Stress Disorders, Post-traumaticNCT00136357
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups
A study testing Mind-Body Skills Groups in people with Stress Disorders, Post-traumatic, run by The Center for Mind-Body Medicine at 1 site in Federal Republic of Yugoslavia.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-traumatic
- What is being tested?
- Mind-Body Skills Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFederal Republic of Yugoslavia
- Study dates
- Aug 2004to May 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- No specific exclusion criteria. Students having PTSD symptoms as defined above may participate in the study.
Trial locations and contacts
1 site in 1 country.
Federal Republic of Yugoslavia1 site
Jeta e Re High School
Suhareka, Kosovo
About this study
Official title: Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stress Disorders, Post-traumatic
- Being tested
- Mind-Body Skills Groups
- Keywords
- posttraumatic stress, mind-body techniques, war, adolescents
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Skills GroupsBehavioural
12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mind-Body Skills Groups |
| Delayed Intervention | No intervention | Comparison group not receiving intervention until after the initial intervention was completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-traumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James S. Gordon, M.D., The Center for Mind-Body Medicine
- Investigators
- James S Gordon, MD, Principal investigator, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136357
- Sponsor's protocol ID
- MBSG 2004-01
- Status last verified
- Feb 2015
- First submitted
- 26 Aug 2005
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15141787Gordon 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.
PubMed 18945398
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00136357
- Acronym / sponsor ID
- MBSG 2004-01
- Conditions
- Stress Disorders, Post-traumatic
- Keywords
- posttraumatic stress, mind-body techniques, war, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Behavioral: Mind-Body Skills Groups12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques. |
| Delayed Intervention | No intervention | –Comparison group not receiving intervention until after the initial intervention was completed. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- No specific exclusion criteria. Students having PTSD symptoms as defined above may participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Skills Groups12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques. | Behavioural | Mind-Body Skills Groups |
Primary outcome
Harvard Trauma Questionnaire
Time frame: Baseline, 12 weeks, 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15141787Gordon 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.
- Derived from this study: PubMed 18945398Gordon 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.
- Center for Mind-Body Medicine websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James S Gordon, MD principal investigator
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Skills Groups in people with Stress Disorders, Post-traumatic, run by The Center for Mind-Body Medicine at 1 site in Federal Republic of Yugoslavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Federal Republic of Yugoslavia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Trauma Questionnaire (time frame: Baseline, 12 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.