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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05612750
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain, Chronic, Lupus, Pelvic Pain

Additional Details

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.

Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix VA Health Care System, Phoenix, Arizona

Status

Not yet recruiting

Address

Phoenix VA Health Care System

Phoenix, Arizona, 85012

Site Contact

Ken Cook, CCRC

[email protected]

602.277.5551 #2451

SCAN Health Plan, Long Beach, California

Status