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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
Sponsor:
Information provided by (Responsible Party):
Beth Darnall, Stanford University

Brief Summary:
Pain is naturally aversive and often distressing. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. The purpose of the study is to pilot a single-session videoconference-delivered pain education class (Empowered Relief) for bolstering pain and symptom management in people with chronic pain. Class participants learn skills and develop a personalized plan to use the skills every day. The study will follow participants 3 months by administering 5 follow-up surveys at 1 & 2 weeks and 1 month, 2 months, and 3 months post-treatment to determine whether the class confers long-term benefits across various aspects of health.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Usual Care Behavioral: Empowered Relief Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18+
  2. Chronic pain (pain that occurs on at least half of the days of 6 months or more)
  3. English fluency
  4. Ability to adhere to and complete study procedures

Exclusion Criteria:

  1. Cognitive impairment, or non-English speaking.
  2. Previous participation in the Empowered Relief class.
  3. On-going legal action or disability claim

Information from the National Library of Medicine

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


Locations
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United States, California
1070 Arastradero Rd
Mountain View, California, United States, 94304-1334
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Beth Darnall, PhD Stanford University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beth Darnall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04546685    
Other Study ID Numbers: 31191
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations