Digital Therapeutic for Chronic Pain Feasibility Study
CompletedPhase 2NCT06000007
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
Study details
- Official title
- Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients With Chronic Pain
- Conditions
- Interventions
- Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app
- Other: Treatment as usual
- Sponsor
- University of Washington
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2023-08-25
- Primary completion
- 2024-07-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * \>=18 years old * at least one ICD pain related diagnosis noted in the electronic health record (EHR) * at least 2 visits in a primary care clinic with at least one in the last 12 months * willing to use a mobile app in English * T-score for the PROMIS brief pain inventory of \>= 55 * access to a smartphone * willing to download and use a mobile app daily Exclusion Criteria: * current cancer related diagnosis (to exclude cancer related chronic pain) * plans for surgery in next 3 months * pregnant * currently receiving hospice care
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06000007