Feasibility and Efficacy of A Yoga Intervention for Comorbid Chronic Pain and PTSD

NCT ID: NCT06123065

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-08-30

Brief 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. Whether a virtual intervention for chronic pain and PTSD is feasible and acceptable for veterans.

2. Using a wait-list control group design, to determine preliminary efficacy of the intervention.

3. 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.

Conditions

PTSD; Chronic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

Immediately enrolled into Yoga intervention. Completed orientation and baseline measures then began 8-week yoga group intervention.

Group Type: EXPERIMENTAL

Yoga

Intervention Type: BEHAVIORAL

8 week Yoga for chronic pain and PTSD group intervention, conducted virtually

Waitlist

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.

Group Type: OTHER

Yoga

Intervention Type: BEHAVIORAL

8 week Yoga for chronic pain and PTSD group intervention, conducted virtually

Interventions

Yoga

8 week Yoga for chronic pain and PTSD group intervention, conducted virtually

Intervention Type: BEHAVIORAL

Other Intervention Names

Complementary and Alternative Intervention

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

McGuire Research Institute

OTHER

Sponsor Role: collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Suzzette M. Chopin, PhD

Study PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzzette Chopin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Richmond Veteran Affairs Medical Center

Locations

Richmond Veterans Affairs Medical Center

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32700935 (View on PubMed)

Chopin 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.

Reference Type: DERIVED

PMID: 39253832 (View on PubMed)

Other Identifiers

1572859

Identifier Type: -

Identifier Source: org_study_id