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

Last updated: November 12, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus

Pain

Dysmenorrhea (Painful Periods)

Treatment

Cognitive Behavioral Therapy (CBT)

Empowered Relief

Clinical Study ID

NCT05612750
IRB-65439
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Inability to provide informed consent.

  2. Cognitive impairment, non-English speaking, or psychological factors that wouldpreclude comprehension of material and/or full participation in the study includinggroup treatment.

  3. Active suicidality at screening.

  4. Study staff may exclude individuals with a known history of disruptive behavior tominimize contamination of the learning environment for an entire treatment cohort.

  5. Receipt of either study treatment in the past 3 months.

Study Design

Total Participants: 1650
Treatment Group(s): 2
Primary Treatment: Cognitive Behavioral Therapy (CBT)
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
May 01, 2029

Study 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.

Connect with a study center

  • Phoenix VA Health Care System

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • SCAN Health Plan

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Humana

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • Intermountain Healthcare

    Salt Lake City, Utah 84103
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.