Digital Therapeutic for Chronic Pain Feasibility Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06000007
• Other study ID #: STUDY00016340
• Secondary ID: 1R44AT011593-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 25, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Washington Primary Care	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)