A Phase 3 interventional study of Empowered Relief On-Demand and Health Education in Chronic Pain, Opioid Misuse and Opioid Use Disorder, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Stanford University · Phase 3, Interventional, and Treatment
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 234 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Empowered Relief On-Demand
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.
Behavioral: Health Education
Tailored interactive digital health treatment for chronic pain
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.
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: baseline
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: post-treatment week 1
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: post-treatment week 2
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: post-treatment month 2
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time frame: post-treatment month 3
Pain catastrophizing
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.
Time frame: baseline
Pain catastrophizing
A brief 4-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 0-16 with higher scores indicating higher levels of pain catastrophizing.
Time frame: post-treatment week 1
Pain catastrophizing
A brief 4-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 0-16 with higher scores indicating higher levels of pain catastrophizing.
Time frame: post-treatment week 2
Pain catastrophizing
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.
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
Pain catastrophizing
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.
Time frame: post-treatment month 2
Pain catastrophizing
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.
Time frame: post-treatment months 3
Pain interference
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.
Time frame: baseline
Pain interference
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.
Time frame: post-treatment week 1
Pain interference
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.
Time frame: post-treatment week 2
Pain interference
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.
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
Pain interference
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.
Time frame: post-treatment month 2
Pain interference
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.
Time frame: post-treatment month 3
Current prescription opioid misuse
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.
Time frame: baseline
Current prescription opioid misuse
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.
Time frame: post-treatment month 1 (Primary Endpoint)
Current prescription opioid misuse
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.
Time frame: post-treatment month 2
Current prescription opioid misuse
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.
Time frame: post-treatment month 3 (Secondary Endpoint)
Opioid craving
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").
Time frame: baseline
Opioid craving
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").
Time frame: post-treatment week 1
Opioid craving
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").
Time frame: post-treatment week 2
Opioid craving
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").
Time frame: post-treatment month 1 (Primary Endpoint)
Opioid craving
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").
Time frame: post-treatment month 2
Opioid craving
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").
Time frame: post-treatment months 3 (Secondary Endpoint)
Opioid use
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Time frame: Baseline to post-treatment month 3
Treatment engagement
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
Time frame: Immediately post-treatment (Primary Outcome)
Treatment appraisal
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.
Time frame: Immediately post-treatment (Primary Outcome)
Plan to share: No
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