Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study
NCT ID: NCT05612750
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1650 participants
INTERVENTIONAL
2023-01-01
2029-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Lupus Chronic Pain Cohort
150 participants with Lupus and Chronic Pain
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.
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.
Chronic Pelvic Pain
150 participants with Chronic Pelvic Pain
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.
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.
Young Adult (18-23) Chronic Pain
150 participants ages 18-23 with Chronic Pain
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.
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.
PRIME Sample
1200 participants with chronic pain
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Stanford University
OTHER
Responsible Party
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Beth Darnall
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ken Cook, CCRC
Role: primary
Gabby Riazi, MPH
Role: primary
Arayam Hailu, BS
Role: primary
Elizabeth Heggan, BS
Role: primary
Anne Haroldsen
Role: primary
Other Identifiers
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IRB-65439
Identifier Type: -
Identifier Source: org_study_id