Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework

Contemp Clin Trials. 2024 Feb:137:107411. doi: 10.1016/j.cct.2023.107411. Epub 2023 Dec 14.

Abstract

Background: Chronic pain affects up to half of individuals taking opioid agonist therapy (OAT; i.e., methadone and buprenorphine) for opioid use disorder (OUD), and yoga-based interventions may be useful for decreasing pain-related disability. Whereas more yoga practice (i.e., higher "dosage") may improve pain-related outcomes, it can be challenging for people with chronic pain taking OAT to attend class regularly and sustain a regular personal yoga practice. Therefore, we plan to optimize a yoga-based intervention (YBI) package in order to support class attendance and personal practice, thus maximizing the yoga dose received.

Study design: Using the Multiphase Optimization Strategy (MOST) framework, we will conduct a factorial experiment to examine four intervention components that may be added to a weekly yoga class as part of a YBI. Components include: 1) personal practice videos featuring study yoga teachers, 2) two private sessions with a yoga teacher, 3) daily text messages to inspire personal practice, and 4) monetary incentives for class attendance. The primary outcome will be minutes per week engaged in yoga (including class attendance and personal practice). We plan to enroll 192 adults with chronic pain who are taking OAT for OUD in this 2x2x2x2 factorial experiment.

Conclusion: Results of the study will guide development of an optimized yoga-based intervention package that maximizes dosage of yoga received. The final treatment package can be tested in a multisite efficacy trial of yoga to reduce pain interference in daily functioning in people with chronic pain who are taking OAT.

Trial registration: Pre-registration of the study was completed on ClinicalTrials.gov (identifier: NCT04641221).

Keywords: Chronic pain; MOST; Opioid agonist therapy; Opioid use disorder; Yoga.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Analgesics, Opioid / therapeutic use
  • Buprenorphine* / therapeutic use
  • Chronic Pain* / drug therapy
  • Humans
  • Opioid-Related Disorders* / drug therapy
  • Pain Management
  • Yoga*

Substances

  • Analgesics, Opioid
  • Buprenorphine

Associated data

  • ClinicalTrials.gov/NCT04641221