NCT00136357

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

February 16, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

August 26, 2005

Results QC Date

January 27, 2014

Last Update Submit

February 2, 2015

Conditions

Stress Disorders, Post-traumatic

Keywords

posttraumatic stressmind-body techniqueswaradolescents

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mind-Body Skills Groups

EXPERIMENTAL

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

Delayed Intervention

NO INTERVENTION

Comparison group not receiving intervention until after the initial intervention was completed.

Interventions

Mind-Body Skills GroupsBEHAVIORAL

12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.

Mind-Body Skills Groups

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeta e Re High School

Suhareka, Kosovo, Federal Republic of Yugoslavia

Location

Related Publications (2)

  • 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. doi: 10.1023/B:JOTS.0000022620.13209.a0.

    PMID: 15141787BACKGROUND

  • Gordon JS, Staples JK, Blyta A, Bytyqi M, Wilson AT. Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial. J Clin Psychiatry. 2008 Sep;69(9):1469-76. doi: 10.4088/jcp.v69n0915. Epub 2008 Aug 1.

    PMID: 18945398DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Dr. James Gordon
Organization
The Center for Mind-Body Medicine
jgordon@cmbm.ort
202-966-7338

Study Officials

  • James S Gordon, MD

    The Center for Mind-Body Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founder and Director

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

August 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

February 16, 2015

Results First Posted

February 16, 2015

Record last verified: 2015-02

Locations

FE(1)