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Completed

NCT Number: NCT06000007

Digital Therapeutic for Chronic Pain Feasibility Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington Primary Care

Seattle, Washington, 98116, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. PROMIS Pain Interference Scale - Short Form 6b

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

    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.

Secondary outcomes

  1. Patient Health Questionnaire 9 (PHQ-9)

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

    This self-report questionnaire consists of 9 items assessing depressive symptoms consistent with criteria for Major Depressive Disorder over the past two weeks. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day).

    Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome). A typical cut-off score for probable depression is ≥ 10 points.

    The measure has demonstrated strong psychometric properties, including high levels of sensitivity and specificity for identifying major depressive disorder.

  2. Generalized Anxiety Disorder 7 (GAD-7)

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

    anxiety symptom measure; scores range from 0-21; higher scores are worse

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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