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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00136357
Other study ID # MBSG 2004-01
Secondary ID
Status Completed
Phase N/A
First received August 26, 2005
Last updated February 2, 2015
Start date August 2004
Est. completion date May 2005

Study information

Verified date February 2015
Source The Center for Mind-Body Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 19 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

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.

Locations

Country Name City State
Former Yugoslavia Jeta e Re High School Suhareka Kosovo

Sponsors (1)

Lead Sponsor Collaborator
The Center for Mind-Body Medicine

Country where clinical trial is conducted

Former Yugoslavia, 

References & Publications (1)

Gordon JS, Staples JK, Blyta A, Bytyqi M. Treatment of posttraumatic stress disorder in postwar Kosovo high school students using mind-body skills groups: a pilot study. J Trauma Stress. 2004 Apr;17(2):143-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Harvard Trauma Questionnaire 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. Baseline, 12 weeks, 3 months No
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