The Mindful Kidney: Supporting Mindfulness for Adults With Chronic Kidney Disease

N/AEnrolling By InvitationNCT07541495

Yale University26 enrolled

Overview

This study tests a digital mindfulness app called Calm Health among adults with chronic kidney disease (CKD). Participants will use the app for 6 weeks while wearing a wrist sensor that tracks sleep, physical activity, heart rate, and other health signals. The study will measure how acceptable and feasible the app is, and whether it may improve stress, anxiety, and quality of life. Participants will also receive health coaching and a personalized report showing how their mindfulness practice relates to their health data.

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).

Study Type

INTERVENTIONAL

Allocation

Conditions

Chronic Kidney Disease

Interventions

MindfulnessBEHAVIORAL

Mindfulness support

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 to 80 years * Diagnosed with chronic kidney disease (CKD) for at least 6 months with at least two consecutive nephrology visits within the past year * Receiving CKD care at Yale Medicine Nephrology or Yale New Haven Hospital * Able to use a smartphone (study team will provide one if needed) * Able to read and write English Exclusion Criteria: * Current meditation or mindfulness practice meeting or exceeding 70 minutes per week over the past month * New or unstable psychopharmaceutical treatment in the past 2 months (stable maintenance therapy with no dose or medication changes for 8 or more weeks is acceptable) * Current intensive psychiatric treatment, defined as psychiatric hospitalization in the past 6 months, intensive outpatient program, or inpatient rehabilitation * Current or planned pregnancy in the next 6 months * Average resting blood pressure exceeding 160/100 mmHg based on readings available in the medical record, with reconfirmation by additional readings prior to exclusion if only an isolated reading in this range is available

Locations (1)

Yale School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Mindfulness App Engagement

Mean minutes per week of Calm Health app use, measured objectively via app backend usage logs across the 6-week intervention period. Feasibility is defined a priori as average engagement ≥45 minutes per week. There is no scale; outcome is reported as continuous minutes per week.

Time frame: 6 weeks

Secondary Outcomes

Perceived Stress Scale (PSS-10) Score

The PSS-10 is a 10-item validated self-report measure of perceived stress over the past month. Each item is rated on a 5-point scale (0 = Never to 4 = Very often); 4 items are reverse-scored. Total score ranges from 0 to 40, with higher scores indicating greater perceived stress. Pre-post change score (6-week minus baseline) is reported.

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.