Trial Outcomes & Findings for Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups (NCT NCT00136357)
NCT ID: NCT00136357
Last Updated: 2015-02-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Baseline, 12 weeks, 3 months
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
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.
|
Delayed Intervention
Comparison group not receiving intervention until after the initial intervention was completed.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Delayed Intervention
Comparison group not receiving intervention until after the initial intervention was completed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups
Baseline characteristics by cohort
| Measure |
Mind-Body Skills Groups
n=41 Participants
12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
|
Delayed Intervention
n=41 Participants
Comparison group not receiving intervention until after the initial intervention was completed.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
16.3 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
16.3 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Kosovo
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 3 monthsThe 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.
Outcome measures
| Measure |
Mind-Body Skills Groups
n=38 Participants
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: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
|
Delayed Intervention
n=39 Participants
Comparison group not receiving intervention until after the initial intervention was completed.
|
|---|---|---|
|
Harvard Trauma Questionnaire
Baseline
|
2.5 units on a scale
Standard Deviation 0.3
|
2.5 units on a scale
Standard Deviation 0.3
|
|
Harvard Trauma Questionnaire
12 Week Assessment
|
2.0 units on a scale
Standard Deviation 0.3
|
2.4 units on a scale
Standard Deviation 0.4
|
|
Harvard Trauma Questionnaire
3 Month Assessment
|
2.0 units on a scale
Standard Deviation 0.3
|
2.1 units on a scale
Standard Deviation 0.3
|
Adverse Events
Mind-Body Skills Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place