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Completed

NCT Number: NCT05152134

Mobile & Online-Based Interventions to Lessen Pain

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.

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Key information

Conditions

Chronic Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Misuse Opioid Use Disorder Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowered Relief On-Demand

Behavioral

Tailored interactive digital health treatment for chronic pain

Health Education

Behavioral

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.

Primary outcomes

  1. Pain intensity

    Time frame: baseline

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  2. Pain intensity

    Time frame: post-treatment week 1

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  3. Pain intensity

    Time frame: post-treatment week 2

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  4. Pain intensity

    Time frame: post-treatment month 1 (Multi-Primary Endpoint)

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  5. Pain intensity

    Time frame: post-treatment month 2

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  6. Pain intensity

    Time frame: post-treatment month 3

    One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").

  7. Pain catastrophizing

    Time frame: 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.

  8. Pain catastrophizing

    Time frame: post-treatment week 1

    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.

  9. Pain catastrophizing

    Time frame: post-treatment week 2

    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.

  10. Pain catastrophizing

    Time frame: post-treatment month 1 (Multi-Primary Endpoint)

    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.

  11. Pain catastrophizing

    Time frame: post-treatment month 2

    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.

  12. Pain catastrophizing

    Time frame: post-treatment months 3

    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.

  13. Pain interference

    Time frame: 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.

  14. Pain interference

    Time frame: post-treatment week 1

    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.

  15. Pain interference

    Time frame: post-treatment week 2

    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.

  16. Pain interference

    Time frame: post-treatment month 1 (Multi-Primary Endpoint)

    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.

  17. Pain interference

    Time frame: post-treatment month 2

    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.

  18. Pain interference

    Time frame: post-treatment month 3

    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.

  19. Current prescription opioid misuse

    Time frame: 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.

  20. Current prescription opioid misuse

    Time frame: post-treatment month 1 (Primary Endpoint)

    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.

  21. Current prescription opioid misuse

    Time frame: post-treatment month 2

    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.

  22. Current prescription opioid misuse

    Time frame: post-treatment month 3 (Secondary Endpoint)

    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.

  23. Opioid craving

    Time frame: 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").

  24. Opioid craving

    Time frame: post-treatment week 1

    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").

  25. Opioid craving

    Time frame: post-treatment week 2

    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").

  26. Opioid craving

    Time frame: post-treatment month 1 (Primary Endpoint)

    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").

  27. Opioid craving

    Time frame: post-treatment month 2

    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").

  28. Opioid craving

    Time frame: post-treatment months 3 (Secondary Endpoint)

    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").

  29. Opioid use

    Time frame: Baseline to post-treatment month 3

    Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).

  30. Treatment engagement

    Time frame: Immediately post-treatment (Primary Outcome)

    Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment

  31. Treatment appraisal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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