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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Treatment as usual; Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Brennan Keiser, MSW; Phone Number: 206-221-7863; Email: bkeiser@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98116
      • University of Washington Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Treatment as usual; 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.
Active Comparator: Intervention arm; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Kari A Stephens, Ph.D., University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; primary care; psychotherapy; mobile app; digital therapeutic; pain interference; pain function
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: STUDY00016340; 1R44AT011593-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: The requestor must provide acceptable research justification and appropriate permissions from their institutional to use the data requested for specific and detailed research purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No