Feasibility of a Yoga Program for Veterans With PTSD

This study is designed to examine the feasibility of a 12-week yoga program on physiological and psychological health and its neurobiological mechanisms in N=15 veterans with posttraumatic stress disorder (PTSD). The investigators will be examining specific parameters of health and mechanisms before and after the yoga program.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: Yoga Intervention

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53207
      • Marquette University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• U.S. Military Veteran
• 18 years of age or older
• Diagnosis of PTSD as assessed by a score of >30 on the PTSD-Checklist Version 5 (PCL-5)
• Willing and able to attend testing and yoga sessions at the Athletic and Human Research Performance Center (AHPRC) on the campus of Marquette University
• Clear to participate in physical activity based on the Physical Activity Readiness Questionnaire (PARQ+)

Exclusion Criteria:

• Currently pregnant or trying to become pregnant
• Positive score to one or more items on the PAR-Q+ without physician approval
• Already established regular use of yoga (i.e., more than one day per week)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Yoga Intervention; The yoga exercise program will be conducted at the Marquette campus and will consist of one session per week for 12 weeks. The duration of each session will be approximately one hour. The program the investigators will use is the Mindful Resilience for Trauma Recovery Program (https://www.veteransyogaproject.org/), an evidence-informed practice adapted for veterans with PTSD based on clinical and neuroscientific knowledge. This program is a 12-week protocol developed by a licensed clinical psychologist and is publicly available. All yoga sessions will be standardized based on the resilience program guidelines.

Other: Yoga Intervention; The yoga exercise program will be conducted at the Marquette campus and will consist of one session per week for 12 weeks. The duration of each session will be approximately one hour. The program the investigators will use is the Mindful Resilience for Trauma Recovery Program (https://www.veteransyogaproject.org/), an evidence-informed practice adapted for veterans with PTSD based on clinical and neuroscientific knowledge. This program is a 12-week protocol developed by a licensed clinical psychologist and is publicly available. All yoga sessions will be standardized based on the resilience program guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocannabinoid assay	Endocannabinoid ligands reported in ng/ml	Change in ligands from baseline to12 weeks
Cortisol assay	Cortisol reported in μg/dL	Change in cortisol from baseline to12 weeks
Cognitive functioning using a computerized battery	Performance on cognitive tasks reported in accuracy and reaction time	Change in performance from baseline to12 weeks
Body Mass Index (BMI)	Body Mass Index (BMI) calculated by height and weight	Change in BMI from baseline to12 weeks
Blood pressure	Blood pressure reported in systolic and diastolic (mmHg)	Change in blood pressure from baseline to12 weeks
Heart rate	Heart rate reported in beats per minute (BPM)	Change in heart rate from baseline to12 weeks
Heart rate variability (HRV)	Heart rate variability (HRV) reported in the standard deviation of the RR intervals (distance between heartbeats) as quantified on standard electrocardiogram (ECG)	Change in HRV from baseline to12 weeks
Lung functioning	Lung functioning measured by spirometry reported in vital capacity (VC)	Change in lung functioning from baseline to12 weeks
Range of motion	Range of motion measured by goniometer reported in degrees	Change in range of motion from baseline to12 weeks
Body composition	Body composition measured by dual-energy x-ray absorptiometry (DEXA) reported in volume cubic meters (m3) and mass (kilograms)	Change in body composition from baseline to12 weeks
Hand grip strength	Hand grip strength measured by a dynamometer reported in pounds (lbs)	Change in hand grip strength from baseline to12 weeks
Aerobic fitness	Aerobic fitness measured by a submaximal graded exercise test reported in the volume of oxygen consumed (VO2)	Change in aerobic fitness from baseline to12 weeks
Physical activity	Physical activity measured by a accelerometer reported in change in velocity over time (meters per seconds)	Change in physical activity from baseline to12 weeks
Severity of posttraumatic stress disorder (PTSD)	Scores on the Clinician Administered PTSD Scale (CAPS-5) (range 0-80; higher scores indicate more severity)	Change in scores from baseline to12 weeks
Frequency of physical activity	Scores on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) reported in hours and minutes each day	Change in scores from baseline to12 weeks
Physical health rating	Scores on the Medical Outcomes Study-Short Form (SF-36) (range 0-100; higher scores indicate better health outcome)	Change in scores from baseline to12 weeks
Severity of sleep disturbance	Scores on the Pittsburgh Sleep Quality Index (PSQI) (range 0-21; higher scores indicate worse sleep quality)	Change in scores from baseline to12 weeks
Mindfulness rating	Scores on the Five Facet Mindfulness Questionnaire (FFMQ) (range 39-195; higher scores indicate more mindfulness)	Change in scores from baseline to12 weeks
Frequency of yoga rating	Scores on the Yoga and Self-efficacy Scale (YSES) (range 12-108; higher scores indicate more engagement with yoga practices)	Change in scores from baseline to12 weeks

Collaborators and Investigators

• Sponsor: Marquette University
• Investigators: Principal Investigator: Jacklynn Fitzgerald, PhD, Marquette University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 28, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HR- 3973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No