NCT05612750

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,650

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jan 2023May 2029

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

August 5, 2022

Last Update Submit

April 15, 2026

Conditions

Pain, ChronicLupusPelvic Pain

Keywords

Young adultLupusPelvic PainBehavioral Health

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (36)

  • Sleep Disturbance

    1 month

  • Sleep Disturbance

    2 months

  • Sleep Disturbance

    3 months

  • Sleep Disturbance

    6 months

  • Pain Bothersomeness

    1 month

  • +31 more secondary outcomes

Other Outcomes (1)

  • Exploratory Outcome Health Service Utilization

    6 months

Study Arms (4)

Lupus Chronic Pain Cohort

EXPERIMENTAL

150 participants with Lupus and Chronic Pain

Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Empowered Relief

Chronic Pelvic Pain

EXPERIMENTAL

150 participants with Chronic Pelvic Pain

Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Empowered Relief

Young Adult (18-23) Chronic Pain

EXPERIMENTAL

150 participants ages 18-23 with Chronic Pain

Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Empowered Relief

PRIME Sample

EXPERIMENTAL

1200 participants with chronic pain

Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Empowered Relief

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.

Chronic Pelvic PainLupus Chronic Pain CohortPRIME SampleYoung Adult (18-23) Chronic Pain
Empowered ReliefBEHAVIORAL

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 PainLupus Chronic Pain CohortPRIME SampleYoung Adult (18-23) Chronic Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age or older of either sex (and all genders).
  • Chronic pain (pain that occurs on at least half of the days of 3 months or more).
  • Past-month average pain intensity score of at least 3/10.
  • Ability to adhere to and complete study protocols.

You may not qualify if:

  • Inability to provide informed consent.
  • Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.
  • Active suicidality at screening.
  • Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.
  • Receipt of either study treatment in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

NOT YET RECRUITING

SCAN Health Plan

Long Beach, California, 90806, United States

RECRUITING

Humana

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

RECRUITING

Intermountain Healthcare

Salt Lake City, Utah, 84103, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41712512DERIVED

MeSH Terms

Conditions

Chronic PainPelvic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Emma A Adair, BS

CONTACT

6097448937eadair@stanford.edu

Corinne Jung, PhD

CONTACT

(650) 724-0522Cejung@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2022

First Posted

November 10, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)