PTSDNCT06123065
Feasibility and Efficacy of A Yoga Intervention for Comorbid Chronic Pain and PTSD
A study testing Yoga in people with PTSD and Chronic Pain, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
The goal of this pilot quasi-randomized study is test the feasibility, acceptability, and initial efficacy of Yoga for Warriors treatment program for comorbid chronic pain and PTSD, conducted virtually through the Richmond Veterans Affairs Medical Center (RICVAMC). the main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Chronic Pain
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Aug 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
- Diagnosis of chronic pain (defined as pain for > 3 months) in the electronic medical record and a score of 50 or more on the Pain Disability Questionnaire (PDQ)
- Probable PTSD defined as being above the clinical threshold on the PTSD Checklist for DSM-5 (PCL-5), sum score at or above 25
- Able to stand up from sitting on the floor without assistance
- Able to ambulate community distances without an assistive device
- Intact sensation in lower extremities below knees
- Medical clearance by primary care provider
- Access to a computer/laptop/ipad with internet and video capability.
Who cannot join
- Fall risk
- Pregnancy
- Joint replacement within the past 12 months
- Active alcohol/other substance abuse or dependence (unless actively engaged in treatment)
- Current psychotic disorder or hospitalization with psychotic symptoms in past 3 months
- Active (past 3 months) suicidal or homicidal ideation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond Veterans Affairs Medical Center
Richmond, Virginia, 23249
About this study
Official title: Yoga for Warriors: A Pilot Study of Feasibility and Efficacy of A Yoga Intervention for Veterans With Comorbid Chronic Pain and PTSD
The goal of this pilot quasi-randomized study is test the feasibility, acceptability, and initial efficacy of Yoga for Warriors treatment program for comorbid chronic pain and PTSD, conducted virtually through the Richmond Veterans Affairs Medical Center (RICVAMC).
the main questions it aims to answer are:
- Whether a virtual intervention for chronic pain and PTSD is feasible and acceptable for veterans.
- Using a wait-list control group design, to determine preliminary efficacy of the intervention.
- Examine follow-up data to determine if benefits are maintained over time.
Read the detailed description
The study will be a pilot quasi-randomized controlled design comparing the 8-session Yoga for Warriors program, conducted via a web-based platform, utilizing a wait-list control, with wait-list participants being enrolled in subsequent groups. Measures of treatment satisfaction will be given and rates of initiation following screening and drop-out will be measured. A battery of assessments will be given at baseline (group introduction), at mid-point (around session 4), and following completion of the group. To determine maintenance effects, select assessments and re-administration of the study assessment battery will be conducted 3 months post-completion.
Potentially interested participants will be screened for eligibility. Screening for eligibility will occur over the phone and those who are interested in participating and willing to engage in the online format and who meet inclusion criteria based on study staff screening will go through the informed consent process over the phone or virtually. Collection of informed consent from participants will not include written documentation of informed consent given the fully virtual nature of this study during the coronavirus pandemic (COVID-19) restrictions (waiver of documentation of consent has been submitted). Paperless recording of willingness to participate will take place, with no written documentation of consent to participate. Participants will attend an initial online orientation session (prior to the first yoga session), either in a group format or individually, where they will be provided information on the group, will be randomized into the treatment group or to the wait-list control group. To attend the orientation session and all yoga sessions, participants will be emailed the specific, secured link to the online platform. Participants will complete the measures over the phone with the study coordinator. This will be an 8 week (+1 orientation session) group conducted remotely, online, with additional self-report measures completed mid-treatment, post-treatment, and at follow-up, in the same manner as described above.
- Conditions
- PTSD, Chronic Pain
- Being tested
- Yoga
- Keywords
- Yoga, Virtual Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Complementary and Alternative Intervention
8 week Yoga for chronic pain and PTSD group intervention, conducted virtually
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Immediately enrolled into Yoga intervention. Completed orientation and baseline measures then began 8-week yoga group intervention. Receives: Behavioral: Yoga |
| Waitlist | Other | Delayed Intervention. Waitlist individuals attended orientation and completed baseline measures. After completion of re-assessment of measures 8 weeks later, then enrolled into Active arm. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for Diagnostic and Statistic Manual for Mental Disorders 5 (DSM-5)
Assess current symptoms of PTSD in line with DSM-5 criteria (20 items)
Measured: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up
Pain Disability Questionnaire
Assesses self report of impact of pain in functioning (15 items)
Measured: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated on 1 to 10-point scale; higher scores indicate worse outcome
Pain Catastrophizing Scale
Assesses self report of thoughts and worries related to chronic pain (13 items)
Measured: current; past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated 0 to 4; higher scores indicate worse outcomes
Secondary outcomes (7)
Client Satisfaction Questionnaire-8 (CSQ-8)
Th CSQ is an 8-item measure assesses general intervention satisfaction
Measured: Time in intervention; Assessed at post-treatment (8 weeks); Items rated 1 to 4; higher scores indicate better outcomes
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 assesses depression severity
Measured: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7 measures anxiety experienced
Measured: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Patient Reported Outcome Measurement Information System (PROMIS) Short Form Anger
Assesses emotional distress and anger (5 items)
Measured: Past 7 days; assessed at baseline and post-treatment (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean worse outcomes
Patient Reported Outcome Measurement Information System (PROMIS) Short Form Social Roles
Assesses ability to participate in social roles and activities
Measured: Past 7 days; assessed at baseline and post-treatment; (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean better outcomes
Tampa Scale for Kinesiophobia (TSK-11)
The TSK-11 is an 11-item scale used to measure general perceptions of pain interference
Measured: Current; assessed at baseline, mid-treatment (4 weeks), post-treatment (8 weeks), 3 month follow up; Items rated 1 to 4; higher scores indicate worse outcomes
Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (LES-Q-SF)
The Q-LES-Q-SF is a 16-item scale used to measure quality of life
Measured: past week; assessed at baseline, post-treatment (8 weeks), 3 month follow up; Items rated 1 to 5; higher scores indicate better outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Apr 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Delayed cross-over design, with a Waitlist control. This study was a quasi-randomization to Active or Waitlist and Waitlist individuals were then moved to the Active group after assessment.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University, McGuire Research Institute
- Responsible party
- Principal investigator, Suzzette M. Chopin, PhD, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- Suzzette Chopin, Ph.D., Principal investigator, Richmond Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123065
- Sponsor's protocol ID
- 1572859
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully de-identified participant level data and aggregate data (all collected IPD) will be made available to qualified researchers who contact the Study PI per the Institutional Review Board's approved data management and sharing plan.
Publications
Chopin SM, Sheerin CM, Meyer BL. Yoga for warriors: An intervention for veterans with comorbid chronic pain and PTSD. Psychol Trauma. 2020 Nov;12(8):888-896. doi: 10.1037/tra0000649. Epub 2020 Jul 23.
PubMed 32700935Chopin SM, Zaur AJ, Fountain C, Claros Nunez A, Sheerin CM. Feasibility of a Virtual Adaptation of a Yoga Intervention for Veterans with Chronic Pain and Posttraumatic Stress Disorder. J Integr Complement Med. 2025 Jan;31(1):92-99. doi: 10.1089/jicm.2024.0512. Epub 2024 Sep 10.
PubMed 39253832
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Warriors: A Pilot Study of Feasibility and Efficacy of A Yoga Intervention for Veterans With Comorbid Chronic Pain and PTSD
- ClinicalTrials.gov ID
- NCT06123065
- Acronym / sponsor ID
- 1572859
- Conditions
- PTSD, Chronic Pain
- Keywords
- Yoga, Virtual Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Virginia Commonwealth University, McGuire Research Institute
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 8 Nov 2023 (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.
The goal of this pilot quasi-randomized study is test the feasibility, acceptability, and initial efficacy of Yoga for Warriors treatment program for comorbid chronic pain and PTSD, conducted virtually through the Richmond Veterans Affairs Medical Center (RICVAMC).
the main questions it aims to answer are:
- Whether a virtual intervention for chronic pain and PTSD is feasible and acceptable for veterans.
- Using a wait-list control group design, to determine preliminary efficacy of the intervention.
- Examine follow-up data to determine if benefits are maintained over time.
Detailed description
The study will be a pilot quasi-randomized controlled design comparing the 8-session Yoga for Warriors program, conducted via a web-based platform, utilizing a wait-list control, with wait-list participants being enrolled in subsequent groups. Measures of treatment satisfaction will be given and rates of initiation following screening and drop-out will be measured. A battery of assessments will be given at baseline (group introduction), at mid-point (around session 4), and following completion of the group. To determine maintenance effects, select assessments and re-administration of the study assessment battery will be conducted 3 months post-completion.
Potentially interested participants will be screened for eligibility. Screening for eligibility will occur over the phone and those who are interested in participating and willing to engage in the online format and who meet inclusion criteria based on study staff screening will go through the informed consent process over the phone or virtually. Collection of informed consent from participants will not include written documentation of informed consent given the fully virtual nature of this study during the coronavirus pandemic (COVID-19) restrictions (waiver of documentation of consent has been submitted). Paperless recording of willingness to participate will take place, with no written documentation of consent to participate. Participants will attend an initial online orientation session (prior to the first yoga session), either in a group format or individually, where they will be provided information on the group, will be randomized into the treatment group or to the wait-list control group. To attend the orientation session and all yoga sessions, participants will be emailed the specific, secured link to the online platform. Participants will complete the measures over the phone with the study coordinator. This will be an 8 week (+1 orientation session) group conducted remotely, online, with additional self-report measures completed mid-treatment, post-treatment, and at follow-up, in the same manner as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Delayed cross-over design, with a Waitlist control. This study was a quasi-randomization to Active or Waitlist and Waitlist individuals were then moved to the Active group after assessment.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: YogaImmediately enrolled into Yoga intervention. Completed orientation and baseline measures then began 8-week yoga group intervention. |
| Waitlist | Other | Behavioral: YogaDelayed Intervention. Waitlist individuals attended orientation and completed baseline measures. After completion of re-assessment of measures 8 weeks later, then enrolled into Active arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of chronic pain (defined as pain for > 3 months) in the electronic medical record and a score of 50 or more on the Pain Disability Questionnaire (PDQ)
- Probable PTSD defined as being above the clinical threshold on the PTSD Checklist for DSM-5 (PCL-5), sum score at or above 25
- Able to stand up from sitting on the floor without assistance
- Able to ambulate community distances without an assistive device
- Intact sensation in lower extremities below knees
Key exclusion criteria (6 listed)
- Fall risk
- Pregnancy
- Joint replacement within the past 12 months
- Active alcohol/other substance abuse or dependence (unless actively engaged in treatment)
- Current psychotic disorder or hospitalization with psychotic symptoms in past 3 months
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 |
|---|---|---|
| YogaAlso: Complementary and Alternative Intervention8 week Yoga for chronic pain and PTSD group intervention, conducted virtually | Behavioural | Active, Waitlist |
Primary outcome
PTSD Checklist for Diagnostic and Statistic Manual for Mental Disorders 5 (DSM-5)
Time frame: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up
Assess current symptoms of PTSD in line with DSM-5 criteria (20 items)
Pain Disability Questionnaire
Time frame: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated on 1 to 10-point scale; higher scores indicate worse outcome
Assesses self report of impact of pain in functioning (15 items)
Pain Catastrophizing Scale
Time frame: current; past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated 0 to 4; higher scores indicate worse outcomes
Assesses self report of thoughts and worries related to chronic pain (13 items)
7 secondary outcomes
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Time in intervention; Assessed at post-treatment (8 weeks); Items rated 1 to 4; higher scores indicate better outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Patient Reported Outcome Measurement Information System (PROMIS) Short Form Anger
Time frame: Past 7 days; assessed at baseline and post-treatment (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean worse outcomes
Patient Reported Outcome Measurement Information System (PROMIS) Short Form Social Roles
Time frame: Past 7 days; assessed at baseline and post-treatment; (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean better outcomes
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Current; assessed at baseline, mid-treatment (4 weeks), post-treatment (8 weeks), 3 month follow up; Items rated 1 to 4; higher scores indicate worse outcomes
Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (LES-Q-SF)
Time frame: past week; assessed at baseline, post-treatment (8 weeks), 3 month follow up; Items rated 1 to 5; higher scores indicate better outcomes
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 8 Nov 2023.
- Background: PubMed 32700935Chopin SM, Sheerin CM, Meyer BL. Yoga for warriors: An intervention for veterans with comorbid chronic pain and PTSD. Psychol Trauma. 2020 Nov;12(8):888-896. doi: 10.1037/tra0000649. Epub 2020 Jul 23.
- Derived from this study: PubMed 39253832Chopin SM, Zaur AJ, Fountain C, Claros Nunez A, Sheerin CM. Feasibility of a Virtual Adaptation of a Yoga Intervention for Veterans with Chronic Pain and Posttraumatic Stress Disorder. J Integr Complement Med. 2025 Jan;31(1):92-99. doi: 10.1089/jicm.2024.0512. Epub 2024 Sep 10.
- Individual participant dataSharing planned: Yes. Fully de-identified participant level data and aggregate data (all collected IPD) will be made available to qualified researchers who contact the Study PI per the Institutional Review Board's approved data management and sharing plan.
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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.
Suzzette Chopin, Ph.D. principal investigator
Richmond Veteran Affairs Medical Center
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 in people with PTSD and Chronic Pain, run by Hunter Holmes Mcguire Veteran Affairs Medical Center 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 7 inclusion and 6 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 8 Nov 2023. 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?
PTSD Checklist for Diagnostic and Statistic Manual for Mental Disorders 5 (DSM-5) (time frame: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123065, which also lists 2 linked publications.
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 8 Nov 2023.