Digital Therapeutic for Chronic Pain Feasibility Study

Phase 3

Completed

• Conditions: Chronic Pain

• Registration Number: NCT06000007
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, 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 Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-21
• Study Start: 2023-08-25
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PROMIS Pain Interference Scale - Short Form 6b	will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)	Brief survey of patient's perceived pain interference in their ability to function; scores are normed on a T-score with 50 as the mean, 10 as the standard deviation, and higher scores are worse

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9 (PHQ-9)	will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)	depression symptom measure; scores range from 0 to 27; higher scores are worse
Generalized Anxiety Disorder 7 (GAD-7)	will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)	anxiety symptom measure; scores range from 0-21; higher scores are worse

Trial Locations

Locations (1)

University of Washington Primary Care; 🇺🇸 Seattle, Washington, United States