Digital Therapeutic for Chronic Pain Feasibility Study

Phase 3

Completed

Interventions: Other: Treatment as usual
Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	Treatment as usual arm entails the patients continuing to receive care from their primary care provider and any specialists they choose to get involved in their care.
Intervention arm	2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app	Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual

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

Locations (1): University of Washington Primary Care
🇺🇸
Seattle, Washington, United States

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