Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Inadequate treatment of chronic pain is an interrelated public health crisis. An Institute of Medicine Pain Report noted that chronic pain affects ~100 million American adults and costs $635 billion annually. There is a critical need to better integrate behavioral medicine and self-management strate...

Inadequate treatment of chronic pain is an interrelated public health crisis. An Institute of Medicine Pain Report noted that chronic pain affects ~100 million American adults and costs $635 billion annually. There is a critical need to better integrate behavioral medicine and self-management strategies to treat pain comprehensively and apply a 'whole person' approach to pain care. To date, the U.S. lacks scalable behavioral medicine for pain thereby underscoring the need for solutions that are accessible, low-cost, and low-burden. Poor access to behavioral pain care contributes substantially to chronic pain burden because patient-level factors-such as pain catastrophizing-remain untreated and the multidimensional nature of pain ignored. Pain catastrophizing - a pattern of negative cognitive and emotional responses to actual or anticipated pain is a potent prognostic for pain and disability trajectories. Pain catastrophizing is effectively treated with 8-week skills-based group cognitive behavioral therapy for chronic pain (pain-CBT), yet pain-CBT is inaccessible to most Americans due to few trained therapists and the burdens of treatment time and costs. Efficient, effective solutions are urgently needed to provide access to skills-based behavioral medicine that equips patients to reduce pain catastrophizing and better self-manage chronic pain. To address this unmet need, the investigators developed and tested a single-session, 2-hour, pain-CBT skills-based behavioral medicine class ("Empowered Relief") to reduce pain catastrophizing and pain correlates. In a 3-arm randomized controlled trial involving in-person delivery of treatments, results suggest that Empowered Relief was non-inferior to 8-week cognitive behavioral therapy and superior to a health education class for reducing pain catastrophizing and improving multiple secondary outcomes at 3 months post-treatment in individuals with chronic low back pain. In the current study, Empowered Relief is being translated from class delivery to an online format. Implementing a 2-arm randomized controlled trial of a single-session, video conference-based, group-intervention version of "Empowered Relief" and comparing it to Usual Care in mixed etiology chronic pain. Outcome 1, Empowered Relief will be superior to the Usual Care for reducing pain catastrophizing at the 1-month follow-up. Outcome 2, Empowered Relief will be superior to Usual Care for reducing pain bothersomeness and sleep disturbance at the 1-month follow-up. Outcome 3, Empowered Relief will be superior to Usual Care for reducing pain intensity, anxiety, depression, physical function at the 1-month follow-up. Patient outcomes will be longitudinally tracked at weeks 1 & 2 and months 1, 2, & 3 after the intervention session.

Tracking Information

NCT #
NCT04546685
Collaborators
Not Provided
Investigators
Principal Investigator: Beth Darnall, PhD Stanford University