Randomized Comparative Effectiveness Study of 1-Session vs. 8-Session Online Behavioral Treatment for Chronic Pain: Protocol for the national PROGRESS study.
Publication/Presentation Date
2-19-2026
Abstract
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 two evidence-based online (telehealth) behavioral group treatments for chronic pain (1-session ER vs. 8 session CBT) in a nationally representative sample derived from six study sites.
METHODS: 1,200 adults ≥18 years of age with any type of pain ≥3 months with past-month intensity ≥3/10 will be recruited from six 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 two 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 six 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.
ISSN
1526-4637
Published In/Presented At
Adair Monson, E., Mardian, A., Saxena, K., Dorsonne, B., Hailu, A. Y., Heggan, E., Riazi, G., Slater, K., Poupore-King, H., Clifton, J., Perez, L., Tian, L., Porter, J., Denton, S., Hanson, E. R., Miefert, J., Thorn, B. E., Mackey, S. C., Cheung, M., & Darnall, B. D. (2026). Randomized Comparative Effectiveness Study of 1-Session vs. 8-Session Online Behavioral Treatment for Chronic Pain: Protocol for the national PROGRESS study. Pain medicine (Malden, Mass.), pnag027. Advance online publication. https://doi.org/10.1093/pm/pnag027
Disciplines
Psychiatry
PubMedID
41712512
Department(s)
Department of Psychiatry
Document Type
Article