Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic

Maisa S Ziadni, Lluvia Gonzalez-Castro, Steven Anderson, Parthasarathy Krishnamurthy, Beth D Darnall, Maisa S Ziadni, Lluvia Gonzalez-Castro, Steven Anderson, Parthasarathy Krishnamurthy, Beth D Darnall

Abstract

Background: Cognitive behavioral therapy-pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas.

Objective: The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment.

Methods: We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1%) and WLC (54/104, 51.9%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8% clinic patients; 83/101, 82.1% community) who completed at least one study survey: ER (50/101, 49.5%) and WLC (51/104, 49%).

Results: Participants (N=101) were 69.3% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS -8.72, 42.25% reduction; WLC: PCS -2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness.

Conclusions: Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes that was sustained at 3 months. Web-based delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care.

Trial registration: ClinicalTrials.gov NCT04546685; https://ichgcp.net/clinical-trials-registry/NCT04546685.

Keywords: Zoom-delivered; chronic pain; empowered relief; pain catastrophizing; pain intensity; randomized-controlled trial; single-session.

Conflict of interest statement

Conflicts of Interest: Stanford University receives revenue for empowered relief, continuing medical education and instructor certification training provided to health care clinicians. BDD is Chief Science Advisor at AppliedVR and her consulting role with this company (personal fees) is unrelated to the current research. BDD receives royalties for four pain treatment books she has authored or coauthored. BDD is also the principal investigator for a pain research award from the Patient-Centered Research Outcomes Research Institute and pain research grants from the National Institutes of Health. BDD received consultant fees from Axial Healthcare related to physician education for opioid prescribing and deprescribing (2019; unrelated to the current work). BDD serves on the Board of Directors for the American Academy of Pain Medicine and is on the Board of Directors for the Institute for Brain Potential. BDD is a scientific member of the National Institutes of Health Interagency Pain Research Coordinating Committee, the Centers for Disease Control and Prevention Opioid Workgroup and is a member of the Pain Advisory Group of the American Psychological Association.

©Maisa S Ziadni, Lluvia Gonzalez-Castro, Steven Anderson, Parthasarathy Krishnamurthy, Beth D Darnall. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 10.09.2021.

Figures

Figure 1
Figure 1
Participant activities. ER: empowered relief; WLC: waitlist control.
Figure 2
Figure 2
CONSORT (Consolidated Standards of Reporting Trials) flow diagram. ER: empowered relief; ITT: intention-to-treat; WLC: waitlist control.
Figure 3
Figure 3
Pain catastrophizing over time.
Figure 4
Figure 4
Pain intensity over time.
Figure 5
Figure 5
Pain bothersomeness over time.
Figure 6
Figure 6
Sleep disturbance over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 7
Figure 7
Anxiety over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 8
Figure 8
Depression over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 9
Figure 9
Physical function over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 10
Figure 10
Pain interference over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 11
Figure 11
Social isolation over time. PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 12
Figure 12
Anger over time. PROMIS: Patient-Reported Outcomes Measurement Information System.

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Source: PubMed

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