Chronic Pain, Opioid Misuse, Opioid Use Disorder
Conditions
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALEmpowered Relief On-Demand
Tailored interactive digital health treatment for chronic pain
BEHAVIORALHealth Education
The HE digital intervention is roughly 65 minutes with content discussing pain and health topics generally; it is devoid of pain education, psychological skills, and has no active strategies, worksheets, or supportive tools.
Sponsors
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | baseline | One validated item assessing average pain intensity for the past 7 days (0= no pain to 10= worst pain imaginable). |
| Pain catastrophizing | baseline | A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = Not at all and 4 = All the time). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing. |
| Pain interference | baseline | 6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = Not at all to 5 = Very much with higher scores representing a greater degree of pain interference. |
| Current prescription opioid misuse | baseline | 17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = never to 4 = very often) with higher scores representing more opioid misuse. |
| Opioid craving | baseline | 1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = no craving to 10 = strongest craving ever). |
| Opioid use | Baseline to post-treatment month 3 | Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD). |
| Treatment engagement | Immediately post-treatment (Primary Outcome) | Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment |
| Treatment appraisal | Immediately post-treatment (Primary Outcome) | 5 items assess satisfaction and perceived utility of assigned treatment (7-point scale where 0 = not at all satisfied to 6 = extremely satisfied). Higher scores indicate higher satisfaction with the assigned treatment. |
Countries
United States
Outcome results
None listed