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| Name | Class |
|---|---|
| VHA Office of Rural Health | UNKNOWN |
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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.
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synchronous Teleyoga | Placebo Comparator | Participants randomized to receive synchronous tele-yoga will be provided information so that they can attend VA Portland Health Care System (VAPORHCS) virtual yoga offerings. They will be encouraged to attend one class per week during the 12 weeks between randomization and follow-up assessment. Attendance may be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes. |
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| Asynchronous Teleyoga | Active Comparator | Participants randomized to receive asynchronous teleyoga will be provided information so that they can access to the digital library of yoga videos on Ompractice, an existing partner with VA Medical Centers. Ompractice contains a suite of yoga video content, and participants will be encouraged to complete one class per week during the 12 weeks between randomization and follow-up assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain-Sensitive Teleyoga Primer | Behavioral | The 5-session Pain-Sensitive Teleyoga Primer will be delivered synchronously to participants who will practice from their home. The purpose of the 5-session primer is two-fold: (1) it allows trained yoga instructors to determine physical abilities and limitations of patient participants so that pose modifications may be taught and (2) it provides education to participants on pain neuroscience, breathwork, relaxation, mindfulness, and interoception so that they may apply this knowledge to maximize the benefits of whichever yoga condition they are randomized to. Each session will last approximately 75 minutes. Participants will be provided with a supplementary handout to reinforce content from the sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory Short Form (BPI-SF) | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Semi-structured interview | Semi-structured interviews will be conducted following the final online data collection. Interviews will be used to collect additional feedback about the intervention and data collection experience. Rapid Qualitative Analysis will be used to analyze semi-structured interview data. | Week 18 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Synchronous Teleyoga | Behavioral | Participants randomized to receive synchronous tele-yoga will be provided information so that they can attend VAPORHCS virtual yoga offerings. They will be encouraged to attend one class per week during the 12 weeks between randomization and follow-up assessment. Attendance may be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes. |
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| Asynchronous Teleyoga | Behavioral | Participants randomized to receive asynchronous teleyoga will be provided information so that they can access to the digital library of yoga videos on Ompractice, an existing partner with VA Medical Centers. Ompractice contains a suite of yoga video content, and participants will be encouraged to complete one class per week during the 12 weeks between randomization and follow-up assessment. Attendance will be tracked by Ompractice and shared with VAPORHCS. |
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| PROMIS Physical Function 4-Item Short Form Instrument |
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. |
| Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Veterans RAND 12-Item Health Survey (VR-12) | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Patient Health Questionnaire-9 (PHQ-9) | 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 | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Generalized Anxiety Disorder 7-Item Scale | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Five-facet Mindfulness Questionnaire | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2) | 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 | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| PTSD Checklist for DMS-5 (PCL-5) | 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). | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Well-Being Signs | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Pain Catastrophizing Scale | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |
| Teleyoga Attendance and Engagement (EHR & Digital Well-Being Data Collection) | 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. | Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18 |