Digital Therapeutic for Chronic Pain Feasibility Study

Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients With Chronic Pain

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.

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.

chronic pain, primary care, digital therapeutic, mobile app, pain function, pain interference, psychotherapy

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 includes access to the digital therapeutic mobile app in addition to treatment as usual

2Morrow Chronic Pain Self-Management Program is delivered via a mobile app that engaged patients in evidenced based psychotherapy for chronic pain, including Acceptance and Commitment Therapy and Cognitive Behavioral Therapy based activities, to improve a patient's pain self management. The mobile app also offers the ability to track activities, screen for other problems, support for communicating with medical providers, and access a coach via texting.

Treatment as usual entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.

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

will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)

will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)

will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)

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 will be made upon request after evaluation for appropriateness by principal investigator as an appropriate research request by individuals seeking to do further research. All data will be de-identified to protect participant privacy.

Sharing will occur after the publication of the final outcomes of the study are published and will be available for up to 7 years post completion of data collection.

The requestor must provide acceptable research justification and appropriate permissions from their institutional to use the data requested for specific and detailed research purposes.