Clinical trial NCT06973876: Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain
Official title: Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Yoga
Keywords: chronic pain
yoga
synchronous telehealth
asynchronous telehealth
rural
Veterans
teleyoga
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: VHA Office of Rural Health
First posted: 2025-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research team will enroll 100 Veterans diagnosed with chronic pain to be randomized 1:1 using permuted block randomization with blocks of varying length to either synchronous teleyoga at VAPORHCS or asynchronous teleyoga via Ompractice. Virtual groups will be composed of 8-10 participants, which will require 5-7 cohorts of each group.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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.

Primary outcomes:
measure: Brief Pain Inventory Short Form (BPI-SF)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
Secondary outcomes:
measure: Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: PROMIS Physical Function 4-Item Short Form Instrument
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Veterans RAND 12-Item Health Survey (VR-12)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Generalized Anxiety Disorder 7-Item Scale
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Five-facet Mindfulness Questionnaire
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: PTSD Checklist for DMS-5 (PCL-5)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Well-Being Signs
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Pain Catastrophizing Scale
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
measure: Teleyoga Attendance and Engagement (EHR & Digital Well-Being Data Collection)
timeFrame: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
Other outcomes:
measure: Semi-structured interview
timeFrame: Week 18
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
References: