Randomized comparative effectiveness study of 1-session vs 8-session online behavioral treatment for chronic pain: protocol for the national PROGRESS study.

INTRODUCTION

Evidence-based behavioral pain treatments are often inaccessible or infeasible for patients. A 1-session pain relief skills class (Empowered Relief; ER) has shown efficacy for multidimensional symptom reduction in various homogenous pain populations. Comparative effectiveness evidence in heterogeneous chronic pain is needed to inform decision-making and patient matching to treatment.

OBJECTIVES

Conduct a non-inferiority comparative effectiveness trial of 2 evidence-based online (telehealth) behavioral group treatments for chronic pain (1-session ER vs 8-session CBT) in a nationally representative sample derived from 6 study sites.

METHODS

1200 adults ≥18 years of age with any type of pain ≥3 months with past-month intensity ≥3/10 will be recruited from 6 study sites. Participants are randomized 1:1 to either the online 1-session or the 8-session behavioral intervention. Patient-reported data are collected to 6 months post-treatment. Medical history, diagnoses, and healthcare utilization are obtained via medical records.

MAIN OUTCOME MEASURES: Multi-primary outcomes are changes in pain intensity and pain interference from baseline to 3 months post-treatment with hypothesized non-inferiority between the 2 study treatments. Statistical analyses include mixed models for repeated measures (MMRM). Priority secondary outcomes include sleep disturbance, pain catastrophizing, anxiety, and pain bothersomeness. Exploratory heterogeneity of treatment effects will be examined.

ETHICS AND DISSEMINATION: The study protocol was approved by all 6 site Institutional Review Boards including Stanford University School of Medicine (IRB 65439) as the coordinating site. Results will be published in peer-reviewed journals. PCORI (funder), participants, and advisors will receive summaries of the findings.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05612750.