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

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).

Study Overview

• Status: Recruiting
• Conditions: Pelvic Pain; Pain, Chronic; Lupus
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Empowered Relief

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 Type: Interventional
• Enrollment (Estimated): 1650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma A Adair, BS; Phone Number: 6097448937; Email: eadair@stanford.edu
• Study Contact Backup: Name: Corinne Jung, PhD; Phone Number: (650) 724-0522; Email: Cejung@stanford.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Not yet recruiting
      • Phoenix VA Health Care System
      • Principal Investigator: Aram Mardian, MD
      • Principal Investigator: Eric Hanson, PhD
      • Contact: Ken Cook, CCRC; Phone Number: 2451 602.277.5551; Email: arthur.cook@va.gov
  • California
    • Long Beach, California, United States, 90806
      • Recruiting
      • SCAN Health Plan
      • Contact: Gabby Riazi, MPH; Phone Number: 5880 (562) 308-5880; Email: g.riazi@scanhealthplan.com
      • Principal Investigator: Gabrielle Riazi, MPH
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Not yet recruiting
      • Humana
      • Contact: Arayam Hailu, BS; Phone Number: 650-887-4497; Email: arayamyh@stanford.edu
      • Principal Investigator: Jackie Miefert, MS
      • Sub-Investigator: Quanli Chen, MS
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Lehigh Valley Health Network
      • Contact: Elizabeth Heggan, BS; Email: elizabeth_a.heggan@lvhn.org
      • Principal Investigator: Steve Denton, LCSW
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • Recruiting
      • Intermountain Healthcare
      • Contact: Anne Haroldsen
      • Principal Investigator: Joel Porter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lupus Chronic Pain Cohort; 150 participants with Lupus and Chronic Pain	Behavioral: Cognitive Behavioral Therapy (CBT); A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.; Behavioral: Empowered Relief; A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Experimental: Chronic Pelvic Pain; 150 participants with Chronic Pelvic Pain	Behavioral: Cognitive Behavioral Therapy (CBT); A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.; Behavioral: Empowered Relief; A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Experimental: Young Adult (18-23) Chronic Pain; 150 participants ages 18-23 with Chronic Pain	Behavioral: Cognitive Behavioral Therapy (CBT); A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.; Behavioral: Empowered Relief; A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Experimental: PRIME Sample; 1200 participants with chronic pain	Behavioral: Cognitive Behavioral Therapy (CBT); A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.; Behavioral: Empowered Relief; A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	1 months
Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	2 months
Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	3 months
Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	6 months
Pain Interference	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	1 month
Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	2 months
Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	3 months
Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	1 month
Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	2 months
Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	3 months
Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	6 months
Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	1 month
Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	2 months
Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	3 months
Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	6 months
Pain Catastrophizing	Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.	1 months
Pain Catastrophizing	Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.	2 months
Pain 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	3 months
Pain Catastrophizing	Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.	6 months
Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	1 month
Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	2 months
Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	3 months
Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	6 months
Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	1 month
Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	2 months
Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	3 months
Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	6 months
Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	1months
Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	2 month
Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	3 months
Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	6 months
Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	1 month
Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	2 months
Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	3 months
Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	6 months
Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	1 month
Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	2 months
Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	3 months
Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	6 months
Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	1 month
Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	2 months
Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	3 months
Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome Health Service Utilization	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.	6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute

Publications and helpful links

General Publications

• Adair Monson E, Mardian A, Saxena K, Dorsonne B, Hailu AY, Heggan E, Riazi G, Slater K, Poupore-King H, Clifton J, Perez L, Tian L, Porter J, Denton S, Hanson ER, Miefert J, Thorn BE, Mackey SC, Cheung M, Darnall BD. Randomized Comparative Effectiveness Study of 1-Session vs. 8-Session Online Behavioral Treatment for Chronic Pain: Protocol for the national PROGRESS study. Pain Med. 2026 Feb 19:pnag027. doi: 10.1093/pm/pnag027. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lupus; Behavioral Health; Young adult; Pelvic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Pelvic Pain; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: IRB-65439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No