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Recruiting Not applicable NCT05612750

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

No applicable phase (e.g. observational)
Conditions: Pain, Chronic Lupus Pelvic Pain

Sponsor: Stanford University

trial.available_in: БГ
Overview
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).
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.
Who can participate
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.
Interventions
Cognitive Behavioral Therapy (CBT)
BEHAVIORAL
Empowered Relief
BEHAVIORAL
Locations 5
United States (5)
Lehigh Valley Health Network
Allentown , Pennsylvania
Elizabeth Heggan, BS
SCAN Health Plan
Long Beach , California
Humana
Louisville , Kentucky
NOT_YET_RECRUITING
Phoenix VA Health Care System
Phoenix , Arizona
NOT_YET_RECRUITING
Intermountain Healthcare
Salt Lake City , Utah
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.01.2023
Completion date
01.05.2029
Registry ID
NCT05612750
Source
clinicaltrials.gov
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