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NCT05612750NARecruiting

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

Stanford University

Start Date

1/1/2023

Completion Date

5/1/2029

Summary

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).

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. At least 18 years of age or older of either sex (and all genders). 2. Chronic pain (pain that occurs on at least half of the days of 3 months or more). 3. Past-month average pain intensity score of at least 3/10. 4. Ability to adhere to and complete study protocols. Exclusion Criteria: 1. Inability to provide informed consent. 2. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment. 3. Active suicidality documented in medical records. 4. Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort. 5. Receipt of either study treatment in the past 3 months.

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

BEHAVIORAL

Empowered Relief

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Conditions

Pain, ChronicLupusPelvic Pain

Locations

Phoenix VA Health Care System

Phoenix, Arizona 85012

United States

SCAN Health Plan

Long Beach, California 90806

United States

Humana

Louisville, Kentucky 40202

United States

Lehigh Valley Health Network

Allentown, Pennsylvania 18103

United States

Intermountain Healthcare

Salt Lake City, Utah 84103

United States