JMIR Publications

ABSTRACT

Background:

Chronic pain affects tens of millions of U.S. adults and continues to rise in prevalence. Non-pharmacologic behavioral pain treatments are greatly needed yet are often inaccessible, particularly in settings where medication prescribing is prioritized. This study aims to test the feasibility of a virtually delivered one-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain, or for comorbid opioid use disorder (OUD).

Methods:

This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants’ willingness to join the study no medical records or drug monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post-treatment, 2-weeks, and months 1-3) via online, paper, or phone formats to include individuals with limited online access and/or low literacy skills. At baseline participants complete demographic questions and 13 study measures [Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale (PCS), PROMIS Measures, and Opioid Craving Scale (OCS)]. Immediately post-treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness/utility, participant satisfaction, and likelihood of using the skills). At each remaining timepoint, participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes/no) and history of OUD (yes/no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8/10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1-month post-treatment. Discussion: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief® in this population and will inform the design of a future randomized, controlled trial testing online-delivered Empowered Relief® in chronic pain and comorbid OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT05057988