Clinical trial NCT05057988: Virtual Empowered Relief for Chronic Pain
Official title: Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single intervention
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Perceived Usefulness
timeFrame: once immediately after class
measure: Participant Satisfaction
timeFrame: once immediately after class
measure: Likelihood of Using the Skills
timeFrame: once immediately after class
Secondary outcomes:
measure: Pain Bothersomeness
timeFrame: At 1 month post-tx
measure: PCS Total Scores
timeFrame: At 1 month post-tx
measure: Pain Intensity
timeFrame: At 1 month post-tx
measure: PROMIS-Sleep Disturbance
timeFrame: At 1 month post-tx
Other outcomes:
measure: PROMIS-Pain Interference
timeFrame: At 1 month post-tx
measure: PROMIS-Depression
timeFrame: At 1 month post-tx
measure: PROMIS-Anxiety
timeFrame: At 1 month post-tx
measure: PROMIS-Physical Function
timeFrame: At 1 month post-tx
measure: Global Impression of Change
timeFrame: At 1 month post-tx
measure: Craving
timeFrame: At 1 month post-tx
Locations:
city: Palo Alto
country: United States
facility: Stanford Pain Relief Innovations Lab
state: California
Study officials:
References:
citation: 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.
citation: 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.
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.
citation: 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.