Digital Therapeutic for Chronic Pain Feasibility Study

NCT ID: NCT06000007

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2024-07-30

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.

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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.

Intervention arm

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kari Stephens

Professor of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari A Stephens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Primary Care

Seattle, Washington, United States

Countries

United States

References

Stephens, K. A., Ma, K., Keiser, B., Prado, M., Zhang, Y., West, I., Hsu, C., Anastas, T., Zbikowski, S., Waters, D., & Masterson, J. (2024, August). Improving chronic pain through use of a digital behavioral health app. Abstract and poster presented at the American Psychological Association Annual Convention, Seattle, WA.

Reference Type: BACKGROUND

Other Identifiers

1R44AT011593-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00016340

Identifier Type: -

Identifier Source: org_study_id