Virtual Single-Session "Empowered Relief" Group Intervention for Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Empowered Relief
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18+
- Chronic pain (pain that occurs on at least half of the days of 6 months or more)
- English fluency
- Ability to adhere to and complete study procedures
Exclusion Criteria:
- Cognitive impairment, or non-English speaking.
- Previous participation in the Empowered Relief class.
- On-going legal action or disability claim
Sites / Locations
- 1070 Arastradero Rd
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Usual Care (waitlist)
Single-Session Pain Relief Skills Class (Empowered Relief)
Arm Description
Participants will continue their usual clinical care.
A 2-hour class that will be delivered by a clinical psychologist via videoconference to participant cohorts.
Outcomes
Primary Outcome Measures
Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Empowered Relief will be superior to the Usual Care for reducing pain catastrophizing scores after the intervention.
Secondary Outcome Measures
Pain bothersomeness and PROMIS sleep disturbance
Empowered Relief will be superior to Usual Care for reducing pain bothersomeness and sleep disturbance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04546685
Brief Title
Virtual Single-Session "Empowered Relief" Group Intervention for Chronic Pain
Official Title
Efficacy of a Single-Session "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (waitlist)
Arm Type
Other
Arm Description
Participants will continue their usual clinical care.
Arm Title
Single-Session Pain Relief Skills Class (Empowered Relief)
Arm Type
Experimental
Arm Description
A 2-hour class that will be delivered by a clinical psychologist via videoconference to participant cohorts.
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Waitlist
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empowered Relief
Other Intervention Name(s)
Single-Session Pain Relief Skills Class
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Description
Empowered Relief will be superior to the Usual Care for reducing pain catastrophizing scores after the intervention.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pain bothersomeness and PROMIS sleep disturbance
Description
Empowered Relief will be superior to Usual Care for reducing pain bothersomeness and sleep disturbance
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Pain intensity, PROMIS anxiety, PROMIS depression,PROMIS physical function
Description
Empowered Relief will be superior to Usual Care for reducing pain intensity, anxiety, depression, and physical function
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18+
Chronic pain (pain that occurs on at least half of the days of 6 months or more)
English fluency
Ability to adhere to and complete study procedures
Exclusion Criteria:
Cognitive impairment, or non-English speaking.
Previous participation in the Empowered Relief class.
On-going legal action or disability claim
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Darnall, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
1070 Arastradero Rd
City
Mountain View
State/Province
California
ZIP/Postal Code
94304-1334
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34505832
Citation
Ziadni MS, Gonzalez-Castro L, Anderson S, Krishnamurthy P, Darnall BD. Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. J Med Internet Res. 2021 Sep 10;23(9):e29672. doi: 10.2196/29672.
Results Reference
derived
PubMed Identifier
34022930
Citation
Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
Results Reference
derived
Learn more about this trial
Virtual Single-Session "Empowered Relief" Group Intervention for Chronic Pain
We'll reach out to this number within 24 hrs