Clinical trial NCT06497400: Brazilian Jiu Jitsu vs. Yoga for Treating Symptoms of PTSD
Official title: Pilot Randomized Controlled Trial of Brazilian Jiu Jitsu (BJJ) Training Versus Hatha Yoga for Symptoms of Post-Traumatic Stress Disorder (PTSD) Among U.S. Male Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 U.S. service members/veterans 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 (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.

Eligibility criteria: Inclusion Criteria:

* Male U.S. service member or veteran
* Current evidence of significant symptoms of PTSD, indicative of probable diagnosis of PTSD, as determined from the 20-item PCL-5, and positive screen on the PTSD subscale of the Psychiatric Diagnostic Screening Questionnaire (PDSQ)
* Denial of suicidal/homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis
* Ability to read and speak English
* between 18 - 44 years of age or older

Exclusion Criteria:

* Previous enrollment (past 6 months) in JJ regimen or Yoga regimen consistent with the regimens to be provided as the study interventions
* Major psychiatric disorder (e.g. bipolar disorder) uncontrolled and likely to interfere with treatment delivery (as determined by clinician assessment)
* Current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery (i.e. exhibiting significant withdrawal symptoms or inability to refrain from substance dependence immediately prior to intervention sessions).
* Brain injury prohibiting speech, writing, and purposeful actions or screen positive for traumatic brain injury (history of concussion is acceptable).
* Cognitive impairment that prohibits informed consent and/or compliance to the study protocol.
* Contraindication to significant physical activity with BJJ or Yoga.

Primary outcomes:
measure: Change in PTSD Checklist - 5 (PCL-5) score
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
Secondary outcomes:
measure: Change in Posttraumatic Growth Inventory-Short form (PTGI-SF)
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in Brief Symptom Inventory -18 (BSI-18) score
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in score on the Centers for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in score on the Pain Outcomes Questionnaire - Short Form (POQ)
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in Use of Medications
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
measure: Change in score on the Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Change from pre-intervention to 2 months after completion of BJJ training
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida/Center of Excellence for Aging and Brain Repair/department of Neurosurgery
state: Florida
Study officials:
References: