure treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Breath Water Sound Course and Traumatic Incident Reduction
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedamurthy Achar, Ph.D.
Organizational Affiliation
National Institute of Mental Health and Neurosciences, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa Descilo, MSW
Organizational Affiliation
Victim Services Center, Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R. Damodoran, MA
Organizational Affiliation
International Association for Human Values
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16131297
Citation
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. doi: 10.1089/acm.2005.11.711.
Results Reference
background
PubMed Identifier
15750381
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. doi: 10.1089/acm.2005.11.189. Erratum In: J Altern Complement Med. 2005 Apr;11(2):383-4.
Results Reference
background
Links:
URL
http://www.iahv.org
Description
International Association for Human Values
URL
http://www.aolresearch.org
Description
Related research to the BWS intervention
Learn more about this trial
Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims
We'll reach out to this number within 24 hrs