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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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 entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.
University of Washington Primary Care
Seattle, Washington, United States
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.
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Patient Health Questionnaire 9 (PHQ-9)
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.
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Generalized Anxiety Disorder 7 (GAD-7)
anxiety symptom measure; scores range from 0-21; higher scores are worse
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
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