NCT06973876

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 7, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

chronic painyogasynchronous telehealthasynchronous telehealthruralVeteransteleyoga

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF

    Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18

  • PROMIS Physical Function 4-Item Short Form Instrument

    Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18

  • Veterans RAND 12-Item Health Survey (VR-12)

    Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18

  • Generalized Anxiety Disorder 7-Item Scale

    Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18

  • +6 more secondary outcomes

Other Outcomes (1)

  • Semi-structured interview

    Week 18

Study Arms (2)

Synchronous Teleyoga

PLACEBO COMPARATOR

Participants randomized to receive synchronous teleyoga 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 will be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes.

Behavioral: Pain-Sensitive Teleyoga PrimerBehavioral: Synchronous Teleyoga

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.

Behavioral: Pain-Sensitive Teleyoga PrimerBehavioral: Asynchronous Teleyoga

Interventions

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.

Asynchronous TeleyogaSynchronous Teleyoga

Participants randomized to receive synchronous teleyoga 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 will be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes.

Synchronous Teleyoga

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.

Asynchronous Teleyoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Noah Jacobson, MPH

CONTACT

Belle Zaccari, PsyD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

January 10, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations