Digital Therapeutic for Chronic Pain Feasibility Study

University of Washington

Status and phase: Completed; Phase 3

Conditions: Chronic Pain

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06000007

STUDY00016340

1R44AT011593-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Treatment as usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual

Intervention arm

Active Comparator group

Description:

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

Treatment:

Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app