Digital Therapeutic for Chronic Pain Feasibility Study

NCT06000007 | Completed Phase 2 Results FDA Device

• 2 other identifiers: STUDY000163401R44AT011593-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; primary care; digital therapeutic; mobile app; pain function; pain interference; psychotherapy

Outcome Measures

Primary Outcomes (1)

• PROMIS Pain Interference Scale - Short Form 6b

  This self-report questionnaire consists of is a six-item that assesses the impact of pain on various aspects of a person's life (e.g., social, cognitive, emotional, physical and recreational activities) over the last 7 days. Responses are scored using a 5-point ordinal rating scale from 1 to 5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Raw score totals are converted to T-score using the scoring manual. T-score of 50 is the mean for the U.S. general population with a standard deviation of 10; the higher the T-score, the worse the pain interference.

  will be measured at baseline, 1-month, 3-month, and 6 month intervals

Secondary Outcomes (2)

• Patient Health Questionnaire 9 (PHQ-9)

  will be measured at baseline, 1-month, 3-month, and 6 month intervals

• Generalized Anxiety Disorder 7 (GAD-7)

  will be measured at baseline, 1-month, 3-month, and 6 month intervals

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

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

Intervention arm

ACTIVE COMPARATOR

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

Interventions

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

Intervention arm

Treatment as usual 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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• current cancer related diagnosis (to exclude cancer related chronic pain)
• plans for surgery in next 3 months
• pregnant
• currently receiving hospice care

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Washington Primary Care

Seattle, Washington, 98116, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kari A. Stephens
• Organization: University of Washington

kstephen@uw.edu

206-221-0349

Study Officials

• Kari A Stephens, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family Medicine

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

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: August 25, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)