Virtual Single-Session "Empowered Relief" Group Intervention for Chronic Pain
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|ClinicalTrials.gov Identifier: NCT04546685|
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : July 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Other: Usual Care Behavioral: Empowered Relief||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of a Single-Session "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain|
|Actual Study Start Date :||September 28, 2020|
|Actual Primary Completion Date :||July 7, 2021|
|Actual Study Completion Date :||July 7, 2021|
Usual Care (waitlist)
Participants will continue their usual clinical care.
Other: Usual Care
Participants who are randomized in the waitlist or usual care do not receive the study intervention and will be instructed to continue with the care they would normally receive as part of their ongoing clinical care. Upon completion of the 3-month study, participants in the waitlist will be invited to enroll in the Empowered Relief class.
Other Name: Waitlist
Experimental: Single-Session Pain Relief Skills Class (Empowered Relief)
A 2-hour class that will be delivered by a clinical psychologist via videoconference to participant cohorts.
Behavioral: Empowered Relief
The participants will attend the Empowered Relief class offered online via Zoom. The class is designed to treat pain catastrophizing in people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
Other Name: Single-Session Pain Relief Skills Class
- Pain Catastrophizing Score; measured with Pain Catastrophizing Scale [ Time Frame: 1 month ]Empowered Relief will be superior to the Usual Care for reducing pain catastrophizing scores after the intervention.
- Pain bothersomeness and PROMIS sleep disturbance [ Time Frame: 1 month ]Empowered Relief will be superior to Usual Care for reducing pain bothersomeness and sleep disturbance
- Pain intensity, PROMIS anxiety, PROMIS depression,PROMIS physical function [ Time Frame: 1 month ]Empowered Relief will be superior to Usual Care for reducing pain intensity, anxiety, depression, and physical function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546685
|United States, California|
|1070 Arastradero Rd|
|Mountain View, California, United States, 94304-1334|
|Principal Investigator:||Beth Darnall, PhD||Stanford University|