Phase 2
Completed N=92
Digital Therapeutic for Chronic Pain Feasibility Study
Source: ClinicalTrials.gov NCT06000007 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: PROMIS Pain Interference Scale - Short Form 6b — 62.1; 62.1; 62.8; 60.8 T-score - difference scores between arms
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PROMIS Pain Interference Scale - Short Form 6b |
62.1; 62.1; 62.8; 60.8; 61.9; 61.2 | — |
| SECONDARY Patient Health Questionnaire 9 (PHQ-9) |
8.2; 8.5; 8.3; 8.7; 8.8; 7.9 | — |
| SECONDARY Generalized Anxiety Disorder 7 (GAD-7) |
6.6; 8.2; 6.9; 8.0; 6.8; 7.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06000007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.