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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Stanford University
Study ID
NCT05612750
Status
Recruiting

Conditions

  • Lupus
  • Pain, Chronic
  • Pelvic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
    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 — BEHAVIORAL
    A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.

Study Details

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).

Key Dates

Start date
Jan 1, 2023
Status verified
Apr 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
1,650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Lupus Chronic Pain Cohort
    150 participants with Lupus and Chronic Pain
  • Experimental: Chronic Pelvic Pain
    150 participants with Chronic Pelvic Pain
  • Experimental: Young Adult (18-23) Chronic Pain
    150 participants ages 18-23 with Chronic Pain
  • Experimental: PRIME Sample
    1200 participants with chronic pain

Primary Outcome Measure

Pain Intensity [ Time Frame: 1 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Phoenix VA Health Care SystemPhoenixArizona85012
Ken Cook, CCRC
602.277.5551
Aram Mardian, MD (PRINCIPAL_INVESTIGATOR)
Eric Hanson, PhD (PRINCIPAL_INVESTIGATOR)
SCAN Health PlanLong BeachCalifornia90806
Gabby Riazi, MPH
(562) 308-5880
Gabrielle Riazi, MPH (PRINCIPAL_INVESTIGATOR)
HumanaLouisvilleKentucky40202
Arayam Hailu, BS
650-887-4497
Jackie Miefert, MS (PRINCIPAL_INVESTIGATOR)
Quanli Chen, MS (SUB_INVESTIGATOR)
Lehigh Valley Health NetworkAllentownPennsylvania18103
Elizabeth Heggan, BS
Steve Denton, LCSW (PRINCIPAL_INVESTIGATOR)
Intermountain HealthcareSalt Lake CityUtah84103
Anne Haroldsen
Joel Porter, MD (PRINCIPAL_INVESTIGATOR)

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