Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study (PROGRESS)

Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study

Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study

The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).

The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best. Online evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.

A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).

Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.

A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.

A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.

Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention

Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

We will utilize EMR and database records to compare treatment groups for healthcare utilization (e.g., medical visits) during final 3 months of the study vs. 3 months prior to enrollment.

Inclusion Criteria: At least 18 years of age or older of either sex (and all genders). Chronic pain (pain that occurs on at least half of the days of 3 months or more). Past-month average pain intensity score of at least 3/10. Ability to adhere to and complete study protocols. Exclusion Criteria: Inability to provide informed consent. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment. Active suicidality at screening. Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort. Receipt of either study treatment in the past 3 months.