Finding studies
Finding studies
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Lead
University of South Florida
The design is a three arm randomized controlled pilot trial comparing the effects of a 10-week BJJ program (n=10) and a 10-week hatha yoga program (n=10) vs. a 5-week waitlist control regimen (n=5). Subjects randomly assigned to the waitlist condition will be offered the choice of participating in the BJJ or yoga intervention after the 5-week waitlist period. By trial inclusion criteria, all subjects will be male U.S. service members or veterans who report significant symptoms of PTSD (as determined by the 20-item PTSD checklist (PCL-5) and supplemental measures. Assessments will occur pre-intervention, at the midpoint of the intervention (5 weeks), at the end of the assigned intervention period (10 weeks), and at 2-month follow-up for the BJJ and yoga arms of the trial. Study variables will consist of reliable and valid self-report measures of symptom status to be completed by all study participants. In addition, saliva samples will be collected before and after individual sessions of BJJ/Yoga at 3 timepoints: first session, mid-point session at 5 weeks, and final session at 10 weeks. The same measurement schedule will be used for collection of hair cortisol samples and actigraphy assessment of sleep quality captured from wearing a watch for a one-week period of time at baseline, 5-weeks, and 10-weeks. The waitlist control group will wear the actigraphy watch at baseline and 5 weeks. The trial will estimate effect size of the 2 active treatment arms (BJJ, Yoga) compared to the waitlist condition, and similarly, examine whether the BJJ arm appears to be non-inferior to the Yoga arm of the trial. Whereas the trial, designed as a pilot, is not powered for formal hypothesis testing, estimates of effect size will be examined with respect to the following underlying hypotheses: 1. Both the BJJ and Hatha Yoga regimens will provide evidence suggestive of superiority compared to the waitlist control regimen with respect to the primary outcome of symptoms of PTSD, as well as secondary outcomes. 2. Results will provide evidence suggestive of non-inferiority of the BJJ regimen compared to Hatha Yoga with respect to the primary outcome of symptoms of PTSD, as well as secondary outcomes. Analyses will inform the design of a future planned large clinical trial to determine the potential benefit of BJJ and/or Yoga in reducing symptoms of PTSD and related comorbidities.
Age
18–44
Sex
MALE
Healthy volunteers
Accepted
