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

NCT07541495 | Enrolling By Invitation

• 1 other identifier: 2000042104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

Mindfulness; Mobile phone; Mobile health; Health coaching

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• Perceived Stress Scale (PSS-10) Score

  Baseline and 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Mindfulness support

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06525, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Garrett I Ash, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Biomedical Informatics, and Data Science

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (1)