Virtual Empowered Relief for Chronic Pain

Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine

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.

Study Overview

• Status: Completed
• Conditions: Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Empowered Relief class

Detailed Description

Some patients with chronic pain are on long-term opioid therapy. Methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. Additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (MOUD). It is observed that up to 68% of people with MOUD have chronic pain condition. Therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. Thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. A recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (Empowered Relief; ER) was effective to improve pain and pain-related distress. The ER class consists of pain neuroscience education and self-regulatory skills. While the ER is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. The current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the ER class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 27604
      • Stanford Pain Relief Innovations Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Empowered Relief

Behavioral: Empowered Relief class; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Bothersomeness	How "bothersome" your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness)	At 1 month post-tx
PCS Total Scores	The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing.	At 1 month post-tx
Pain Intensity	How would you rate your pain on average in the past 7 days? (a single item, 0-10 scale, higher scores correspond to greater pain intensity)	At 1 month post-tx
PROMIS-Sleep Disturbance	PROMIS-Sleep Disturbance short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms	At 1 month post-tx

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-Pain Interference	PROMIS-Pain Interference short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms	At 1 month post-tx
PROMIS-Depression	PROMIS-Depression short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms	At 1 month post-tx
PROMIS-Anxiety	PROMIS-Anxiety short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms	At 1 month post-tx
PROMIS-Physical Function	PROMIS-Physical Function short form T Scores Mean = 50, SD = 10 Higher scores indicate better function 30T or higher considers severe impairment	At 1 month post-tx
Global Impression of Change	The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement)	At 1 month post-tx
Craving	How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving)	At 1 month post-tx

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: RTI International

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IRB-60855

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No