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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
Victim Services Center, Miami
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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

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