Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Yale University
Chronic kidney disease (CKD) affects approximately 15% of U.S. adults and is associated with elevated rates of anxiety, depression, and diminished quality of life. Mindfulness-based interventions have demonstrated efficacy for psychological well-being in chronic illness populations, but scalable digital delivery models for CKD have not been adequately tested. This single-arm pilot feasibility trial evaluates Calm Health, a HIPAA-compliant digital mindfulness platform, among adults with CKD receiving nephrology care at Yale Medicine or Yale New Haven Hospital. Over 6 weeks, participants will use the app at a recommended dose of 45 minutes per week. They will also wear an Actigraph Leap 2 wrist sensor continuously to capture physical activity, sleep, heart rate, heart rate variability, respiratory rate, skin temperature, and blood pressure trends derived from photoplethysmography (PPG). The primary objectives are to assess feasibility (app engagement minutes per week) and acceptability (satisfaction, appropriateness, and feasibility ratings). Secondary objectives include estimating pre-post effect sizes for mindfulness (FFMQ), self-compassion (SCS), self-efficacy (CDSES), resilience (BRS), perceived stress (PSS-10), kidney disease quality of life (KDQOL-36), and well-being (SWEMWBS). A third objective evaluates participant response to a personalized biometric report integrating app usage, actigraphy, and PPG-derived blood pressure trends, assessed via cognitive interviewing at the final visit. Two structured health coaching check-ins are delivered by a qualified allied health professional - one at Week 1 (troubleshooting and onboarding) and one at Week 4 (motivational interviewing approach). Safety monitoring includes GAD-7 and PHQ-8 administered via the Calm Health app at 4 weeks, with structured follow-up protocols for severe or worsening scores. All study visits are conducted via televideo (Zoom).
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
