Portland VA Medical Center
Portland, Oregon, 97239, United States
NCT Number: NCT06973876
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 18
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.
Portland VA Medical Center
Fed
Acronym: STRETCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03824860
Chemotherapy-induced Peripheral Neuropathy, Chronic Pain
Boston, Massachusetts, United States
View Trial DetailsNCT07037992
Chronic Pain, Laparoscopic Donor Nephrectomy
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
View Trial DetailsNCT05299294
Chronic Pain, Nervous System Diseases
Angers, France
View Trial DetailsNCT05503173
Agnosia, Chronic Pain
Boston, Massachusetts, United States
View Trial Details