Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497400
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2019-04-19
Brief Title:
Pilot Randomized Controlled Trial of Brazilian Jiu Jitsu vs Yoga for Symptoms of PTSD
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Pilot Randomized Controlled Trial of Brazilian Jiu Jitsu BJJ Training Versus Hatha Yoga for Symptoms of Post-Traumatic Stress Disorder PTSD Among US Male Veterans
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JOYPTSDVET
Brief Summary:
Post-traumatic stress disorder PTSD is a disabling anxiety disorder that may occur after witnessing a traumatic event and that evokes a combination of intrusion and avoidance symptoms negative alterations in cognitions and mood and alterations in arousal and reactivity1
The primary objective of this pilot randomized controlled trial is to estimate and compare the effects of the practice of Brazilian Jiu Jitsu BJJ vs hatha yoga vs a waitlist control condition in influencing symptoms of PTSD related comorbidities post-traumatic growth and quality of life among US service membersveterans with current symptoms of PTSD In addition objective measurements comparisons of stress and sleep quality will be made through the collection and evaluation of salivary alpha amylase hair cortisol and actigraphy a non-invasive way to measure activity cycles
The primary objective of this pilot randomized controlled trial is to estimate and compare the effects of the practice of Brazilian Jiu Jitsu BJJ vs hatha yoga vs a waitlist control condition in influencing symptoms of PTSD related comorbidities post-traumatic growth and quality of life among US service membersveterans with current symptoms of PTSD In addition objective measurements comparisons of stress and sleep quality will be made through the collection and evaluation of salivary alpha amylase hair cortisol and actigraphy a non-invasive way to measure activity cycles
Detailed Description:
The design is a three arm randomized controlled pilot trial comparing the effects of a 10-week BJJ program n10 and a 10-week hatha yoga program n10 vs a 5-week waitlist control regimen n5 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 US 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 BJJYoga 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 andor Yoga in reducing symptoms of PTSD and related comorbidities
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 andor Yoga in reducing symptoms of PTSD and related comorbidities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None