Mobile & Online-Based Interventions to Lessen Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152134
• Other study ID #: 61643
• Secondary ID: K24DA053564
• Status: Recruiting
• Phase: Phase 3
• Start date: August 23, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Beth Darnall, PhD
• Phone: 650-723-2040
• Email: bdarnall[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Misuse
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• Empowered Relief On-Demand
Tailored interactive digital health treatment for chronic pain
• Health 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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").	baseline
Primary	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
Primary	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
Primary	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 (Multi-Primary Endpoint)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 (Multi-Primary Endpoint)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 (Multi-Primary Endpoint)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	Opioid use	Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).	Baseline to post-treatment month 3
Primary	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)
Primary	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)