Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain
- Conditions
- Chronic PainYoga
- 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 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, we 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: We 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 to 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.
- Secondary Outcome Measures
Name Time Method Five-facet Mindfulness Questionnaire Baseline to Week 18 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.
Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2 Baseline to 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.
PTSD Checklist for DMS-5 (PCL-5) Baseline to 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. It corresponds to the DSM-5 symptom criteria for PTSD.
Well-Being Signs Baseline to Week 18 Well-Being Signs is a three-question screening tool used to assess how Veterans are doing in their daily lives.
Pain Catastrophizing Scale Baseline to Week 18 Pain Catastrophizing Scale measures catastrophizing related to chronic pain and is used extensively in clinical practice and in research.
Patient Health Questionnaire-9 (PHQ-9) Baseline to 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.
Generalized Anxiety Disorder 7-Item Scale Baseline to Week 18 Generalized Anxiety Disorder 7-Item Scale is designed for screening and measuring the severity of generalized anxiety symptoms.
Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF Baseline to Week 18 Pain Severity Subscale (BPI-SF) is a widely used 9-item tool for assessing pain severity and pain interference.
PROMIS Physical Function 4-Item Short Form Instrument Baseline to Week 18 PROMIS measures the physical functioning of patients with musculoskeletal disorders by assessing activities of daily living.
Veterans RAND 12-Item Health Survey (VR-12) Baseline to 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.
Trial Locations
- Locations (1)
Portland VA Medical Center
🇺🇸Portland, Oregon, United States