NCT06497400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
5.2 years until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

7.1 years

First QC Date

April 19, 2019

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Checklist - 5 (PCL-5) score

    There are 20 questions that inquire about the different symptoms that correspond to 4 different types of PTSD symptoms (intrusion, avoidances, negative affect and hyperarousal). Each item is scored on a 5-point Likert scale from 0 (hasn't bothered a person in the past 2 weeks) to 4 (bothers the person all the time). We used total score on this test.

    Change from pre-intervention to 2 months after completion of BJJ training

Secondary Outcomes (7)

  • Change in Posttraumatic Growth Inventory-Short form (PTGI-SF)

    Change from pre-intervention to 2 months after completion of BJJ training

  • Change in Brief Symptom Inventory -18 (BSI-18) score

    Change from pre-intervention to 2 months after completion of BJJ training

  • Change in score on the Centers for Epidemiological Studies Depression Scale (CES-D)

    Change from pre-intervention to 2 months after completion of BJJ training

  • Change in score on the Pittsburgh Sleep Quality Index (PSQI)

    Change from pre-intervention to 2 months after completion of BJJ training

  • Change in score on the Pain Outcomes Questionnaire - Short Form (POQ)

    Change from pre-intervention to 2 months after completion of BJJ training

  • +2 more secondary outcomes

Study Arms (3)

Brazilian Jiu Jitsu

ACTIVE COMPARATOR

Jiu Jitsu intervention for ten weeks

Other: Brazilian Jiu Jitsu

Hatha Yoga

ACTIVE COMPARATOR

Yoga intervention for ten weeks

Other: Hatha Yoga

Waitlist

ACTIVE COMPARATOR

Waitlist group for 5 weeks, then allowed to chose if they want to be in Group A Jiu Jitsu or Group B Yoga for ten week intervention

Other: Waitlist

Interventions

Instruction of two classes each week for ten weeks of Brazilian Jiu Jitsu

Brazilian Jiu Jitsu

Instruction of two classes each week for ten weeks of Hatha Yoga

Hatha Yoga

Participant will waitlist for 5 weeks and then be allowed to decide which intervention they want to do Group A/ Jiu Jitsu or Group B/Yoga for ten weeks..

Waitlist

Eligibility Criteria

Age18 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida/Center of Excellence for Aging and Brain Repair/department of Neurosurgery

Tampa, Florida, 33613-4706, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2019

First Posted

July 11, 2024

Study Start

July 30, 2017

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations