Stress Disorders, Post-TraumaticNCT05177757
Feasibility of a Yoga Program for Veterans With PTSD
A study testing Yoga Intervention in people with Stress Disorders, Post-Traumatic, run by Marquette University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Yoga Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 28 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Yoga Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | 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. Receives: Other: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocannabinoid assay
Endocannabinoid ligands reported in ng/ml
Measured: Change in ligands from baseline to12 weeks
Cortisol assay
Cortisol reported in μg/dL
Measured: Change in cortisol from baseline to12 weeks
Cognitive functioning using a computerized battery
Performance on cognitive tasks reported in accuracy and reaction time
Measured: Change in performance from baseline to12 weeks
Body Mass Index (BMI)
Body Mass Index (BMI) calculated by height and weight
Measured: Change in BMI from baseline to12 weeks
Blood pressure
Blood pressure reported in systolic and diastolic (mmHg)
Measured: Change in blood pressure from baseline to12 weeks
Heart rate
Heart rate reported in beats per minute (BPM)
Measured: 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)
Measured: Change in HRV from baseline to12 weeks
Lung functioning
Lung functioning measured by spirometry reported in vital capacity (VC)
Measured: Change in lung functioning from baseline to12 weeks
Range of motion
Range of motion measured by goniometer reported in degrees
Measured: 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)
Measured: Change in body composition from baseline to12 weeks
Hand grip strength
Hand grip strength measured by a dynamometer reported in pounds (lbs)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change in scores from baseline to12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start3 Jan 2022
- Primary completion27 May 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacklynn Fitzgerald, Marquette University
- Investigators
- Jacklynn Fitzgerald, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177757
- Sponsor's protocol ID
- HR- 3973
- Status last verified
- Sep 2022
- First submitted
- 10 Nov 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Yoga Program for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT05177757
- Acronym / sponsor ID
- HR- 3973
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Other: Yoga InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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+)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga InterventionThe 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 |
Primary outcome
Endocannabinoid assay
Time frame: Change in ligands from baseline to12 weeks
Endocannabinoid ligands reported in ng/ml
Cortisol assay
Time frame: Change in cortisol from baseline to12 weeks
Cortisol reported in μg/dL
Cognitive functioning using a computerized battery
Time frame: Change in performance from baseline to12 weeks
Performance on cognitive tasks reported in accuracy and reaction time
Body Mass Index (BMI)
Time frame: Change in BMI from baseline to12 weeks
Body Mass Index (BMI) calculated by height and weight
Blood pressure
Time frame: Change in blood pressure from baseline to12 weeks
Blood pressure reported in systolic and diastolic (mmHg)
Heart rate
Time frame: Change in heart rate from baseline to12 weeks
Heart rate reported in beats per minute (BPM)
Heart rate variability (HRV)
Time frame: Change in HRV from baseline to12 weeks
Heart rate variability (HRV) reported in the standard deviation of the RR intervals (distance between heartbeats) as quantified on standard electrocardiogram (ECG)
Lung functioning
Time frame: Change in lung functioning from baseline to12 weeks
Lung functioning measured by spirometry reported in vital capacity (VC)
Range of motion
Time frame: Change in range of motion from baseline to12 weeks
Range of motion measured by goniometer reported in degrees
Body composition
Time frame: Change in body composition from baseline to12 weeks
Body composition measured by dual-energy x-ray absorptiometry (DEXA) reported in volume cubic meters (m3) and mass (kilograms)
Hand grip strength
Time frame: Change in hand grip strength from baseline to12 weeks
Hand grip strength measured by a dynamometer reported in pounds (lbs)
Aerobic fitness
Time frame: Change in aerobic fitness from baseline to12 weeks
Aerobic fitness measured by a submaximal graded exercise test reported in the volume of oxygen consumed (VO2)
Physical activity
Time frame: Change in physical activity from baseline to12 weeks
Physical activity measured by a accelerometer reported in change in velocity over time (meters per seconds)
Severity of posttraumatic stress disorder (PTSD)
Time frame: Change in scores from baseline to12 weeks
Scores on the Clinician Administered PTSD Scale (CAPS-5) (range 0-80; higher scores indicate more severity)
Frequency of physical activity
Time frame: Change in scores from baseline to12 weeks
Scores on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) reported in hours and minutes each day
Physical health rating
Time frame: Change in scores from baseline to12 weeks
Scores on the Medical Outcomes Study-Short Form (SF-36) (range 0-100; higher scores indicate better health outcome)
Severity of sleep disturbance
Time frame: Change in scores from baseline to12 weeks
Scores on the Pittsburgh Sleep Quality Index (PSQI) (range 0-21; higher scores indicate worse sleep quality)
Mindfulness rating
Time frame: Change in scores from baseline to12 weeks
Scores on the Five Facet Mindfulness Questionnaire (FFMQ) (range 39-195; higher scores indicate more mindfulness)
Frequency of yoga rating
Time frame: Change in scores from baseline to12 weeks
Scores on the Yoga and Self-efficacy Scale (YSES) (range 12-108; higher scores indicate more engagement with yoga practices)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacklynn Fitzgerald, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Stress Disorders, Post-Traumatic, run by Marquette University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocannabinoid assay (time frame: Change in ligands from baseline to12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.