Virtual Empowered Relief for Chronic Pain

• ClinicalTrials.gov Identifier: NCT05057988
• Recruitment Status: Recruiting
• First Posted: September 27, 2021
• Last Update Posted: August 3, 2022
• Sponsor: Stanford University
• Collaborator: RTI International
• Information provided by (Responsible Party): Beth Darnall, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain; Pain	Behavioral: Empowered Relief class	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single intervention
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine
• Actual Study Start Date: September 8, 2021
• Estimated Primary Completion Date: September 30, 2023
• Estimated Study Completion Date: December 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Perceived usefulness/utility [ Time Frame: once immediately after class ]
   How useful was the information presented in the class?
2. Participant satisfaction [ Time Frame: once immediately after class ]
   Please rate your overall satisfaction with the class
3. Likelihood of using the skills [ Time Frame: once immediately after class ]
   How likely are you to use the skills and information you learned?

Secondary Outcome Measures :

1. Pain Bothersomness [ Time Frame: At 1 month post-tx ]
   How "bothersome" your pain had been during the previous week?
2. PCS total scores [ Time Frame: At 1 month post-tx ]
   The Pain Catastrophizing Scale total scores
3. Pain Intensity [ Time Frame: At 1 month post-tx ]
   How would you rate your pain on average in the past 7 days?
4. Sleep disturbance [ Time Frame: At 1 month post-tx ]
   PROMIS-Sleep Disturbance short form T scores

Other Outcome Measures:

1. Pain interference [ Time Frame: At 1 month post-tx ]
   PROMIS-Pain Interference short form T scores
2. Depression [ Time Frame: At 1 month post-tx ]
   PROMIS-Depression short form T scores
3. Anxiety [ Time Frame: At 1 month post-tx ]
   PROMIS-Anxiety short form T scores
4. Physical Function [ Time Frame: At 1 month post-tx ]
   PROMIS-Physical Function short form T Scores
5. Global Impression of change [ Time Frame: At 1 month post-tx ]
   The global impression of change
6. Craving [ Time Frame: At 1 month post-tx ]
   How much do you crave opiates now?

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Dokyoung S You, PhD; 650-724-9320; dsyou@stanford.edu

Locations

United States, California

Stanford Pain Relief Innovations Lab; Recruiting

Palo Alto, California, United States, 27604

Contact: Dokyoung S You, PhD

Sponsors and Collaborators

Stanford University

RTI International

More Information

Publications:

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.

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.

• Responsible Party: Beth Darnall, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05057988
• Other Study ID Numbers: IRB-60855
• First Posted: September 27, 2021
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations