Mobile & Online-Based Interventions to Lessen Pain

Stanford University

Status and phase: Enrolling; Phase 3

Conditions: Opioid Use Disorder; Chronic Pain; Opioid Misuse

Treatments: Behavioral: Health Education; Behavioral: Empowered Relief On-Demand

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05152134

61643

K24DA053564 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators will implement an international 2-arm online pragmatic feasibility randomized controlled trial (RCT) of a digital pain relief skills intervention "Empowered Relief: On-Demand" to reduce pain metrics, opioid craving, and opioid misuse. They will compare Empowered Relief to a no-skills digital health education ("Living Better") intervention in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.

Full description

Most people who misuse prescription opioids report doing so for pain relief. This study will investigate a digital intervention for people with comorbid chronic pain and opioid misuse.

The intervention, Empowered Relief On-Demand, will include roughly 80 minutes of interactive digital pain education and pain management skills content with multimedia features and an App. The investigators will conduct a fully online 2-arm RCT of digital Empowered Relief in a national sample of people with comorbid chronic pain and opioid misuse compared to a digital health education control (HE).

The investigators will implement The MOBILE Relief Study, an international (United States, Canada, United Kingdom, and Australia) 2-arm online feasibility RCT of Empowered Relief to reduce pain intensity, pain interference, pain-related distress (pain outcomes) and opioid outcomes (opioid craving and misuse) in people with prescription opioid misuse and chronic pain. They will compare Empowered Relief On Demand to an interactive digital health education (HE) intervention that is devoid of pain management skills ("Living Better") in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey (received immediately following treatment completion) is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with five items (overall satisfaction with treatment, ease of understanding, relevance, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, and months 1, 2, and 3. At post-treatment weeks 1 and 2, electronic surveys will measure opioid craving, pain intensity, pain catastrophizing (distress), and pain interference.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and females 18 years of age or older
• Chronic non-cancer pain (at least 6 months in duration)
• Average pain intensity of at least 3 on the PROMIS SFV1.0 Pain Intensity 1a
• Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
• Opioid misuse (at least 6 on the Current Opioid Misuse Measure; COMM)
• English fluency
• Internet access

Exclusion criteria

• Gross cognitive impairment
• Inability to complete study electronic surveys
• Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Empowered Relief On Demand

Experimental group

Description:

Empowered Relief On-Demand will include roughly 80 minutes of interactive and multimedia pain educational content that targets pain and stress self-regulation, pain medication misuse, a personalized plan for relief and an audio App for daily use.

Treatment:

Behavioral: Empowered Relief On-Demand

Health Education (HE; "Living Better")

Placebo Comparator group

Description:

The HE arm is an interactive digital general health education intervention called "Living Better" that is devoid of specific content on pain, psychological skills, and has no active strategies or worksheets.

Treatment:

Behavioral: Health Education