Chronic Kidney DiseaseNCT07541495
The Mindful Kidney: Supporting Mindfulness for Adults With Chronic Kidney Disease
A study testing Mindfulness in people with Chronic Kidney Disease, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06525
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Kidney Disease
- Being tested
- Mindfulness
- Keywords
- Mindfulness, Mobile phone, Mobile health, Health coaching
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start29 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garrett I Ash, PhD, Yale University
- Investigators
- Garrett I Ash, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541495
- Sponsor's protocol ID
- 2000042104
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mindful Kidney: A Digital Mindfulness Intervention for Adults With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07541495
- Acronym / sponsor ID
- 2000042104
- Conditions
- Chronic Kidney Disease
- Keywords
- Mindfulness, Mobile phone, Mobile health, Health coaching
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessMindfulness support | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Perceived Stress Scale (PSS-10) Score
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Garrett I Ash, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Chronic Kidney Disease, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness App Engagement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.