Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier:
NCT00136357
First received: August 26, 2005
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.


Condition Intervention
Stress Disorders, Post-traumatic
Behavioral: Mind-Body Skills Groups

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Center for Mind-Body Medicine:

Primary Outcome Measures:
  • Harvard Trauma Questionnaire [ Time Frame: Baseline, 12 weeks, 3 months ] [ Designated as safety issue: No ]
    The Harvard Trauma Questionnaire measures PTSD Symptoms. This scale has 16 items and is rated on a Likert scale from 1-4. The total score is sum of the scores divided by the number of items. Higher scores indicated higher levels of PTSD symptoms.


Enrollment: 82
Study Start Date: August 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mind-Body Skills Groups
12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
Behavioral: Mind-Body Skills Groups
12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
No Intervention: Delayed Intervention
Comparison group not receiving intervention until after the initial intervention was completed.

Detailed Description:

The objective of this study is to determine whether participation in a group program incorporating mind-body techniques decreases symptoms of posttraumatic stress in adolescents. Students will be screened for posttraumatic stress using the Harvard Trauma Questionnaire and eighty-two qualifying students will be randomly assigned to a 12-session mind-body group program or a wait-list delayed intervention group. The program will be conducted by the teachers at a high school in Kosovo and include meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques. Changes in posttraumatic stress symptoms will be measured using the Harvard Trauma Questionnaire.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Students having posttraumatic stress (PTSD) as defined according to a scoring algorithm of the Harvard Trauma Questionnaire previously described by the Harvard Refugee Trauma group and used in a Kosovar Albanian population. This definition of PTSD requires a score of 3 or 4, on a Likert scale of 1-4, on at least one of the four of the reexperiencing symptoms (Criterion B), at least 3 of the 7 avoidance and numbing symptoms (Criterion C), and at least 2 of the 5 arousal symptoms (Criterion D) in addition to exposure to a traumatic event (Criterion A).

Exclusion Criteria:

  • No specific exclusion criteria. Students having PTSD symptoms as defined above may participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136357

Locations
Former Yugoslavia
Jeta e Re High School
Suhareka, Kosovo, Former Yugoslavia
Sponsors and Collaborators
The Center for Mind-Body Medicine
Investigators
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James S. Gordon, M.D., Founder and Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT00136357     History of Changes
Other Study ID Numbers: MBSG 2004-01
Study First Received: August 26, 2005
Results First Received: January 27, 2014
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The Center for Mind-Body Medicine:
posttraumatic stress
mind-body techniques
war
adolescents

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2015