Recruiting

CBT vs. Empowered Relief

Sponsor:

Stanford University

Code:

NCT05612750

Conditions

Pain, Chronic

Lupus

Pelvic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy (CBT)

Empowered Relief

Study Details

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).

Conditions

Pain, Chronic

Lupus

Pelvic Pain

Study ID

NCT05612750

Start date

Jan 1, 2023

Status verified date

Apr, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Pain Intensity [ Time Frame: 1 months ]
  • Pain Intensity [ Time Frame: 2 months ]
  • Pain Intensity [ Time Frame: 3 months ]
  • Pain Intensity [ Time Frame: 6 months ]
  • Pain Interference [ Time Frame: 1 month ]
  • Pain Interference [ Time Frame: 2 months ]
  • Pain Interference [ Time Frame: 3 months ]
  • Pain Interference [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Emma A Adair, BS

6097448937eadair@stanford.edu

Corinne Jung, PhD

(650) 724-0522Cejung@stanford.edu

Locations

SCAN Health Plan

Recruiting

Long Beach, California, United States, 90806

Contacts

Gabby Riazi, MPH

(562) 308-5880g.riazi@scanhealthplan.com

Principal Investigator:

Gabrielle Riazi, MPH

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Elizabeth Heggan, BS

elizabeth_a.heggan@lvhn.org

Principal Investigator:

Steve Denton, LCSW

Intermountain Healthcare

Recruiting

Salt Lake City, Utah, United States, 84103

Principal Investigator:

Joel Porter, MD

More Information

Sponsor

Stanford University

Last update posted

May 11, 2026

Last verified

Apr, 2026

Keywords

  • Young adult
  • Lupus
  • Pelvic Pain
  • Behavioral Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-11.