Clinical trial NCT00290225: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posttraumatic Stress Disorder
Depression
Keywords: Posttraumatic stress disorder
depression
disaster mental health
yoga
Breathwork
exposure treatments
Lead sponsor: Victim Services Center, Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health and Neuro Sciences, India
name: The Art of Living Foundation
name: India: International Association for Human Values
First posted: 2006-02-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms.
timeFrame: improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months
measure: That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI.
timeFrame: Improvement in scores on BDI will occur in one week and persist for 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Mental Health and Neurosciences, India
name: Vedamurthy Achar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Victim Services Center, Miami
name: Teresa Descilo, MSW
role: PRINCIPAL_INVESTIGATOR
affiliation: International Association for Human Values
name: R. Damodoran, MA
role: STUDY_DIRECTOR
References:
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.
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.