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Completed

NCT Number: NCT00290225

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath Water Sound Course and Traumatic Incident Reduction

Behavioral

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Victim Services Center, Miami

Other

Collaborators

  • India: International Association for Human Values
  • National Institute of Mental Health and Neuro Sciences, India
  • The Art of Living Foundation

Registry information

Official study title

Controlled Trial of Yoga Breath Based Group Intervention and Client-Centered Exposure Treatment for Relief of Traumatic Stress and Depression in Tsunami Victims

Important dates

Study start
2005
Study completion
2005
First posted
Feb 10, 2006
Registry last updated
May 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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