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

Stanford University

Status: Enrolling

Conditions: Pelvic Pain; Lupus; Pain, Chronic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05612750

IRB-65439

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,650 participants in 4 patient groups

Lupus Chronic Pain Cohort

Experimental group

Description:

150 participants with Lupus and Chronic Pain

Treatment:

Behavioral: Empowered Relief

Behavioral: Cognitive Behavioral Therapy (CBT)

Chronic Pelvic Pain

Experimental group

Description:

150 participants with Chronic Pelvic Pain

Treatment:

Behavioral: Empowered Relief

Behavioral: Cognitive Behavioral Therapy (CBT)

Young Adult (18-23) Chronic Pain

Experimental group

Description:

150 participants ages 18-23 with Chronic Pain

Treatment:

Behavioral: Empowered Relief

Behavioral: Cognitive Behavioral Therapy (CBT)

PRIME Sample

Experimental group

Description:

1200 participants with chronic pain

Treatment:

Behavioral: Empowered Relief

Behavioral: Cognitive Behavioral Therapy (CBT)