Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; Yoga

• Registration Number: NCT06973876
• Lead Sponsor: Portland VA Medical Center

Brief Summary

The goal of this clinical trial is to see if pre-recorded yoga videos are as helpful for chronic pain as online yoga sessions taught in real time. The main questions it aims to answer are:

Are pre-recorded yoga videos an acceptable and practical tool and could they be used more broadly?

Are pre-recorded yoga videos no worse than online yoga sessions taught in real time for managing chronic pain?

Researchers will compare changes in chronic pain, mental health, and quality of life outcomes for participants who attend pre-recorded yoga videos versus online yoga sessions taught in real time.

Over the course of 4 months, participants will:

Attend a 5-session virtual yoga course. Continue virtual yoga practice for 12-weeks on their own or in a VA online class. Complete 3 online assessments and a brief exit interview.

Detailed Description

The overarching goals of the proposed research are to pilot test feasibility and acceptability of a 5-session yoga primer to the mindful practice of pain-sensitive teleyoga and its impact on subsequent teleyoga practice delivered either synchronously or asynchronously. The research will also test the preliminary effectiveness of teleyoga practice on outcomes related to chronic pain, mental health, and quality of life.

* Aim 1: Assess acceptability and feasibility of trial methodology to inform future larger-scale trials.

* Aim 2: Use intent-to-treat analysis and random effect regression models to compare changes in pain interference, pain severity, physical function, quality of life, depression, and anxiety between participants who attend synchronous vs. asynchronous teleyoga.

The primary purpose of a pilot study is to assess feasibility of methods to inform future larger studies. However, inferential analyses may be appropriate to help ascertain estimates of variability for the primary and secondary outcomes that can be used to power larger trials. To that end, the investigators will use intent-to-treat procedures and random effect regression models to compare changes in the outcome variables between patients who receive asynchronous vs. synchronous teleyoga.

Hypothesis: The investigators predict that asynchronous teleyoga will be non-inferior to synchronous teleyoga in reducing the primary outcome of pain interference, as well as across secondary outcomes

Study Timeline

• Study Start: 2025-01-10
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• U.S. Veteran enrolled at VAPORHCS and has established care with a VA medical or mental health provider.
• Diagnosed with musculoskeletal pain, confirmed by electronic health record review and phone screening.
• Has an average pain severity of at least 4 in the past 3 months, assessed by items 1-5 of the Brief Pain Inventory, Short Form.
• Aged 18 or over.
• Capable of using video teleconferencing to complete enrollment, assessment, and video interventions.
• Meets physical readiness, assessed by the Physical Activity Readiness Questionnaire (PAR-Q) and approved for yoga participation by their primary care team or physical therapy team.
• Able to sit and stand from the floor without assistance
• Able to ambulate community distances without an assistive device
• Intact sensation in lower extremities below the knees

Exclusion Criteria

• Unable to read and write in English.
• Unable to freely give informed consent.
• Recent (past 3 months) psychotic symptoms consistent with a diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or other psychotic disorder and unrelated to PTSD. Assessed by medical record review and provider team.
• Practicing yoga regularly defined as weekly or biweekly practice of 60 or more minutes for 6 months or more.
• Recent (past 3 months) history of suicidal gesture related to physical pain or active suicidal ideation (plan, intent, means).
• Concurrently enrolled in another research protocol involving a pain focused intervention.
• Upcoming surgery that would impact yoga practice.
• Active alcohol/other substance abuse or dependence (unless actively engaged in treatment). Assessed via the The Tobacco, Alcohol, prescription medication and other Substance use Tool (TAPS). A cutoff of 2 will be used to rule out.
• Joint replacement within the past 12 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory Short Form (BPI-SF)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The Brief Pain Inventory Short Form (BPI-SF) is a widely used 9-item tool for assessing pain severity and pain interference. The primary outcome will be the Pain Interference Subscale of the BPI-SF. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Pain Severity Subscale (BPI-SF) is a widely used 9-item tool for assessing pain severity and pain interference. Scores are on a range of 0 - 10, with higher scores indicating more severe pain.
PROMIS Physical Function 4-Item Short Form Instrument	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Physical Functioning will be assessed with the 4-item PROMIS Physical Functioning scale. The physical function form asks the participant to rate a series of physical function related questions on 5-point Likert scale, with one representing a better outcome.
Veterans RAND 12-Item Health Survey (VR-12)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The Veterans RAND 12-Item Health Survey (VR-12) is a 12-item instrument used to measure health related quality of life in Veterans. VR-12 scores are summarized into two scores, a Physical Health component score and a Mental Health component score. Each component score is on a range of 0 - 100, with higher scores indicating more impairment in physical or mental health, respectively.
Patient Health Questionnaire-9 (PHQ-9)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale that can be used to screen, diagnose, monitor, and measure the severity of depression. The PHQ-9 scoring system ranges from 0 to 27, with higher scores indicating more severe depression
Generalized Anxiety Disorder 7-Item Scale	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Generalized Anxiety Disorder 7-Item Scale is designed for screening and measuring the severity of generalized anxiety symptoms. Scores on the GAD-7 range from 0 - 21, with higher scores indicating more severe symptoms of anxiety.
Five-facet Mindfulness Questionnaire	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The five-facet Mindfulness Questionnaire is a 15-item scale that measures the effectiveness of mindfulness strategies. Five subscales of mindfulness measure observing, describing, acting with awareness, non-judgment and non-reactivity. Average scores are calculated by summing the responses and dividing by the number of items, and indicate the average level of agreement with each subscale. The items use a 5-point Likert scale. Higher scores are indicative of someone who is more mindful in their everyday life.
Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2) is a 24-item scale measuring interoceptive sensibility, defined as the self-perceived tendency to focus on internal stimuli. Participants rate each item on a 6-point Likert scale, with higher scores indicating higher interoception. This measure has been shown to be reliable, including for those with a long-term health condition
PTSD Checklist for DMS-5 (PCL-5)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	The PTSD Checklist for DMS-5 (PCL-5) is a 20-item self-report questionnaire that assesses the severity of symptoms associated with exposure to trauma. Participants rate 20 items in the past month on a 5- point Likert scale. Total scores range from 0 (best outcome) to 80 (worst outcome).
Well-Being Signs	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Well-Being Signs is a three-question screening tool used to assess how Veterans are doing in their daily lives. Each question uses a 10-point Likert scale. An average score is calculated based on the ratings for each of the questions with higher scores indicating better well-being.
Pain Catastrophizing Scale	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Pain Catastrophizing Scale measures catastrophizing related to chronic pain and is used extensively in clinical practice and in research. The pain catastrophizing scale consists of 13 items These are divided into 3 domains: rumination, magnification and helplessness. The subject is asked to indicate how how well each sentence applies for them on a 4-point Likert scale. The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.
Teleyoga Attendance and Engagement (EHR & Digital Well-Being Data Collection)	Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18	Attendance and engagement during the Yoga Primer and each intervention arm will be collected. Virtual yoga completed as part of the 5-session primer and in the Synchronous Teleyoga arm will be documented via a note attached and have a visit assigned as well to chart on in the medical record. Attendance and engagement in the Asynchronous Teleyoga arm will be documented and tracked through Ompractice through participant internet protocol address, which participants consent to sharing when they sign up and read the terms of use.

Trial Locations

Locations (1)

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States