Digital Therapeutic for Chronic Pain Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control feasibility study with two arms: intervention arm vs. control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>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. | Other: Treatment as usual<br>* 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.<br>|
| Active Comparator: Intervention arm<br>Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual | Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Interference Scale - Short Form 6b | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 (PHQ-9) | depression symptom measure; scores range from 0 to 27; 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) | 
| Generalized Anxiety Disorder 7 (GAD-7) | anxiety symptom measure; scores range from 0-21; 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, primary care, digital therapeutic, mobile app, pain function, pain interference, psychotherapy