Mobile & Online-Based Interventions to Lessen Pain

February 4, 2024 updated by: Beth Darnall, Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
          • Beth Darnall, PhD
        • Principal Investigator:
          • Beth Darnall, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately post-treatment (Primary Outcome)
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").
baseline
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").
post-treatment week 1
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").
post-treatment week 2
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").
post-treatment month 2
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").
post-treatment month 3
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.
baseline
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.
post-treatment week 1
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.
post-treatment week 2
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.
post-treatment month 2
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.
post-treatment months 3
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.
baseline
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.
post-treatment week 1
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.
post-treatment week 2
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.
post-treatment month 2
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.
post-treatment month 3
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.
baseline
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.
post-treatment month 1 (Primary Endpoint)
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.
post-treatment month 2
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.
post-treatment month 3 (Secondary Endpoint)
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").
baseline
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").
post-treatment week 1
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").
post-treatment week 2
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").
post-treatment month 1 (Primary Endpoint)
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").
post-treatment month 2
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").
post-treatment months 3 (Secondary Endpoint)
Opioid use
Time Frame: Baseline to post-treatment month 3
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Baseline to post-treatment month 3
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.
Immediately post-treatment (Primary Outcome)
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").
post-treatment month 1 (Multi-Primary Endpoint)
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.
post-treatment month 1 (Multi-Primary Endpoint)
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.
post-treatment month 1 (Multi-Primary Endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61643
  • K24DA053564 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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