|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00136357 |
|
Date of registration:
|
26/08/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups
|
|
Scientific title:
|
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial |
|
Date of first enrolment:
|
August 2004 |
|
Target sample size:
|
82 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00136357 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
|
|
|
Countries of recruitment
|
|
Former Yugoslavia
| | | | | | | |
|
Contacts
|
|
Name:
|
James S Gordon, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Center for Mind-Body Medicine |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
14 Years
Age maximum:
19 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Stress Disorders, Post-Traumatic
|
|
Intervention(s)
|
|
Behavioral: Mind-Body Skills Groups
|
|
Primary Outcome(s)
|
|
Changes in score on the Harvard Trauma Questionnaire
|
|
Measurements taken at beginning of study, at 12 weeks (following intervention) and at 3 month follow-up
|
|
Secondary ID(s)
|
|
MBSG 2004-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|