Trial Outcomes & Findings for Digital Therapeutic for Chronic Pain Feasibility Study (NCT NCT06000007)

Eligibility: aged \>=18, pain experience current and present for \>=3 months, \>=1 ICD code for common pain related condition, \>=2 primary care visits within last 12 months at time of recruitment, PROMIS Pain Interference Short Form 6b T-score \>=55, daily smartphone access, ability to download an app, willingness to engage in a 3-month chronic pain self-management program administered via an app, speak English, and consented. Exclusions: cancer pain surgery within 3 months, pregnant, on hospice.

Patients were invited to participate via direct email with a link to an interest survey with three options: eligibility survey vs request a call back vs opt out. Those eligible were directed to an e-consent form requiring confirmation vs request a call vs confirm that they no interest in participation. Patients who confirmed interest were asked to e-consent. A study coordinator counter-signed the e-consent form and follow up with any call requests, and if needed assist with consent by phone.

Digital Therapeutic for Chronic Pain Feasibility Study

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.

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.

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