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

April 22, 2026 updated by: Garrett I Ash, PhD, Yale University

The Mindful Kidney: A Digital Mindfulness Intervention for Adults With Chronic Kidney Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06525
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Behavioral: Mindfulness
Mindfulness support

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mindfulness App Engagement
Time Frame: 6 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS-10) Score
Time Frame: Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Garrett I Ash, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000042104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Study Data/Documents

  1. Study Protocol
  2. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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