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

Not Applicable

Recruiting

• Conditions: Pain, Chronic; Lupus; Pelvic Pain
• Interventions: Behavioral: Education

• Registration Number: NCT05612750
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-10
• Study Start: 2023-01-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2029-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1650

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 at screening.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empowered Relief	Education	A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Online 8-session Cognitive Behavioral Therapy	Education	A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	6 months	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference	6 months	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

Secondary Outcome Measures

Name	Time	Method
Pain Bothersomeness	6 months	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Anger	6 months	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Satisfaction with Social Roles/Responsibilities	6 months	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities
Fatigue	6 months	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Sleep Disturbance	6 months	Compare treatment groups on the PROMIS Sleep Disturbance 6-item
Patient Global Impression of Change	6 months	Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Depression	6 months	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.
Pain Catastrophizing	6 months	Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Anxiety	6 months	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item

Trial Locations

Locations (5)

Phoenix VA Health Care System; 🇺🇸 Phoenix, Arizona, United States

SCAN Health Plan; 🇺🇸 Long Beach, California, United States

Humana; 🇺🇸 Louisville, Kentucky, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Intermountain Healthcare; 🇺🇸 Salt Lake City, Utah, United States