Mobile & Online-Based Interventions to Lessen Pain
Primary Purpose
Chronic Pain, Opioid Misuse, Opioid Use Disorder
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Empowered Relief On-Demand
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Male and females 18 years of age or older
- Chronic non-cancer pain (at least 6 months in duration)
- 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
- Email access
Exclusion Criteria:
- Gross cognitive impairment
- Current medicolegal factors (open disability claim)
- Inability to complete study electronic surveys
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Empowered Relief On Demand
Health Education (HE; "Living Better")
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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").
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").
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").
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").
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").
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").
Opioid use
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Treatment engagement
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05152134
First Posted
October 7, 2021
Last Updated
August 23, 2023
Sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05152134
Brief Title
Mobile & Online-Based Interventions to Lessen Pain
Official Title
Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Misuse, Opioid Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empowered Relief On Demand
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education (HE; "Living Better")
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empowered Relief On-Demand
Intervention Description
Tailored interactive digital health treatment for chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Time Frame
baseline
Title
Pain intensity
Description
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
Title
Pain intensity
Description
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
Title
Pain intensity
Description
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 (Primary Endpoint)
Title
Pain intensity
Description
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
Title
Pain intensity
Description
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
Title
Pain catastrophizing
Description
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
Title
Pain catastrophizing
Description
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
Title
Pain catastrophizing
Description
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
Title
Pain catastrophizing
Description
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 (Primary Endpoint)
Title
Pain catastrophizing
Description
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
Title
Pain catastrophizing
Description
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
Title
Pain interference
Description
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
Title
Pain interference
Description
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
Title
Pain interference
Description
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
Title
Pain interference
Description
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 (Primary Endpoint)
Title
Pain interference
Description
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
Title
Pain interference
Description
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
Title
Current prescription opioid misuse
Description
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
Title
Current prescription opioid misuse
Description
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)
Title
Current prescription opioid misuse
Description
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
Title
Current prescription opioid misuse
Description
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)
Title
Opioid craving
Description
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
Title
Opioid craving
Description
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
Title
Opioid craving
Description
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
Title
Opioid craving
Description
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)
Title
Opioid craving
Description
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
Title
Opioid craving
Description
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)
Title
Opioid use
Description
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Time Frame
Baseline to post-treatment month 3
Title
Treatment engagement
Description
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)
Title
Treatment appraisal
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Darnall, PhD
Phone
650-723-2040
Email
bdarnall@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Corinne Jung, PhD
Phone
650-724-0522
Email
cejung@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Darnall, PhD
First Name & Middle Initial & Last Name & Degree
Beth Darnall, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile & Online-Based Interventions to Lessen Pain
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