Mobile & Online-Based Interventions to Lessen Pain
NCT05152134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234
Last updated 2025-12-18
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.
Conditions
- Chronic Pain
- Opioid Misuse
- Opioid Use Disorder
Interventions
- BEHAVIORAL
-
Empowered Relief On-Demand
Tailored interactive digital health treatment for chronic pain
- 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.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-23
- Primary Completion
- 2025-08-15
- Completion
- 2025-08-15
Countries
- United States
Study Locations
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