NCT05152134

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P50-P75 for phase_3 chronic-pain

Timeline
Completed

Started Aug 2023

Typical duration for phase_3 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

October 7, 2021

Last Update Submit

December 16, 2025

Conditions

Chronic PainOpioid MisuseOpioid Use Disorder

Outcome Measures

Primary Outcomes (31)

  • 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 (Multi-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 (Multi-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 (Multi-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)

Study Arms (2)

Empowered Relief On Demand

EXPERIMENTAL

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

Health Education (HE; "Living Better")

PLACEBO COMPARATOR

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

Interventions

Empowered Relief On-DemandBEHAVIORAL

Tailored interactive digital health treatment for chronic pain

Empowered Relief On Demand
Health EducationBEHAVIORAL

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.

Health Education (HE; "Living Better")

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Edwards KA, Palenski P, Perez L, You DS, Ziadni MS, Jung C, Adair E, Tian L, Mackey SC, Darnall BD. Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study. BMJ Open. 2024 Aug 9;14(8):e086889. doi: 10.1136/bmjopen-2024-086889.

    PMID: 39122392DERIVED

MeSH Terms

Conditions

Chronic PainOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2021

First Posted

December 9, 2021

Study Start

August 23, 2023

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)