NCT00290225

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

May 3, 2007

Status Verified

May 1, 2007

First QC Date

February 8, 2006

Last Update Submit

May 2, 2007

Conditions

Keywords

Posttraumatic stress disorderdepressiondisaster mental healthyogaBreathworkexposure treatments

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Drug addiction, notwithstanding alcohol or tobacco.
  • Schizophrenia or other severe pre-existing mental illness
  • Severe physical disability or illness that would prevent study completion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1089/acm.2005.11.711.

    PMID: 16131297BACKGROUND
  • 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.

    PMID: 15750381BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Vedamurthy Achar, Ph.D.

    National Institute of Mental Health and Neurosciences, India

    PRINCIPAL INVESTIGATOR
  • Teresa Descilo, MSW

    Victim Services Center, Miami

    PRINCIPAL INVESTIGATOR
  • R. Damodoran, MA

    International Association for Human Values

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

June 1, 2005

Study Completion

December 1, 2005

Last Updated

May 3, 2007

Record last verified: 2007-05