Virtual Empowered Relief for Chronic Pain

NCT05057988 | Completed Results

• 1 other identifier: IRB-60855
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

Conditions

Chronic Pain; Pain

Outcome Measures

Primary Outcomes (3)

• Perceived Usefulness

  How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness).

  once immediately after class

• Participant Satisfaction

  Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction).

  once immediately after class

• Likelihood of Using the Skills

  How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood)

  once immediately after class

Secondary Outcomes (4)

• Pain Bothersomeness

  At 1 month post-tx

• PCS Total Scores

  At 1 month post-tx

• Pain Intensity

  At 1 month post-tx

• PROMIS-Sleep Disturbance

  At 1 month post-tx

Other Outcomes (6)

• PROMIS-Pain Interference

  At 1 month post-tx

• PROMIS-Depression

  At 1 month post-tx

• PROMIS-Anxiety

  At 1 month post-tx

Study Arms (1)

Empowered Relief

EXPERIMENTAL

Behavioral: Empowered Relief class

Interventions

Empowered Relief class BEHAVIORAL

The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for 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.

Empowered Relief

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years old
• Chronic Pain (\> 3 months)
• Taking Methadone or Buprenorphine
• English Fluency

You may not qualify if:

• Pregnant,
• Gross Cognitive Impairment,
• Acute Suicidality,
• Severe Depression

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pain Relief Innovations Lab

Palo Alto, California, 27604, United States

Location

Related Publications (4)

• Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739. doi: 10.1001/jamanetworkopen.2022.9739.

  PMID: 34398206 BACKGROUND

• Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014.

  PMID: 24851056 BACKGROUND

• 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.

  PMID: 34022930 BACKGROUND

• Klein MR, Darnall BD, You DS. Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial. JMIR Res Protoc. 2024 Jun 6;13:e53784. doi: 10.2196/53784.

  PMID: 38843513 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Dokyoung Sophia You
• Organization: Stanford University

dsyou@stanford.edu

650-724-9320

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single intervention

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: September 8, 2021
• Primary Completion: October 23, 2023
• Study Completion: February 2, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Locations

US (1)