Mobile & Online-Based Interventions to Lessen Pain

Study Overview
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Brief Summary
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The investigators will implement a 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
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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, a 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.

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

Conditions
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Opioid Use Disorder, Chronic Pain, Opioid Misuse

Intervention / Treatment
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* Behavioral: Empowered Relief On-Demand
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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 9 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief On Demand<br>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<br>* Tailored interactive digital health treatment for chronic pain<br>|
| Placebo Comparator: Health Education (HE; Living Better)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | One validated item assessing average pain intensity for the past 7 days (0= no pain to 10= worst pain imaginable). | baseline | 
| Pain intensity | One validated item assessing average pain intensity for the past 7 days (0= no pain to 10= worst pain imaginable). | 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). | 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). | post-treatment month 1 (Primary Endpoint) | 
| Pain intensity | One validated item assessing average pain intensity for the past 7 days (0= no pain to 10= worst pain imaginable). | 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). | 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. | 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. | 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. | 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. | post-treatment month 1 (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. | 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. | 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. | 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. | 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. | 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. | post-treatment month 1 (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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | post-treatment months 3 (Secondary Endpoint) | 
| Opioid use | Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD). | 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 | 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. | Immediately post-treatment (Primary Outcome) |