Digital Therapeutic for Chronic Pain Feasibility Study

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06000007

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

100

Enrollment

Arms

9.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app Other: Treatment as usual	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control feasibility study with two arms: intervention arm vs. control armRandomized control feasibility study with two arms: intervention arm vs. control arm

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 17, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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