The Mindful Kidney: A Digital Mindfulness Intervention for Adults With Chronic Kidney Disease
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: Yale University

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The Mindful Kidney: A Digital Mindfulness Intervention for Adults 
with Chronic Kidney Disease
Protocol Number
2000042104
Protocol Version
April 10, 2026
Version #2
Clinical Trials Registration Number: Trial to be registered on ClinicalTrials.gov before first participant 
enrolled.
INVESTIGATORS:
Garrett Ash, PhD (principal investigator)
Internal Medicine
203-444-3079
Garrett.ash@yale.edu
Menaka Sarav, MD (co-investigator)
Internal Medicine
Menaka.sarav@yale.edu
Confidentiality Statement:
Participant confidentiality and privacy is strictly held in confidence by the participating 
investigators, their staff, and sponsors. Therefore, the study protocol, documentation, data, and 
all other information generated will be held in strict confidence, except where required by U.S. 
law (e.g., knowledge of abuse of a child or elderly person). The study will not obtain a certificate 
of confidentiality since none of the collected data will be sensitive enough to warrant one.
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Synopsis
Purpose
Mindfulness is a cognitive skill focused on maintaining moment-to-moment 
awareness of one’s internal state and surroundings. Limited evidence exists on 
digital mindfulness interventions for adults with chronic kidney disease (CKD). This 
pilot study will evaluate the feasibility, acceptability, and preliminary efficacy of 
Calm Health, a commercial mindfulness mobile application, among adults with 
CKD.
Objectives
Objective #1: Determine whether it is feasible and acceptable to use Calm Health 
among adults with CKD. 
Objective #2: Determine whether using Calm Health has favorable effects upon 
perceived stress, quality of life, well-being, mental health, and blood pressure. 
Objective #3: Develop visualizations of biometric data and mindfulness app usage 
timestamps, to help adults with CKD review and understand their health data and 
refine reports by a user-centered design.
Study Population
Adults aged 18 years and older diagnosed with CKD for at least 6 months with at 
least two consecutive nephrology visits within a 1 year window, the last occurring 
within the past year. They will be patients of Yale Medicine Nephrology or Yale 
New Haven Hospital.
Number of Participants
26
Study Design
This is a prospective, non-randomized, single-arm pilot clinical trial to evaluate the 
feasibility, acceptability, and efficacy signal of the Calm Health app among adults 
with CKD.
Study Duration
Individual participant duration: recruitment to baseline visit will take 1–30 days, and 
baseline visit to end of follow-up will take 6 weeks, for a total duration of 
approximately 2.5 months. The cutoff date for enrollment will be October 15, 2026 
so that each participant can complete the 6 weeks of app access before the accounts 
expire on November 30, 2026. The period from December 2026 – March 2027 has 
been allocated for data analysis and dissemination. Total study duration: 1 year 
(April 15, 2026 – March 31, 2027).
Outcome Variables
Primary: Mindfulness app usage minutes, implementation outcome measures 
(acceptability, appropriateness, feasibility), net promoter score, semi-structured 
interviews.  
Secondary: Five Facet Mindfulness Questionnaire, Self-Compassion Scale, Chronic 
Disease Self-Efficacy Scale, Brief Resilience Scale, Perceived Stress Scale (PSS-
10), Kidney Disease Quality of Life (KDQOL-36), Short Warwick-Edinburgh 
Mental Well-Being Scale, Generalized Anxiety Disorder 7 (GAD-7), Patient Health 
Questionnaire 8 (PHQ-8), blood pressure.
Locations/Facilities
Yale School of Medicine, New Haven, CT (data collection) 
Yale New Haven Hospital, New Haven, CT (recruitment) 
Yale Medicine Nephrology, Stamford, CT (recruitment)
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Abbreviations
Abbreviation
Explanation
AE
Adverse event
BRS
Brief Resilience Scale
CDSES
Chronic Disease Self-Efficacy Scale
CKD
Chronic kidney disease
CSV
Comma-separated values (format of export file)
eGFR
Estimated glomerular filtration rate
FFMQ
Five Facet Mindfulness Questionnaire
GAD-7
Generalized Anxiety Disorder 7-Question Assessment
IRES
Integrated Research Enterprise Solution (hosts IRB protocols)
KDQOL-36
Kidney Disease Quality of Life 36-Item Short Form
MBSR
Mindfulness-Based Stress Reduction
PHQ-8
Patient Health Questionnaire 8-Question Assessment for Depression
PSS-10
Perceived Stress Scale (10-item)
SCS
Self-Compassion Scale
SWEMWBS
Short Warwick-Edinburgh Mental Well-Being Scale
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Glossary of Terms
Term
Explanation
Mindfulness
A cognitive skill focused on maintaining moment-to-moment awareness of one’s 
internal state and surroundings.
Chronic Kidney 
Disease
A condition characterized by gradual loss of kidney function over time, classified by 
stages based on estimated glomerular filtration rate (eGFR).
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Table of Contents
1  Background..................................................................................................................................8
1.1  Background...........................................................................................................................8
1.2  Prior Experience ...................................................................................................................9
2  Rationale/Significance...............................................................................................................10
2.1  Rationale and Study Significance.......................................................................................10
2.2  Risks ...................................................................................................................................10
2.3  Anticipated Benefits ...........................................................................................................11
3  Study Purpose and Objectives ...................................................................................................12
3.1  Purpose ...............................................................................................................................12
3.2  Hypotheses..........................................................................................................................12
3.3  Objectives ...........................................................................................................................12
4  Study Design..............................................................................................................................12
4.1  Study Duration....................................................................................................................13
4.2  Outcome Variables/Endpoints............................................................................................13
4.2.1  Primary Outcome Variables/Endpoints .......................................................................13
4.2.2  Secondary and Exploratory Outcome Variables/Endpoints ........................................13
5  Study Participants ......................................................................................................................14
5.1  Study Population.................................................................................................................14
5.2  Number of Participants.......................................................................................................15
5.3  Eligibility Criteria...............................................................................................................15
5.4  Recruitment Procedures......................................................................................................16
5.5  Consent/Assent Procedures/HIPAA Authorization............................................................16
6  Study Methods/Procedures ........................................................................................................17
6.1  Study Procedures ................................................................................................................17
6.1.1  Data Collection ............................................................................................................18
6.2  Method of Assignment/Randomization..............................................................................18
6.3  Adverse Events Definition and Reporting..........................................................................18
6.4  Reaction Management ........................................................................................................18
6.5  Withdrawal Procedures.......................................................................................................18
6.6  Locations/Facilities.............................................................................................................19
7  Statistical Design .......................................................................................................................19
7.1  Sample Size Considerations ...............................................................................................19
7.2  Planned Analyses................................................................................................................19
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7.2.1  Secondary Objective Analyses ....................................................................................19
7.2.2  Analysis of Subject Characteristics .............................................................................19
7.2.3  Interim Analysis...........................................................................................................20
7.3  Data Relevance ...................................................................................................................20
7.4  Data Coding........................................................................................................................20
7.5  Data Analysis Tools............................................................................................................20
7.6  Data Monitoring..................................................................................................................20
7.7  Handling of Missing Data...................................................................................................20
8  Data/Specimen Handling and Record Keeping .........................................................................20
8.1  Subject Data Confidentiality...............................................................................................21
8.2  Data Quality Assurance ......................................................................................................22
8.3  Data or Specimen Storage/Security....................................................................................22
8.4  Study Records.....................................................................................................................22
8.5  Access to Source.................................................................................................................22
8.6  Retention of Records ..........................................................................................................22
8.7  Data and Safety Monitoring Plan .......................................................................................22
9  Study Considerations.................................................................................................................23
9.1  Institutional Review Board (IRB) Review .........................................................................23
9.2  Research Personnel Training ..............................................................................................23
9.3  Study Monitoring................................................................................................................23
9.4  Unanticipated Problems and Protocol Deviations ..............................................................23
9.5  Study Discontinuation ........................................................................................................24
9.6  Study Completion ...............................................................................................................24
9.7  Conflict of Interest Management Plan................................................................................24
9.8  Funding Source...................................................................................................................24
9.9  Publication Plan..................................................................................................................24
10  Appendices ..............................................................................................................................24
11  List of Tables ...........................................................................................................................25
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Protocol Revision History
Version Date
Summary of Substantial Changes
March 8, 2026
Original version
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1  Background
1.1  Background
Chronic kidney disease (CKD) and mental health. CKD is a progressive condition affecting 
an estimated 37 million adults in the United States. A global systematic review and meta-
analysis of 65 studies (80,932 individuals with CKD) found an overall pooled depression 
prevalence of 26.5% (95% CI 23.1–30.1%), with higher rates among those on chronic 
hemodialysis compared to pre-dialysis patients (29.9% vs. 18.5%; p=0.01)1. Anxiety rates are 
similarly elevated, with one study finding clinically significant anxiety in 50.7% and depression 
in 35.4% of participants across CKD stages, using the Hospital Anxiety and Depression Scale2. 
Notably, 26.4% of CKD patients in that study had experienced suicidal ideation and 9.3% had 
attempted suicide2. Depression and anxiety in CKD are associated with lower health-related 
quality of life, poorer treatment adherence, increased hospitalizations, and higher mortality1,2. 
Despite these risks, mental health treatment engagement remains low among adults with CKD 
due to barriers such as time demands of medical management (including dialysis schedules), 
transportation constraints, stigma, and limited access to specialists with nephrology-specific 
expertise2,3.
Mindfulness interventions for CKD. Mindfulness, a cognitive skill focused on maintaining 
moment-to-moment awareness of one’s internal state and surroundings, is typically acquired 
through meditation practice. A systematic review of mind-body interventions in pre-dialysis 
CKD analyzed 32 RCTs and found anxiety reductions of 8–44% with various modalities (music 
therapy, relaxation therapy, spiritual therapy), with no adverse effects reported4. Among patients 
on dialysis, systematic reviews of mindfulness-based interventions have found promising 
improvements in depression, anxiety, stress, sleep, and quality of life5–8. A recent systematic 
review of psycho-behavioural interventions in CKD patients not yet on dialysis (5 RCTs, 
N=631) found moderate-certainty evidence of consistent improvements in self-efficacy and 
physical function, with emerging evidence for mental health benefits9.
A landmark RCT by Jeong et al. (2025) randomized 29 patients with CKD stages III–IV to an 8-
week Mindfulness-Based Stress Reduction (MBSR) program versus a Health Enhancement 
Program. Using direct intraneural recordings of muscle sympathetic nerve activity (MSNA), the 
study found a significant reduction in sympathetic reactivity during mental stress (p=0.029) with 
a large effect size (Hedges’ g = −0.858)10. An earlier acute study in 15 hypertensive African-
American males with CKD demonstrated that a single 14-minute guided mindfulness session 
lowered both sympathetic nerve activity and blood pressure compared to a control condition11. 
These findings establish unique sympathoinhibitory effects of mindfulness beyond simple 
breathing modifications, with direct relevance to the cardiovascular complications of CKD.
Digital delivery of mindfulness. Digital mindfulness interventions offer several advantages for 
CKD populations, including increased accessibility, scalability, cost-effectiveness, and sustained 
contact over an extended period of time. Calm Health is an evidence-based and affordable 
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($6/month) commercial mobile health application rooted in mindfulness. Four fully powered 
randomized controlled trials support the effectiveness of the Calm app in reducing mental health 
symptoms across different populations12–15 and improving clinical benefits for other underlying 
conditions13,14. We recently partnered with Calm Health to create a CKD-specific module of 
mindfulness exercises as an unpaid consultant (Co-I Dr. Griffith). This module, combined with 
their other modules for general mindfulness and mental health, could be an effective and 
implementable tool for CKD distress.
1.2  Prior Experience
Calm Health App. Table 1 summarizes five non-Yale clinical trials of the Calm app. 
Participants used the app on an on-demand schedule averaging 38–105 minutes per week across 
studies. Four RCTs and one pilot trial demonstrated favorable effects on mental health 
symptoms, with high satisfaction ratings (81–93% satisfied) and willingness to recommend (76–
79%). Unintended responses were reported with 0% prevalence in the two studies that evaluated 
them.
Table 1. Randomized controlled trials of Calm Health
Trial
Population
Intervention
Control
Outcomes
Treatment 
Evaluation
Unintended 
Effects
NCT03891810 
Ref: 12
College students, 
mean age 21yr 
(n=41 intervention, 
n=47 control)
Introductory module on 
mindfulness ("7 Days of 
Calm") followed by 
exercises of choice. 
Averaged 38 min/wk. 8 
weeks.
Wait list to 
receive Calm 
after study.
Favorable (perceived 
stress, mindfulness, 
self-compassion). 
Neutral (sleep, 
drinking, physical 
activity, diet). Excluded 
non-completers (17%) 
and non-users (3%).
68% likely to 
use in future. 
76% likely to 
recommend.
0%
NCT04045275 
Refs: 13
Adults with sleep 
disturbance, mean 
age 45yr (n=124 
intervention, 
n=139 control)
Introductory module then 
exercises of choice. 
Averaged 105 min/wk. 8 
weeks.
Wait list to 
receive Calm 
after study.
Favorable (daytime 
fatigue, sleepiness, pre-
sleep arousal, 
depression, anxiety). 
Neutral (sleep quality). 
Intention-to-treat.
Not evaluated.
0%
NCT05120310 
Ref: 14
Employees of 
large retailer, 
mean age not 
reported (n=585 
intervention, 
n=444 control)
Self-select exercises. 
Averaged 102 min/wk. 8 
weeks.
Wait list to 
receive Calm 
after study.
Favorable (depression, 
anxiety, insomnia, 
sleepiness, nonwork 
impairment, medical 
visit frequency). 
Neutral (stress, 
resilience, absenteeism, 
presenteeism). 
Intention-to-treat.
Not evaluated.
Not 
evaluated.
NCT04329533 
Ref: 15
Pregnant women 
or women with 
delayed/cancelled 
gynecology 
surgeries during 
COVID-19, mean 
age 36yr (n=51 
intervention, n=50 
control)
Self-select exercises. 37% 
used 5+/wk, 37% used 3-
4/wk, 26% used ≤2/wk. 
30 days.
Wait list to 
receive Calm 
after study.
Favorable (stress, 
depression, anxiety, 
sleep disturbance). 
Intention-to-treat.
81% satisfied. 
86% said easy 
to use.
0%
NCT04272138 
Ref: 23
Middle-aged 
adults with 
elevated stress, 
mean age 52yr 
Self-select exercises. 33 
completed follow-up; 
averaged 103 min/wk, 
App with 
health/wellbeing 
podcasts but no 
mindfulness. 27 
No statistically 
significant changes 
(pilot not powered to 
detect significance).
93% said 
useful. 79% 
likely to 
recommend. 
0%
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(n=39 intervention, 
n=35 control)
71% used ≥49 min/wk. 4 
weeks.
of 35 completed 
follow-up; 62% 
used ≥49 min/wk.
64% would 
continue.
*Ref 23 = Laird et al. 2022, a pilot feasibility study (not a fully powered RCT).
Calm Health is also being used for clinical trials in preparation or ongoing in Yale Oncology 
(NCT06923501, HIC 2000037763) and Yale Pediatrics (NCT07062887, HIC 2000039191). Dr. 
Ash was an investigator on stakeholder interviews in preparation for the pediatrics trial (HIC 
2000038023)24.
Team experience with related digital interventions. The investigative team has extensive 
experience delivering digital lifestyle interventions for related populations including exercise 
support for middle-aged adults with type 1 diabetes (Yale HIC #2000025992, #2000035846; PI: 
Ash)16 and sleep and alcohol support for young adults with heavy drinking habits (Yale HIC 
#2000021048, #2000030417; Co-I’s: Ash, Griffith)17–20. These past studies included both 
lifestyle support guidance and biometric feedback.
2  Rationale/Significance
2.1  Rationale and Study Significance
Adults with CKD experience numerous psychosocial and behavioral challenges. Depression 
affects approximately 26.5% of adults with CKD globally1, and clinically significant anxiety 
affects up to half of all CKD patients2. These mental health conditions impair treatment 
adherence, reduce quality of life, and increase mortality risk. Despite this burden, barriers to 
mental health care are substantial, including the time demands of CKD management, 
transportation constraints, and limited availability of nephrology-informed mental health 
providers.
Mindfulness meditation interventions have shown efficacy in CKD populations, with evidence 
from pre-dialysis through dialysis stages demonstrating improvements in sympathetic nervous 
system function, perceived stress, sleep quality, and inflammatory biomarkers. However, most 
evidence comes from in-person programs during dialysis sessions, and digital mindfulness 
delivery for CKD has not been tested. There is a critical need for scalable, accessible mental 
health tools for this population.
The main purpose of the present study is to pilot test the Calm Health app among adults with 
CKD to determine what refinements are needed before conducting a fully powered randomized 
controlled trial. If that future trial shows a positive signal, it would support the implementation of 
Calm Health for prevention and treatment of mental health conditions among adults with CKD.
Additionally, the app might drive behavior change more strongly if augmented with a biometric 
dashboard enabling adults with CKD to understand connections among mindfulness practice, 
physiological manifestations of distress (sympathetic overdrive, sleep disturbance), and blood 
pressure patterns. In our prior studies, multimodal biometric feedback was enthusiastically 
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received and mitigated health risk scores19,20. Among people with CKD, while routine care often 
involves home blood pressure monitoring, integration of multiple behavioral and cardiovascular 
biometrics for mental health is in nascent stages.
2.2  Risks
#1. Confidentiality: Due to the collection of private identifiable information, there is a 
possibility of a security breach compromising subject confidentiality. Such breaches are 
extremely uncommon when proper IRB-approved precautions are taken.
#2. Unintended psychological changes during intervention: Among the 5 prior clinical trials 
of Calm (Table 1), unintended responses were reported to occur with 0% prevalence in 4 studies 
(255 participants using Calm) and not evaluated in 1 study. Nonetheless, any psychological 
intervention carries risk of unintended changes. A systematic review of meditation practice 
studies assessed 6,703 total participants for adverse events; the overall weighted prevalence was 
8% (95% CI 5%–12%). By comparison, adverse event prevalence in psychotherapy reviews 
exceeded 30%, and in one trial comparing mindfulness to escitalopram for anxiety disorders, 
adverse events occurred for 79% on medication versus 16% receiving mindfulness21.
The GAD-7 and PHQ-8 will be administered every 4 weeks. The PHQ-8 does not include a 
suicidal ideation question; however, any spontaneous disclosure of suicidal ideation during 
check-in calls triggers an immediate safety assessment and crisis response protocol. Response 
thresholds to GAD-7 and PHQ-8 scores focus on change from baseline rather than absolute 
scores, as chronic illness burden may elevate baseline anxiety and depression. Mild/moderate 
scores (PHQ-8 <15, GAD-7 <15) require no immediate follow-up. Severe scores (PHQ-8 ≥15, 
GAD-7 ≥15) or notable worsening (≥5 point increase from baseline on either scale, or movement 
from the moderate to the severe category) trigger follow-up within 48 hours by a trained study 
investigator. Follow-up actions include: (1) providing resources both verbally and in writing 
(Appendix 3: 211 for local social services; 988 National Suicide and Crisis Lifeline, which has a 
Spanish-speaking option; 741741 Crisis Text Line for text-based support; 911 for emergencies); 
(2) offering clinical referral to a mental health provider (psychologist, psychiatrist, counselor) 
with facilitated warm handoff when possible and provision of institutional resources such as 
Yale mental health services; and (3) noting that the participant is concurrently receiving app-
based suggestions from Calm Health. Participants with active suicidal or homicidal ideation will 
be withdrawn and staff will call 988 and inform their primary provider. Note that uremic 
symptoms, fatigue, and chronic illness burden in CKD may contribute to elevated PHQ-8/GAD-
7 scores; therefore medical events (hospitalizations, significant lab changes, symptom 
exacerbations) that coincide with mental health changes will be documented.
Monthly health coaching calls will include a verbal check-in: “Since your last connection with 
our team, have you noticed any changes in your mood or mental health?” These encounters will 
be documented on an excel database stored on OneDrive. A one-week check-in call will be made 
if the patient has not logged into the Calm App, also documented on OneDrive. The research 
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coordinator will review all completed assessments and app check-ins weekly, with Dr. Ash 
performing a second check on a monthly basis.
To facilitate timely responses, surveys and interviews will be administered during in-person or 
remote study visits while on a live Zoom call with research staff.
#3. Study questionnaires and interviews: Participants may experience some distress when 
discussing factors related to CKD, CKD management, and psychosocial stressors. The 
probability of such responses is uncommon and the typical magnitude is mild.
#4. Wrist Actigraphy: In a small number of participants, wearing an actigraphy watch may 
contribute to skin irritation or allergies (reported in 3% of wearers in a prior clinical trial). We 
minimize risk by providing the watch with a hypoallergenic band, training participants in 
manufacturer guidelines, and referring for skin care if irritation occurs.
There are no potential social, cultural, financial, or legal risks.
2.3  Anticipated Benefits
All participants will receive guidance and support for mindfulness from an evidence-based app. 
It is possible they will continue mindfulness practice after the study. The benefits to science may 
include a better understanding of how to engage adults with CKD in mindfulness and improved 
design of future interventions. There is a need to equip adults with CKD with more accessible 
tools for mental health support.
3  Study Purpose and Objectives
3.1  Purpose
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of 
a digital mindfulness intervention (Calm Health) among adults with chronic kidney disease, and 
to develop user-informed biometric data visualizations to augment the intervention.
3.2  Hypotheses
Objective #1, Hypothesis: Adults with CKD will rate Calm Health to be satisfying (≥4 out of 5 
on surveys), citing accessibility and asynchronous availability as strengths.
Objective #2, Hypothesis: Outcome metrics related to perceived stress, quality of life, well-
being, and mental health will show favorable effects after engaging in the mindfulness-based app 
intervention. These variables will be measured at baseline and at 6-week follow-up.
Objective #3, Expected Outcome: Participants seeing a biometric display of their health data 
will have meaningful and actionable reactions, while offering suggestions to improve the way it 
is presented.
3.3  Objectives
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Primary Objective
Objective #1: Determine whether it is feasible and acceptable to use Calm Health, a mobile app 
guiding mindfulness practice, among adults with CKD.
Secondary Objective(s)
Objective #2: Determine whether using Calm Health has favorable effects upon perceived 
stress, quality of life, well-being, mental health, and blood pressure.
Objective #3: Develop visualizations of biometric data and mindfulness app usage timestamps, 
to help adults with CKD review and understand their health data and refine reports by a user-
centered design.
4 Study Design
This will be a single-group, nonrandomized, unblinded, behavioral clinical trial (Figure 1). 
Adults with CKD will use Calm Health for 6 weeks. They will complete pre-post surveys and 
wear an actigraphy watch. We will capture and measure efficacy signal for psychosocial and 
biometric outcomes. At the 6-week visit they will complete an exit survey and interview to 
assess feasibility and acceptability, as well as provide user-centered design input for a biometric 
coaching dashboard.
Calm Health is classified by the FDA as a “general wellness item” (i.e., a product intended to 
improve general health and wellness), which is not within the FDA’s current scope of oversight. 
It is currently commercially available to the general population including adults with CKD. We 
will not modify it from its usual commercial state. Another Yale IRB protocol is testing Calm 
Health for another population (young adults with type 1 diabetes) as a non-medical device, social 
& behavioral research trial (IRES IRB# 2000039191).
Participants can use the app on an on-demand schedule. We will recommend they use it for an 
average of 45 minutes per week, which is approximately one mindfulness session per day. The 
exposure length will be 6 weeks to test retention after initial novelty. Participants will also have 
complementary app access after the study, until November 30, 2026. Calm Health is not 
currently considered standard of care, so all participants will be using it for research purposes. 
Health coaching check-ins will be conducted at Week 1 (troubleshooting for non-users) and 
Week 4 (motivational interviewing session to trial human-delivered coaching in concert with the 
app) by an Allied Health Professional (clinical psychologist, exercise physiologist, dietician, or 
certified health coach).
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Figure 1. Study design. An unscheduled visit 9 may occur for adverse event follow-up. *Event markers capture self-directed 
mindfulness not involving the app, as well as sleep onset/wake. 

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Planned Protocol Modification Informed by Stakeholder Input. A concurrent IRB-exempt 
formative study (Yale HIC #2000042303) will interview at least 3-5 adults with CKD as 
stakeholder input on the study design. The Calm Health app intervention is fixed and will not be 
modified, as it is controlled by the manufacturer. However, elements of the study procedures that 
are delivered by the research team—particularly the health coaching check-in content, format, 
and frequency, as well as survey burden—may be refined based on stakeholder feedback. Any 
such modifications will be submitted as a protocol amendment for IRB approval before 
implementation. Participants enrolled prior to the amendment will continue under the original 
protocol unless the amendment is deemed applicable and beneficial, in which case they will be 
notified.
4.1 Study Duration
Individual participant duration: recruitment to baseline visit will take 1–30 days, and baseline 
visit to end of follow-up will take 6 weeks, for a total duration of approximately 2.5 months. The 
cutoff date for enrollment will be October 15, 2026 so that each participant can complete the 6 
weeks of app access before the accounts expire on November 30, 2026. The period from 
December 2026 – March 2027 has been allocated for data analysis and dissemination. Total 
study duration: 1 year (April 15, 2026 – March 31, 2027).
4.2 Outcome Variables/Endpoints
4.2.1 Primary Outcome Variables/Endpoints
Objective #1
Metrics of Feasibility. Minutes per week of mindfulness app use, including mindfulness 
exercises, sleep mindfulness exercises, and other general content (music, daily wisdom, etc.) will 
be recorded using the Calm Health app backend dashboard.
Metrics of Acceptability. Quantitative methods: Participants will complete an exit survey 
including implementation outcome measures (acceptability, appropriateness, feasibility; α=.85–
.91), net promoter score, and Likert-style satisfaction items. Qualitative methods: Semi-
structured interviews will elicit perspectives about acceptability of the app, how app use affected 
attitudes toward CKD management, barriers and facilitators to using the app (including cultural 
influences), and overall satisfaction.
4.2.2  Secondary and Exploratory Outcome Variables/Endpoints
Objective #2
Table 2. Efficacy outcome assessments
Psychometric 
Assessment
Role in Study
Description
No. 
Items
Time
Timing
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Five Facet 
Mindfulness 
Questionnaire 
(FFMQ)
Verification of 
intervention 
delivery
Validated self-report 
measuring 5 domains: 
observing, describing, 
acting with awareness, 
nonjudging, nonreacting.
39
10–15 
min
Baseline & 6-
wk follow-up
Self-Compassion 
Scale (SCS)
Mechanism 
targeted by 
intervention
Validated measure of 
self-kindness, self-
judgment, common 
humanity, isolation, 
mindfulness, and over-
identification.
26
7 min
Baseline & 6-
wk follow-up
Chronic Disease 
Self-Efficacy 
Scale from 
Stanford (CDSES) 
Mechanism 
targeted by 
intervention
Validated self-report 
assessing confidence in 
managing chronic illness 
across domains.
33
10 
min
Baseline & 6-
wk follow-up
Brief Resilience 
Scale (BRS)
Mechanism 
targeted by 
intervention
Validated 6-item measure 
of ability to bounce back 
from stress.
6
2 min
Baseline & 6-
wk follow-up
Perceived Stress 
Scale (PSS-10)
Mental health 
mechanism 
reachable by 
intervention
Validated 10-item 
measure of perceived 
stress over the past 
month; widely used in 
CKD research.
10
5 min
Baseline & 6-
wk follow-up
Kidney Disease 
Quality of Life 
(KDQOL-36)
Downstream life 
impact
CKD-specific quality of 
life measure including 
burden of kidney disease, 
symptoms/problems, and 
effects of kidney disease 
subscales, plus SF-12.
36
10 
min
Baseline & 6-
wk follow-up
Short Warwick-
Edinburgh Mental 
Well-Being Scale 
(SWEMWBS)
Downstream life 
impact
Validated 7-item measure 
of positive mental well-
being.
7
2 min
Baseline & 6-
wk follow-up
Generalized 
Anxiety Disorder 
7 (GAD-7)
Calm Health 
App Calibration
Validated screener for 
anxiety.
7
5 min
Baseline & 4-
wk follow-up
Patient Health 
Questionnaire 8 
(PHQ-8)
Calm Health 
App Calibration
Validated 8-item screener 
for depression (does not 
include suicidal ideation 
question).
8
5 min
Baseline & 4-
wk follow-up
Objective #3: Participants will review a biometric report over televideo screenshare and 
complete cognitive interviewing (think aloud) during the presentation, followed by questions 
about perceptions of their health data, strengths and limitations of the format, and proposed 
refinements.
The biometric report is a personalized, multi-modal visualization of data collected during all 
weeks of the 6-week intervention period. It will display participant-level trends across: (1) Calm 
Health app usage, including session timestamps and cumulative minutes; and (2) actigraphy-
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derived metrics including physical activity, sleep duration, heart rate, heart rate variability, blood 
pressure, respiratory rate, and skin temperature. Data streams will be aligned on a common 
timeline to allow participants to observe potential relationships between mindfulness practice 
patterns and physiological indicators (Appendix 7a). Actigraph data are not for clinical use and 
will not be reviewed by a physician. 
The report will be presented to participants via televideo screenshare at Visit 8, during which 
they will complete a cognitive interviewing (think-aloud) protocol followed by structured 
questions about data comprehension, report format, and proposed refinements (see Appendix 7b: 
Cognitive Interview Guide).
The Actigraph Leap 2 watch does not directly measure blood pressure or display blood pressure 
readings. It collects a photoplethysmography (PPG) signal - the same physiological input used by 
dedicated blood pressure wearables - but delivers the raw waveform data rather than a pre-
processed blood pressure value. The study team will process this raw PPG signal into blood 
pressure estimates using the algorithm described by Radha et al.26, which applies heart rate 
variability and pulse morphology features extracted from wrist PPG to a Long Short-Term 
Memory (LSTM) neural network to estimate within-person blood pressure trends. This approach 
is validated for free-living ambulatory use and is appropriate for the study's goal of tracking 
relative patterns (e.g., higher versus lower BP periods) rather than absolute clinical-grade 
readings. Participants will be informed that these estimates are not for clinical use. This data 
workup will be completed by the study team prior to Visit 8 so that blood pressure trend data are 
available in the participant's personalized biometric report at that visit.
5  Study Participants
5.1  Study Population
Participants aged 18 years and older diagnosed with CKD for at least 6 months with at least two 
consecutive nephrology visits within a 1 year window, the last occurring within the past year. 
They will be patients of Yale Medicine Nephrology or Yale New Haven Hospital. These 
institutions serve a diverse sample of adults with CKD. This population was selected because 
they face many barriers to accessing healthcare for the mental health sequelae of CKD, and could 
benefit from a mobile mindfulness solution.
5.2  Number of Participants
We will enroll 26 participants. We may need to screen up to 52 participants.
5.3  Eligibility Criteria
In order to be eligible for inclusion in the study, an individual must meet all of the following 
criteria:
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1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration 
of the study.
3. Aged 18-80 years inclusive.
4. Diagnosed with CKD for at least 6 months with at least two consecutive nephrology 
visits within a 1 year window, the last occurring within the past year.
5. Receiving CKD care at Yale Medicine Nephrology or Yale New Haven Hospital.
6. Able to use a smartphone. The study team will provide a smartphone if the individual 
does not own one.
7. Able to read and write English.
Any individual who meets any of the following criteria will be excluded from participation in 
this study:
1. Current meditation or mindfulness practice meeting or exceeding the a typical 
recommended schedule (70 minutes per week)25 over the past 1 month.
2. New or unstable psychopharmaceutical treatment in past 2 months. Note: Stable 
maintenance therapy (no dose/medication changes for ≥8 weeks) is acceptable.
3. Current intensive psychiatric treatment (psychiatric hospitalization in past 6 months, 
intensive outpatient program, inpatient rehabilitation).
4. Current or planned pregnancy in the next 6 months, based on self-report and confirmed 
by medical record review.
5. 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.
5.4 Recruitment Procedures
Clinic attendings will identify study candidates from the daily clinic schedules. They or research 
staff will contact these patients by phone, text message, email, mail, MyChart message, or in-
person at regular clinic visits. Calls and text messages will be sent during hours of 10am–8pm. 
The HRPP’s guidance on recruitment of patients will be followed. If the potential participant was 
not first identified during a clinic visit, their primary nephrology provider will make the initial 
contact and obtain their verbal permission for non-clinical research team members to make 
contact.
The study will also be publicly announced via research flyers at Yale Medicine Nephrology and 
Yale-New Haven Hospital. The study will be posted on clinicaltrials.gov and the YCCI website. 
In the event of recruitment shortfall, we may elect to amplify these postings through social media 
and 3rd-party sites such as ResearchMatch. 
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Interested individuals will be invited to inquire about the study by contacting investigators by 
telephone or email, or by providing eligibility information on a secure HIPAA-compliant 
Qualtrics webform (Appendix 8). Participants passing both the first and second tiers of the 
eligibility interview (Appendix 8) will be invited to schedule a consenting televideo visit on 
Zoom. 
5.5  Consent/Assent Procedures/HIPAA Authorization
•
Consent will use the standard IRB-approved compound consent / HIPAA research 
authorization form.
•
A PDF of each IRB-approved form will be converted to an electronic survey on YCCI’s 
approved REDCap e-consent framework, which includes a final certification screen, PDF 
storage, and fields for wet signatures.
•
The forms describe in detail the study intervention, study procedures, and risks. Written 
electronic documentation of informed consent is required prior to starting study 
assessments.
•
A principal investigator, co-investigator, or research assistant will explain the research 
study to the participant and answer any questions. This conversation will take place over 
a Zoom televideo call from as private a physical setting as possible.
•
Participants will have the opportunity to carefully review the electronic written forms and 
ask questions prior to signing. A quiz will be used to ensure understanding (Appendix 
14). Participants may discuss the study with family before agreeing.
•
Participants must be informed that participation is voluntary and that they may withdraw 
at any time, without prejudice. A PDF of the signed consent document will be sent by 
encrypted email.
This study does not involve children. Assent will not be obtained.
6  Study Methods/Procedures
6.1  Study Procedures
Table 3. Visit Schedule
Procedure
Pre-
scree
n
Consen
t
Enroll
Wkly 
Chec
k-In
Health 
Coaching 
and 
Recalibrat
ion 
Wkly 
Check-
In
Follow-
Up
Unscheduled
Visit 
Number
0
1
2
3-5
6
7
8
9
Week 
Number
-2
-1
0
1-3
4
5
6
N/A
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Screening 
Phone Call
X
Informed 
Consent
X
Demographic
s
X
Clinical 
history
X
X
X
REDCap 
surveys 
(FFMQ, 
CDSES, 
CDSES, 
BRS, PSS, 
KDQOL, 
SWEMWBS; 
Table 2)
X
X
Actigraph 
watch
Continuous → → →→→→→→→→→→→→→→→
Train to use 
Calm Health 
app
X
Calm Health 
in-app 
calibration 
surveys 
(GAD-7, 
PHQ-8; 
Table 2)
X
X
Use Calm 
Health App
Continuous → → →→→→→→→→→→→→→→→
Check-in: 
app usage, 
barriers, 
other 
mindfulness, 
other digital 
interventions, 
mental health 
services, 
X
X
X
X
Health 
coaching 
X 
(visit 
3, 
only 
if not 
using 
Calm 
Healt
h)
X
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Exit survey 
& interview
X
Biometric 
report 
interview
X
Adverse 
events check-
in
X
X
X
X
X
Time of 
procedures 
(min)
15
60
90
15
15
15
90
60
*Depicted in this chart are extra readings taken for study purposes. Participants will also take all readings ordered 
by their physician as standard of care. 
All procedures in this chart are taken for research purposes. Total research procedure time is 
approximately 5 hours. In addition, participants are asked to use the app 45 minutes per week for 
6 weeks, for an expected total time commitment of approximately 10 hours.
Health Coaching Check-Ins. In addition to the monitoring schedule above, two structured 
health coaching check-ins will be conducted by an Allied Health Professional (clinical 
psychologist, exercise physiologist, dietician, or certified health coach). At Week 1, participants 
who have not logged into the app will receive a coaching call to troubleshoot barriers to 
engagement. These barriers may be technical (app navigation, device compatibility) or logistical 
(adjusting daily routine to make time for using the app). At Week 4, a health coaching session 
will trial approaches for how human-delivered coaching can work in concert with the app-based 
intervention. This session will use a motivational interviewing approach, with fidelity assessed 
using the Motivational Interviewing Treatment Integrity (MITI) evaluation framework 
(motivationalinterviewing.org). The Week 4 coaching session will explore the participant’s 
experience with the app, reinforce intrinsic motivation for mindfulness practice, and 
collaboratively problem-solve any ongoing barriers. The health coaching curriculum (Appendix 
13c) may undergo refinement based on stakeholder interviews that are occurring on a separate 
protocol currently in review for IRB exemption (HIC #2000042303), upon which a modification 
to the current trial would be submitted. 
6.1.1  Data Collection
Survey data will be collected via REDCap (Visits 1, 2, 8) and Qualtrics SMS surveys (Visits 3–
7). Calm Health usage data and responses to the calibration surveys (GAD-7, PHQ-8) will be 
captured through the app backend dashboard. Actigraph watch will be shipped back in a prepaid 
package and data will be downloaded from the device before Visit 8. Participants will not be 
penalized for lost Actigraph watches since they do not have resale value. Interviews will be 
audio-recorded on Zoom – for participants who consent to recording - and transcribed. See 
Section 8 (Table 4) for full data collection workflows. 
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Medical Chart Review. At enrollment and follow-up visits, research staff will review the 
participant’s medical chart (Epic) to capture: demographics and vital signs such as height and 
weight; diagnoses and medications; metabolic panel; cystatin C). Chart review data will be 
compared against participant self-report and used to characterize the clinical profile of the 
sample.
Actigraph Event Markers. The Actigraph Leap 2 watch includes an event marker button. 
Participants will be trained to press the event marker button at two times: (1) when they begin 
and end a mindfulness practice that is not guided by the Calm Health app (e.g., informal 
mindfulness during a walk), and (2) at sleep onset and wake time, to supplement the actigraphy 
sleep algorithms which can sometimes misidentify sleep start and stop times.
Weekly Surveys. On a weekly basis (Visits 3–7), participants will complete a brief SMS survey 
covering: facilitators and barriers to engaging with Calm Health; barriers or challenges to study 
participation more broadly; windows of Actigraph removal (if any); mental health services 
utilization (e.g., therapy appointments, psychiatric visits, crisis contacts); other digital health 
interventions used (devices and modules outside the study); other mindfulness practices outside 
of Calm Health; and any clinical events or adverse events. Research staff will follow up on any 
reported barriers or adverse events by telephone.
Biometric Report Preparation and Delivery. Prior to Visit 8, research staff will compile a 
personalized biometric report integrating data collected across the 6-week intervention period. 
The report will display participant-level trends across: Calm Health app usage, including session 
timestamps and cumulative minutes; self-directed mindfulness practice captured via Actigraph 
event marker presses; and actigraphy-derived metrics including physical activity, sleep duration, 
heart rate, heart rate variability, blood pressure, and skin temperature. Data streams will be 
aligned on a common timeline to allow participants to observe potential relationships between 
mindfulness practice patterns and physiological indicators. The report will be presented to 
participants via televideo screenshare during Visit 8 (see Appendix 7a for a sample report).
Cognitive Interview. The biometric report will be presented using a think-aloud cognitive 
interviewing protocol (Appendix 7b), in which participants verbalize their thoughts and reactions 
in real time as they view each section of the report. This procedure is distinct from the exit 
interview (Appendix 2), which addresses overall app acceptability and experience; the cognitive 
interview focuses specifically on participants' comprehension of and reactions to their health data 
as presented in the biometric report. Following the think-aloud portion, structured questions will 
address perceived strengths and limitations of the report format and proposed refinements. 
Responses will inform iterative, user-centered development of the biometric report for future 
trials. The session will be audio-recorded on Zoom and transcribed per the procedures described 
in Table 4.
6.2  Method of Assignment/Randomization
Not applicable. This is a single-arm study with no randomization.
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6.3  Adverse Events Definition and Reporting
An adverse event is any untoward medical occurrence associated with the use of an intervention 
in humans, whether or not considered intervention-related. An adverse event or suspected 
adverse reaction is considered serious if, in the view of either the investigator or study physician, 
it results in any of the following outcomes: death; a life-threatening adverse event; inpatient 
hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity 
or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly 
or birth defect.
Adverse event monitoring will follow a structured schedule. The GAD-7 and PHQ-8 will be 
administered every 4 weeks. Results will be stored on the Calm Health portal and exported 
weekly by the program coordinator. The research coordinator will conduct weekly data reviews 
of all completed assessments and app check-ins. Monthly check-in calls will include a verbal 
check-in asking whether participants have noticed changes in mood or mental health; these 
encounters will be documented on an excel database stored on OneDrive. A one-week check-in 
call will be made only if the patient has not logged into the Calm App, also documented on 
OneDrive. Dr. Ash will perform a second check on a monthly basis. Adverse event information 
will also be recorded from the medical record at the unscheduled follow-up visit.
An adverse event report will be generated for each event including: description of the event; 
when and how it was reported; official chart records; and principal investigator assessment of 
likelihood of being related to the study (not, unlikely, possibly, probably, definitely), severity 
(mild, moderate, severe), whether the severity was anticipated, and whether the frequency was 
anticipated.
Timeline for reporting: Events that may require interruption of study activities will be verbally 
reported immediately with a written report within 5 business days. Reportable Events (serious or 
life-threatening, unanticipated, and possibly related) will be filed within 5 business days. 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) will be filed within 5 
business days with a management plan.
6.4  Reaction Management
Response thresholds focus on change from baseline rather than absolute scores, as chronic illness 
burden (uremic symptoms, fatigue) may elevate baseline anxiety and depression in CKD. 
Medical events that coincide with mental health changes (hospitalizations, significant lab 
changes, symptom exacerbations) will be documented. Suicidality Monitoring: The PHQ-8 does 
not include a suicidal ideation question. Any spontaneous disclosure of suicidal ideation during 
check-in calls triggers an immediate safety assessment and crisis response protocol. Score 
Interpretation: Mild/Moderate scores (PHQ-8 <15, GAD-7 <15) require no immediate follow-up. 
Severe scores (PHQ-8 ≥15, GAD-7 ≥15) or notable worsening (defined as ≥5 point increase from 
baseline on either scale, or movement from the moderate to the severe category) trigger follow-
up actions within 48 hours by a trained study investigator. Follow-up actions for severe or 
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worsening scores include: (1) Initiate follow-up within 48 hours by a trained study investigator. 
(2) Provide resources both verbally and in writing: 211 for local social services; 988 National 
Suicide and Crisis Lifeline (988lifeline.org, has Spanish-speaking option via press 2); 741741 
Crisis Text Line (complements 988 by providing text option; text HOME for English or AYUDA 
for Spanish); 911 for emergency services. Document that resources were provided. (3) Offer 
clinical referral by connecting the participant to a mental health provider (psychologist, 
psychiatrist, counselor), facilitating a warm handoff when possible, and providing institutional 
resources (e.g., Yale mental health services). (4) Note that concurrently, the user is getting 
suggestions from the Calm Health app. Participants with active suicidal or homicidal ideation 
will be withdrawn and staff will call 988 and inform their primary provider.
6.5  Withdrawal Procedures
Participants may withdraw voluntarily at any time for any reason. Participants having active 
suicidal or homicidal ideation will be withdrawn early from the study. Participants withdrawing 
early due to lack of interest in mindfulness exercises will be invited to still complete the 6-week 
follow-up assessments (visit 8), but will stop receiving weekly check-in surveys.
6.6  Locations/Facilities
1 site for data collection: Yale School of Medicine, New Haven, CT.
2 sites for recruitment: Yale New Haven Hospital, New Haven, CT; Yale Medicine Nephrology, 
Stamford, CT.
7  Statistical Design
7.1  Sample Size Considerations
We will enroll 26 participants, which gives 80% statistical power to detect any feasibility 
problems having ≥6% incidence22. We will submit a modification to enroll additional 
participants if needed to have interviews reach thematic saturation, which typically occurs within 
10–20 participants.
7.2  Planned Analyses
Aim 1 – Quantitative Analysis: Metrics of mindfulness app usage and satisfaction survey 
scores will be summarized by descriptive statistics. We will compare results with a priori 
standards: 1) engagement compared to 45 minutes per week; 2) general satisfaction scores of 4–5 
out of 5.
Aim 1 – Qualitative Analysis: Interviews will be audio-recorded for participants who consent to 
it, transcribed verbatim, and imported into NVivo. Interviewers will also add summaries of 
interviews where participants do not consent to recording. The investigative team will 
collaboratively identify general coding categories from nephrology and implementation science 
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perspectives, followed by identification of subthemes and coding of excerpts using inductive, 
directed qualitative content analysis.
7.2.1  Secondary Objective Analyses
Aim 2: Our focus is calculating pre-post effect sizes for each variable. We will consider data 
distributions and choose an appropriate effect size formula (Hedge’s g for a small but normally 
distributed sample, or biserial r for a non-normally distributed sample). We will use Fritz’s 
formulas to convert to Cohen’s d and evaluate size (d≥0.20 small, ≥0.50 moderate, ≥0.80 large), 
while also considering the raw metric in relation to clinically meaningful change.
Aim 3: Qualitative analysis will employ similar core methods as Aim 1. The outcome will 
identify common themes to guide refinement of personalized biometric reports.
Safety: Safety will be quantified as the frequency of adverse events overall and by type, 
expressed as proportions with 95% confidence intervals. It will be compared numerically to the 
literature finding of 8% adverse events from meditation.
7.2.2  Analysis of Subject Characteristics
Demographics (age, sex, gender, race, ethnicity, household income, education level, public vs. 
private insurance, duration of CKD, CKD stage), descriptive clinical characteristics from chart 
review (eGFR, metabolic panel, lipid panel, glucose measures, diagnoses, medications, height, 
weight), and derived indices (body mass index) will be tabulated. Categorical variables will be 
reported as proportions; continuous variables will be reported as mean±standard deviation if 
normally distributed or median (25th, 75th percentile) if non-normally distributed.
7.2.3  Interim Analysis
The sole stopping rule will be clear evidence of harm. There is no possibility of futility of 
treatment or overwhelming evidence of benefit, as this study evaluates feasibility and 
psychological mechanisms. No interim analyses are planned.
7.3  Data Relevance
All data collected are directly relevant to the study objectives. The survey instruments were 
selected to capture mechanisms targeted by mindfulness (self-compassion, self-efficacy, 
resilience), mental health outcomes reachable by the intervention (perceived stress, anxiety, 
depression), and downstream quality of life and well-being impacts specific to CKD (KDQOL-
36, MWBS).
7.4  Data Coding
Quantitative data will be coded by anonymous study ID number. Qualitative interview data will 
be de-identified during transcription and coded using NVivo.
7.5  Data Analysis Tools
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Quantitative analyses will be performed using R or Stata. Qualitative analyses will use NVivo. 
Biometric data processing will use ActiLife software (Actigraph) and manufacturer dashboards.
7.6  Data Monitoring
Calm Health usage will be monitored weekly through the backend dashboard. 
Weekly SMS surveys will be monitored through Qualtrics. 
Actigraph data will be audited at device download for completeness. Actigraph data are not for 
clinical use. 
Dr. Ash will perform data audits after the first month and at least twice per year.
7.7  Handling of Missing Data
We will run an intention-to-treat analysis with last observation carried forward and a per-
protocol (completers only) analysis. To avoid missing data, we will make efforts to contact 
individuals who stop using the app to nonetheless complete the 6-week assessment, though they 
will not receive the weekly surveys since those mostly pertain to app usage and barriers.
We will analyze both the full sample and individuals completing the recommended dose of 45 
minutes per week. We acknowledge possible confounders (life events, changes in lifestyle 
habits) and moderator variables (gender, race, ethnicity, education level), but this pilot study is 
not powered for these analyses.
8  Data/Specimen Handling and Record Keeping
Table 4 details the data sources, timing, HIPAA identifiers, collection workflows, and protocols 
for exporting and deidentifying data during the study. Data can be accessed by members of the 
research team. The master key of participant IDs will be destroyed 1 year after the completion of 
data collection, thus kept for a total of 2 years for the earliest participants and 1 year for the latest 
participants. De-identified data will be stored indefinitely.
Table 4. Data sources and collection workflows
Data Source
Timing
HIPAA Identifiers
Data Collection Workflow
Data Export to Yale Server and 
Deidentification
Actigraph Leap 2 
Watch
Visit 2 through 
Visit 8
None
Researchers connect watch by 
physical cord to computer with 
ActiLife software.
Researchers export from ActiLife 
Software.
Calm Health
Visit 2 through 
Visit 9
IP address and phone 
number used by 
manufacturer to 
deliver content, not 
shared with research 
team. Participant is 
asked to enter DOB 
to help app make 
content 
recommendations. 
Participant has 
Researchers view backend 
dashboard displaying usage from 
user accounts (does not display 
location) which are identified by 
anonymous email address created by 
research team.
Researchers export from backend 
dashboard, remove names, and align 
anonymous email address with study ID 
number.
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option to enter first 
and/or last name so 
app can personalize 
greetings.†
Yale REDCap
Visits 1, 2, 8
Identifying 
information on 
contact details form. 
Separate from other 
data.
Researchers and participants enter 
information into survey forms and 
source documents.
Researchers export data except identifying 
information.
Yale Qualtrics
Visits 3–7
Participant phone 
number entered to 
transmit SMS 
survey. Separate 
from other data.
Participants enter information into 
survey forms.
Researchers export data except identifying 
information.
Yale Zoom 
recordings of 
interviews
Visit 8
Voice, names, 
places, others that 
participants may 
mention.
Zoom saves recording and transcript 
on its Yale cloud.
Researchers download from cloud, remove 
identifying information (names, places, 
other) from transcript, and check transcript 
for accuracy against recording. Recording 
will then be promptly destroyed.
Yale clinic 
medical charts
Visits 1, 8, 9
Medical records 
include patient 
identifiers required 
by Yale health 
system.
Researchers view records to verify 
information reported by participant 
during study visits.
Corrections to participant reports are 
manually logged by researchers in 
REDCap. No data are directly exported.
†Calm Health has completed a security planning assessment with Yale ITS for the handling of high-risk data. Documentation is attached.
8.1  Subject Data Confidentiality
Participant confidentiality and privacy is strictly held in confidence by the participating 
investigators, their staff, and the sponsor(s)/funding agency. All research activities will be 
conducted in as private a setting as possible. Representatives of the IRB, regulatory agencies, or 
study funding agencies may inspect all documents required to be maintained by the investigator.
Study participant research data will be transmitted to and stored at Yale University servers. 
Individual participants will be identified by a unique study identification number (MK01, MK02, 
etc., assigned in order of consenting). The study data entry and management systems will be 
secured and password protected. A master list linking study number to participants is only 
accessible to authorized study personnel via REDCap report view.
8.2  Data Quality Assurance
Staff will attend training sessions with Dr. Ash on database monitoring. Actigraph data will be 
audited at device download. Calm Health usage will be monitored weekly. Audio-recorded 
interviews – for participants consenting to audio recording - will be checked for accuracy before 
recordings are destroyed. REDCap survey and source documents will be checked after each visit. 
Dr. Ash will perform data audits after the first month and at least twice per year. Health coaching 
fidelity will be assessed through periodic peer review by Dr. Ash or another qualified health 
coach (Appendix 13a) and coach self-reflection (Appendix 13b) at least once during the study, 
with additional reviews conducted if quality concerns are identified.
8.3  Data or Specimen Storage/Security
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REDCap and Yale OneDrive are password-protected with authorized access only. All research 
team members will complete standard IRB trainings before protocol access. All data are coded 
by anonymous study ID number linked in one section of REDCap to identifiers. Calm Health has 
completed a security planning assessment with Yale ITS for the handling of high-risk data; 
documentation is attached.
8.4  Study Records
Study records will be maintained by Dr. Ash on Yale OneDrive. These include IRB documents 
on Yale OneDrive and IRES, an internal standard operating procedure manual, adverse event 
forms, and confidential data sources. E-Consent forms are stored on REDCap.
8.5  Access to Source
Source documents include exports from Yale clinic dashboards, Actigraph ActiLife software, 
Calm Health, REDCap, and Qualtrics. They will be aligned into a master database with person-
level demographics, health outcomes, and continuous biometrics (blood pressure, physical 
activity, sleep, heart rate, heart rate variability, skin temperature).
8.6  Retention of Records
The code key linking participant identifying information to data will be destroyed 1 year after the 
end of the study. De-identified data will be kept indefinitely. Participant contact information will 
be retained if they express interest in future studies, until they ask to no longer be contacted.
8.7  Data and Safety Monitoring Plan
As the contact Principal Investigator, Dr. Ash will monitor the data, assure protocol compliance, 
and conduct safety reviews at least annually. He will evaluate whether the study should continue 
unchanged, require modifications, or close to enrollment.
Dr. Ash will promptly report any Reportable Events and Unanticipated Problems Involving 
Risks to Subjects or Others to the IRB and any appropriate funding and regulatory agencies 
within 5 business days. He will apprise fellow investigators of all UPIRSOs and adverse events 
and submit annual renewal progress reports per IRB standard procedures.
Dr. Ash will immediately report any Unanticipated Problems Involving Risks to Subjects or 
Others that may require a temporary or permanent interruption of study activities (if possible), 
followed by a written report within 5 business days of Dr. Ash becoming aware of the event to 
the IRB and any appropriate funding and regulatory agencies. 
Dr. Ash will apprise fellow investigators and study personnel of all UPIRSOs and adverse events 
that occur during the conduct of this research project. 
Dr. Ash’s assessment is that the study activities pose minimal risk. The risks stated in section 2.2 
are either standard research risks (confidentiality, adverse response to questionnaires), inherent 
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to mindfulness which is a widely recommended wellness practice, or tantamount to wearing 
commercially available fitness watches.
9  Study Considerations
9.1  Institutional Review Board (IRB) Review
The protocol will be submitted to the IRB for review and approval. Approval must be obtained 
before initiating any research activity. Any change to the protocol will require an approved IRB 
amendment before implementation. The IRB will have final determination whether informed 
consent and HIPAA authorization are required. Study closure will be submitted to the IRB after 
all research activities have been completed. Other study events (e.g., data breaches, protocol 
deviations) will be submitted per Yale policies.
9.2  Research Personnel Training
All research team members will complete standard IRB trainings in protection of human subjects 
before being added to the protocol. Staff will attend training sessions with Dr. Ash on study 
procedures, database monitoring, and adverse event detection and management.
9.3  Study Monitoring
Safety monitoring will be handled by the contact PI and study physician according to the 
protocol specified in Section 8.7. Data quality monitoring will be handled by the contact PI 
according to Section 8.2.
9.4  Unanticipated Problems and Protocol Deviations
Unanticipated problems involving risks to participants or others include, in general, any incident, 
experience, or outcome that meets all of the following criteria: (1) unexpected in terms of nature, 
severity, or frequency given the research procedures described in the IRB-approved protocol and 
informed consent document, and the characteristics of the participant population being studied; 
(2) related or possibly related to participation in the research, where "possibly related" means 
there is a reasonable possibility that the incident, experience, or outcome may have been caused 
by the procedures involved in the research; and (3) suggests that the research places participants 
or others at a greater risk of harm — including physical, psychological, economic, or social harm 
— than was previously known or recognized.
A protocol deviation is any noncompliance with the protocol. Corrective actions are to be 
developed and implemented promptly. Deviations will be detected through data audits and 
source document checklists. The principal investigators will review deviations to determine 
whether they involve risks to participants and/or are likely to recur.
Unanticipated problems involving risks to participants or others will be reported to the IRB 
within 5 business days of the investigator becoming aware of the event. Reports will include: 
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protocol identifying information; a detailed description of the event; the basis for determining it 
represents an unanticipated problem; and corrective actions taken or proposed. Protocol 
deviations that do not meet the threshold for an unanticipated problem will be reported to the 
IRB per Yale IRB policies and will be documented in study source documents. All deviations - 
whether or not they constitute unanticipated problems - will be reviewed by the principal 
investigators to determine whether they involve risks to participants and whether they are likely 
to recur, and corrective actions will be implemented promptly.
9.5  Study Discontinuation
Either principal investigator, the study physician, or the Yale IRB has authority to discontinue 
the study as a corrective action to UPIRSOs defined in Section 6.3.
9.6  Study Completion
Estimated study completion: March 31, 2027. The IRB will be notified by submission of a 
closure.
9.7  Conflict of Interest Management Plan
The independence of this study from any actual or perceived influence is critical, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed 
and managed. Furthermore, persons who have a perceived conflict of interest will be required to 
have such conflicts managed in a way that is appropriate to their participation in the trial. The 
study leadership in conjunction with the appropriate conflict of interest review committee has 
established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of interest.
All investigators will follow applicable conflict of interest policies. Any actual or perceived 
conflict of interest will be disclosed and managed.
Calm Health has formed a professional services agreement with Yale University to provide app 
access, backend dashboard access, and configure the app according to the study protocol. They 
will have no involvement with any aspect of the research including conduct, analysis, or 
publication. 
Co-Investigator Dr. Griffith is an unpaid consultant for Calm Health and clinical author of their 
CKD module of mindfulness exercises that is under construction. Dr. Frances Griffith will not 
determine subject eligibility, be involved in the consent process, or perform analysis of 
identifiable or non-identifiable data. 
Dr. Garrett Ash, principal investigator for this study, is a scientific advisor to Behavioral Health 
Tech Innovations LLC and has a provisional patent filed for a digital system for lifestyle 
medicine (047162–5346-P1US). A management plan for these conflicts is in place with Yale 
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University and generally involves Dr. Ash’s recusal from purchasing decisions involving these 
entities. Behavioral Health Tech Innovations LLC is unrelated to this study and not involved in 
this research. Dr. Garrett Ash has no direct conflict of interest with Calm Health that requires 
management.
9.8  Funding Source
Gift funds in the Section of Nephrology (Hollis Family).
9.9  Publication Plan
The principal investigators are responsible for presenting and publishing the study results. We 
plan to present results at the American Society of Nephrology Scientific Sessions or the Society 
of Behavioral Medicine, and intramurally at Nephrology and General Internal Medicine 
Research in Progress meetings. We plan to publish at least 1 manuscript in journals such as the 
Journal of Medical Internet Research or the Journal of the American Society of Nephrology.
10  Appendices
Appendix 
#
Title
Section
Topic
1
Exit (treatment evaluation) Survey
4.2.1 Primary Outcomes
Treatment Evaluation
2
Exit (treatment evaluation) Interview
4.2.1 Primary Outcomes
Treatment Evaluation
3
Crisis Resources
2.2 Primary Outcomes
Adverse Reaction Management
4
FFMQ, SCS, CDSES, BRS, PSS-10
4.2.2 Secondary 
Outcomes
Efficacy outcome measures
5
KDQOL-36, SWEMWBS
4.2.2 Secondary 
Outcomes
Efficacy outcome measures
6
Generalized Anxiety Disorder (GAD-
7) Scale, Patient Health 
Questionnaire (PHQ-8) Scale
4.2.2 Secondary 
Outcomes
Efficacy + safety monitoring
7a
Biometric Report Sample
4.2.2 Secondary 
Outcomes
User-centered design
7b
Cognitive Interview Guide
4.2.2 Secondary 
Outcomes
User-centered design
8
Eligibility Interview
5.4 Recruitment
Recruitment & Screening
9
Advertisements
5.4 Recruitment
Recruitment
10
Research Intake Source Document
6.1 Study Procedures
Source Document
11
Calm Health User Experience
6.1 Study Procedures
Mobile App Information
12
Weekly Check-In Survey
6.1 Study Procedures
Source Document
13a
Health Coaching Fidelity Review 
Form
8.2 Data Quality 
Assurance
Quality Monitoring
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13b
Health Coach Self-Reflection Form
8.2 Data Quality 
Assurance
Quality Monitoring
13c
Health Coaching Curriculum
6.1 Study Procedures
Staff Materials
14
Consent Quiz
5.5 Consent & 
Authorization 
Procedures
Consent Materials
11  List of Tables
Table 1. Randomized controlled trials of Calm Health (see Section 1.2)
Table 2. Efficacy outcome assessments (see Section 4.2.2)
Table 3. Visit schedule (see Section 6.1)
Table 4. Data sources and collection workflows (see Section 8)
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References
1. Adejumo OA, Akinbodewa AA, Iyawe IO, et al. Global prevalence of depression in chronic kidney disease: a 
systematic review and meta-analysis. J Nephrol. 2024;37:2455-2472.
2. Cogley C, Bramham J, Bramham K, et al. High rates of psychological distress, mental health diagnoses and 
suicide attempts in people with chronic kidney disease in Ireland. Nephrol Dial Transplant. 2023;38(10):2152-2159.
3. Shafi ST, Shafi T. A comparison of anxiety and depression between pre-dialysis chronic kidney disease patients 
and hemodialysis patients using Hospital Anxiety and Depression Scale. Pak J Med Sci. 2017;33(4):876-880.
4. Chu SW, Yeam CT, Low LL, et al. The role of mind-body interventions in pre-dialysis chronic kidney disease 
and dialysis patients—A systematic review. Complement Ther Med. 2021;57:102652.
5. Razzera BN, Adamoli AN, Ranheiri MF, et al. Impacts of mindfulness-based interventions in people undergoing 
hemodialysis: a systematic review. Braz J Nephrol. 2021;44(1):84-96.
6. Yang H, Qi L, Pei D. Effect of psychosocial interventions for depression in adults with chronic kidney disease: a 
systematic review and meta-analysis. BMC Nephrol. 2024;25(1):17.
7. Nadort E, Schouten RW, Witte SH, et al. Treatment of current depressive symptoms in dialysis patients: a 
systematic review and meta-analysis. Gen Hosp Psychiatry. 2020;67:26-34.
8. Zahra Z, Effendy E, Mawarpury M, Jaya I. Psychotherapies for chronic kidney disease patients with 
hemodialysis: a systematic review. Narra J. 2023;3(3):e215.
9. Schmill P, Seaton N, Greenwood S, et al. Do psycho-behavioural interventions improve mental and physical 
health in chronic kidney disease? A systematic review of randomised controlled trials. J Nephrol. 2025;38:2155-
2171.
10. Jeong J, Hu Y, Zanuzzi M, et al. Autonomic modulation with mindfulness-based stress reduction in chronic 
kidney disease: a randomized controlled trial. J Physiol. 2025;603(2):489-505.
11. Park J, Jeong J, Sabino-Carvalho JL, et al. Acute effects of mindfulness meditation on muscle sympathetic nerve 
activity and blood pressure in CKD. Hypertension. 2014;63(6):1101-1106.
12. Huberty J, Green J, Glissmann C, et al. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce 
Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019;7(6):e14273.
13. Huberty JL, Green J, Puzia ME, et al. Testing a mindfulness meditation mobile app for the treatment of sleep-
related symptoms in adults with sleep disturbance: A randomized controlled trial. PLoS One. 2021;16(1):e0244717.
14. Huberty JL, Espel-Huynh HM, Neher TL, Puzia ME. Testing the Pragmatic Effectiveness of a Consumer-Based 
Mindfulness Mobile App in the Workplace: Randomized Controlled Trial. JMIR Mhealth Uhealth. 
2022;10(9):e38903.
15. Smith RB, Mahnert ND, Foote J, et al. Mindfulness Effects in Obstetric and Gynecology Patients During the 
COVID-19 Pandemic: A Randomized Controlled Trial. Obstet Gynecol. 2021;137(6):1032-1040.
16. Ash GI, Nally LM, Stults-Kolehmainen M, et al. Personalized Digital Health Information to Substantiate 
Human-Delivered Exercise Support for Adults with Type 1 Diabetes. Clin J Sport Med. 2023.
17. Fucito LM, Ash GI, DeMartini KS, et al. A Multimodal Mobile Sleep Intervention for Young Adults Engaged in 
Risky Drinking: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021;10(2):e26557.
18. Ash GI, Robledo DS, Ishii M, et al. Using Web-Based Social Media to Recruit Heavy-Drinking Young Adults 
for Sleep Intervention: Prospective Observation. J Med Internet Res. 2020;22(8):e17449.
19. Griffith F, Ash G, Augustine M, et al. Leveraging Natural Language Processing to Evaluate Young Adults' User 
Experiences with a Digital Sleep Intervention for Alcohol Use. Nat Digit Med. 2024.
20. Fucito LA, Ash GI, Wu R, et al. Evaluating the Effect of a Novel Digital Sleep Intervention for Reducing At-
Risk Drinking in Young Adults. Under review.
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21. Hoge EA, Bui E, Mete M, et al. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of 
Adults With Anxiety Disorders. JAMA Psychiatry. 2023;80(1):13-21.
22. Viechtbauer W, Smits L, Kotz D, et al. A simple formula for the calculation of sample size in pilot studies. J 
Clin Epidemiol. 2015;68(11):1375-1379.
23. Laird B, Puzia M, Larkey L, Ehlers D, Huberty J. A Mobile App for Stress Management in Middle-Aged Men 
and Women (Calm): Feasibility Randomized Controlled Trial. JMIR Form Res. 2022;6(5):e30294.
24. Lukasik JL, Ash GI, Mak SS, Sherr JL, Fucito LM, Nally LM. Clinician Perspectives on Barriers to Mental 
Health Support and Digital Mindfulness Tools for Young Adults with Type 1 Diabetes: American Diabetes 
Association 2026 Scientific Sessions, Poster Presentation (In Review, Control # 2026-LB-4282-Diabetes). 
25. Remskar M, Western MJ, Ainsworth B. Mindfulness improves psychological health and supports health 
behaviour cognitions: Evidence from a pragmatic RCT of a digital mindfulness-based intervention. Br J Health 
Psychol. 2024 Nov;29(4):1031-1048. doi: 10.1111/bjhp.12745. Epub 2024 Aug 21. PMID: 39169217.
26. Radha M, de Groot K, Rajani N, et al. Estimating blood pressure trends and the nocturnal dip from 
photoplethysmography. Physiol Meas. 2019;40(2):025006.
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COMPOUND AUTHORIZATION AND CONSENT FOR PARTICIPATION 
IN A RESEARCH STUDY
YALE UNIVERSITY
YALE MEDICINE 
YALE-NEW HAVEN HEALTH
Study Title: The Mindful Kidney: A Digital Mindfulness Intervention for Adults with Chronic 
Kidney Disease 
Principal Investigator (the person who is responsible for this research): 
Garrett Ash, PhD (Principal Investigator), Assistant Professor of Medicine, Yale School of 
Medicine, Section of General Internal Medicine
100 Church Street South, Room F201c, New Haven, CT, 06519. Phone: 203-444-3079. Email: 
Garrett.Ash@yale.edu
Menaka Sarav, MD (co-Investigator), Assistant Professor of Medicine, Internal Medicine, 
Section of Nephrology.
Research Study Summary:

We are asking you to join a research study.

The purpose of this research study is to test a mindfulness app called Calm Health among 
adults with chronic kidney disease (CKD).

Study activities will include: using the mindfulness app for 6 weeks, wearing an actigraphy 
watch, answering surveys and interviews about the app, and receiving two health coaching 
check-ins.

Your involvement will require approximately 10 hours over 6 weeks (including app use of 45 
minutes per week).

There may be some risks from participating in this study. There is a chance that some 
people may find the survey questions a little upsetting. Mindfulness can uncommonly have 
negative mental health effects. A watch can rarely irritate some people’s skin. Finally, we 
take multiple steps to protect your confidentiality, but no study can guarantee that your 
information will remain confidential.

The study may have no benefits to you. The study will provide you with a free subscription to 
a mindfulness app until November 30, 2026, and mindfulness can have mental health 
benefits. However, the app and study may have no benefits to you. This study may help to 
improve mindfulness-based care for other adults with CKD in the future.

There are other choices available to you outside of this research. For example, you can 
purchase other mindfulness apps, go to a mindfulness class taught by a professional 
instructor, or read about mindfulness on the Centers for Disease Control and Prevention 
website.

Taking part in this study is your choice. You can choose to take part, or you can choose not 
to take part in this study.  You also can change your mind at any time.  Whatever choice you 
make, you will not lose access to your medical care or give up any legal rights or benefits 
and will not have any effect on your relationship with Yale University, Yale Medicine 
Nephrology, or the Yale New Haven Health system. 

If you are interested in learning more about the study, please continue reading, or have 
someone read to you, the rest of this document. Ask the study staff questions about 
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anything you do not understand. Once you understand the study, we will ask you if you wish 
to participate; if so, you will have to sign this form.
Why is this study being offered to me?
We are asking you to take part in a research study because you are an adult with chronic kidney 
disease who uses a home blood pressure monitor. We are looking for 26 participants to be part 
of this research study. 
Who is paying for the study? 
This study is funded by gift funds in the Section of Nephrology (Hollis Family). Calm Health is 
providing the study with app access for a much lower fee than regular customers.
What is the study about? 
The purpose of this study is to test a mindfulness app called Calm Health among adults with 
chronic kidney disease (CKD) for how well people like it and its influence on mental and 
physical health. In addition, we want to get your feedback on a new dashboard for the app that 
will help you track the relationship between mindfulness and your blood pressure, stress, and 
sleep.
What are you asking me to do and how long will it take? 
If you agree to take part, your participation in this study will involve:
Consenting Visit: Consent to the study. Survey of basic medical and demographic information 
like age, race, ethnicity, type of kidney disease, eGFR, height, and weight. We will access your 
medical record to verify this information. 
Week #0 Visit: Surveys about feelings, anxiety, stress, quality of life, and well-being. Learn to 
use the mindfulness app and start using it for 45 minutes per week. Learn how to place and 
charge study wristwatch (mailed in advance). The watch face is about 2 inches measured 
diagonally. It contains a silicon chip that senses movement and a green light on the back that 
senses blood flow. It will record physical activity, sleep duration, heart rate, heart rate variability, 
respiratory rate, skin temperature, and a signal used to estimate blood pressure trends. The 
watch does not display blood pressure readings; the research team will process the signal into 
estimates of your blood pressure patterns for your biometric report at the end of the study.
. 
Weeks #1, #2, #3, #4, #5 Surveys: Complete a short phone text survey about how the study is 
going and any problems or concerns. At Week #1 you will also receive a health coaching check-
in to help troubleshoot any barriers to using the app. At Week #4 you will receive a health 
coaching session using a motivational interviewing approach. 
Week #6 Visit: Mail back watch in prepaid box. Update medical and demographic information. 
Repeat surveys from Week #0. Complete survey and interview about how you liked the app. 
See a report of your mindfulness, blood pressure, stress, and sleep data. Complete think-aloud 
interview about how you liked the report. 
We think that the study will take approximately 10 hours over 6 weeks of your time.
Audio Recording
We request consent to audio record the interviews over Zoom at week #8 so that your answers 
can be transcribed for better analysis. No other parts of the study will be audio recorded. The 
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recordings will be converted to a written transcript as soon as a research team member is 
available to do so, and then the recording will be immediately destroyed. The transcript will be 
stripped of all information that could identify you such as your name and places you mention. 
__Yes, I agree to have my interviews recorded
__No, I decline to have my interviews recorded
Are there any risks from participating in this research?
If you decide to take part in this study, you may experience the possible risk of loss of 
confidentiality. Such loss is extremely rare when our standard steps to protect confidentiality are 
taken. 
There is a low risk that the wristwatch will contribute to skin irritation or allergies. We will show 
you how to keep the device dry, not wear it too tight, and remove it for an hour every couple of 
days. 
You may experience distress over the nature of the questions. Also, uncommonly, mindfulness 
can have negative mental health effects. Please inform us right away if you experience any 
emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual 
changes in mood or behavior. We will provide you with appropriate resources including 988 
(crisis line), 741741 (crisis text line), 211 (local social services), or 911 if you are in immediate 
physical danger, and connect you with a mental health provider. If you share that you have 
active thoughts, plans, or intentions to harm yourself or another person, we must take action for 
your safety. We will call 988, inform your primary provider, and you will be asked to stop 
participating in the study. The mindfulness app is a mental health wellness product. It is not 
intended to diagnose or treat depression, anxiety, or any other mental or physical condition. It is 
not a substitute for a healthcare provider. Any questions about the diagnosis, care, or treatment 
of a medical condition should be directed to a healthcare provider. The Calm app has been 
used in previous studies with other participant populations and no adverse events were 
reported, but there may be risks related to use of the Calm Health app that are currently 
unknown. There may be additional risks that are currently unforeseeable. 
How will I know about new risks or important information about the study?
We will tell you if we learn any new information that could change your mind about taking part in 
this study. 
The mindfulness app and watch that gather information for the report are not medical devices. 
The report will tell you about your health behaviors. It is not intended to diagnose, treat, or 
prevent any medical condition. Therefore, the study team will not notify you of any possible 
health issues indicated by device data.
How can the study possibly benefit me or others?
You may benefit from taking part in this study. The study will provide you with a free 
subscription to the Calm Health mindfulness app until November 30, 2026, and mindfulness 
practice may improve stress, anxiety, depression, sleep, and overall well-being. You will also 
receive two health coaching sessions and a personalized biometric report showing how your 
mindfulness practice relates to your blood pressure, sleep, and stress. However, the app and 
study may have no direct benefits to you.
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We hope that our results may add to the knowledge about how to engage more adults with 
chronic kidney disease into mindfulness and improve accessible mental health tools for this 
population. 
Are there any costs to participation? 
You will not have to pay for taking part in this study. You will not be responsible for costs related 
to watch damage or loss. The only costs may include your time coming to the study visits and 
data charges by your cell phone carrier.
If you do not own a smartphone, the study team will lend you one for the duration of the study. 
You will not be responsible for any costs if it is lost or damaged.
Will I be paid for participation? 
You will be paid for taking part in this study. You will receive $25 for completing the intake visit 
and $50 for completing the follow-up visit. You will also be paid $10 each week you complete the 
weekly survey and wear the watch at least 90% of the time. If you wear the watch 70%-89% of 
the time, you get $5 for that week. In summary, the maximum possible compensation is $135.
We will use a pre-paid debit card to provide payment for taking part in the study.  We will have 
to share your name, address, and telephone number with the banking institution issuing the 
debit card for ePayments. You may receive a card in the mail with the first payment following 
completion of the first visit. You will need to activate the card over the phone. Payments for 
additional visits will be automatically added to your card after completion of each following visit.  
You are responsible for paying state, federal, or other taxes for the payments you receive for 
being in this study. Taxes are not withheld from your payments.
What are my choices if I decide not to take part in this study?
Instead of participating in this study, you have some other choices. You could:

Purchase other mindfulness apps.

Go to a mindfulness class taught by a professional instructor

Read about mindfulness on the Centers for Disease Control and Prevention website.

Take part in another study.

Choose not to participate in research. 
How will you keep my data safe and private?
All of your responses will be held in confidence. Only the researchers involved in this study and 
those responsible for research oversight (such as representatives of the Yale University Human 
Research Protection Program, the Yale University Institutional Review Boards, and others) will 
have access to any information that could identify you that you provide. All research materials are 
stored on secure, password-protected servers. Also, your data will be coded with an anonymous 
study number. Things that could identify you like your name, address, or phone number will be 
stored separately and only one code key will link these identifiers to your data. That code key will 
be destroyed 1-2 years from now. The non-identifying data will be kept indefinitely. We will share 
it with others if you agree to it or when we have to do it because U.S. or State law requires it. For 
example, we will tell somebody if we learn that you are hurting a child or an older person.
When we publish the results of the research or talk about it in conferences, we will not use your 
name. If we want to use your name, we would ask you for your permission. 
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We will also share information about you with other researchers for future research but we will 
not use your name or other identifiers. We will not ask you for any additional permission. Identifiers 
will be removed from the identifiable private information and after such removal, the information 
could be used for future research studies or distributed to another investigator for future research 
studies without additional informed consent from you. 
Calm Health will collect data about your phone number and IP address, your name if you choose 
to enter it, date of birth, and how you use the app. This data will be shared with the Yale research 
team. Calm Health's use of this data is governed by their privacy policy and a Data Use Agreement 
with Yale University; they will not use it to identify you personally in connection with this research 
or put you on a contact list that is sold to third parties. Calm Health may use your aggregated, de-
identified data for product improvement and other purposes that lead to commercial profit, which 
may include selling the data to third parties. You will not share in this profit. Once de-identified, 
the data cannot be linked back to you. 
The Yale research team will not provide Calm Health with research results beyond what we 
provide the public.
If you are open to being contacted about our future studies in which you could participate, we can 
keep your contact details for this purpose in a separate location from your data. Please indicate 
here whether we have your permission to recontact you for future studies. If you give this 
permission, we will retain you on the list indefinitely by default but you can ask to be removed at 
any time.
Yes______
No______
Investigator Interest
Dr. Garrett Ash, principal investigator for this study, is a scientific advisor to Behavioral Health 
Tech Innovations LLC and has a provisional patent filed for a digital system for lifestyle medicine 
(047162–5346-P1US). 
Dr. Frances Griffith, co-investigator for this study, is a consultant for Calm Health and clinical 
author of their chronic kidney disease module of mindfulness exercises.
You may contact research staff at any time and make an appointment to speak with Dr. Ash or 
Dr. Griffith should you have questions regarding these investigator interests.
What Information Will You Collect About Me in this Study?
The information we are asking to use and share is called “Protected Health Information.” It is 
protected by a federal law called the Privacy Rule of the Health Insurance Portability and 
Accountability Act (HIPAA). In general, we cannot use or share your health information for 
research without your permission. If you want, we can give you more information about the Privacy 
Rule. Also, if you have any questions about the Privacy Rule and your rights, you can speak to 
Yale Privacy Officer at 203-432-5919.
The specific information about you and your health that we will collect, use, and share includes:
• Research study records
• The entire research record and any medical records held by Yale New Haven Health 
created from your first encounter with them to the end of your participation in this study.
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• Records about phone calls made as part of this research
• Records about your study visits
• Information obtained during this research regarding

Questionnaires and interviews

The diagnosis and treatment of a mental health condition

Records about your use of the study app

Data about your physical activity, sleep, heart rate, and nervous system 
stress recorded by the watch

Blood pressure data from your home monitor

Laboratory results (eGFR, metabolic panel, lipid panel, glucose measures, 
cystatin C) and vital signs (blood pressure, height, weight) from your 
medical chart

Diagnoses and medications from your medical chart

Calm Health will access information that could identify you including your 
phone number and IP address to connect to your phone, your date of birth, 
and your first and last name if you choose to enter them into your profile
How will you use and share my information?
We will use your information to conduct the study described in this consent form. 
We may share your information with:
•
The U.S. Department of Health and Human Services (DHHS) agencies
•
Representatives from Yale University, the Yale Human Research Protection Program and 
the Institutional Review Board (the committee that reviews, approves, and monitors 
research on human participants), who are responsible for ensuring research compliance.  
These individuals are required to keep all information confidential. 
•
Health care providers who provide services to you in connection with this study.
•
The Calm Health app you use in this study.
•
Other individuals and organizations that analyze your health information in connection with 
this study, according to the study plan.
•
Principal Investigator of the study
•
Co-Investigators and other investigators 
•
Study Coordinator and Members of the Research Team 
We will do our best to make sure your information stays private. But, if we share information with 
people who do not have to follow the Privacy Rule, your information will no longer be protected 
by the Privacy Rule. Let us know if you have questions about this. However, to better protect your 
health information, agreements are in place with these individuals and/or companies that require 
that they keep your information confidential.
Why must I sign this document?
By signing this form, you will allow researchers to use and disclose your information described 
above for this research study. This is to ensure that the information related to this research is 
available to all parties who may need it for research purposes. You always have the right to review 
and copy your health information in your medical record. 
What if I change my mind?
The authorization to use and disclose your health information collected during your participation 
in this study will never expire.  However, you may withdraw or take away your permission at any 
time. You may withdraw your permission by telling the study staff or by writing to Garrett Ash, 
PhD, Yale School of Medicine, Section of General Internal Medicine, 100 Church Street South, 
Room F201c, New Haven, CT, 06519.
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If you withdraw your permission, you will not be able to stay in this study but the care you get from 
your doctor outside this study will not change.  No new health information identifying you will be 
gathered after the date you withdraw. Information that has already been collected may still be 
used and given to others until the end of the research study to ensure the integrity of the study 
and/or study oversight. 
Who will pay for treatment if I am injured or become ill due to participation in the study? 
If you are injured while on study, seek treatment and contact the study doctor as soon as you are 
able. Yale School of Medicine and Yale-New Haven Hospital do not provide funds for the 
treatment of research-related injury.  If you are injured as a result of your participation in this 
study, treatment will be provided.  You or your insurance carrier will be expected to pay the costs 
of this treatment.  No additional financial compensation for injury or lost wages is available. You 
do not give up any of your legal rights by signing this form.
What if I want to refuse or end participation before the study is over? 
Taking part in this study is your choice. You can choose to take part, or you can choose not to 
take part in this study.  You also can change your mind at any time.  Whatever choice you 
make, you will not lose access to your medical care or give up any legal rights or benefits. Not 
participating or withdrawing later will not have any effect on your relationship with Yale 
University, Yale Medicine Nephrology, or the Yale New Haven Health system.
Not participating or withdrawing later will not harm your relationship with your own doctors or 
with this institution.
To withdraw from the study, you can call a member of the research team at any time and tell 
them that you no longer want to take part.
The researchers may withdraw you from participating in the research if necessary. This may 
happen if you do not follow study procedures or if the researchers determine it is unsafe or 
against your best interests to continue. If you stop completing the mindfulness exercises, it is 
still important that you make every effort to attend the week #6 study visit.
What will happen with my data if I stop participating? 
You will cease to provide data, but cannot withdraw data you have already provided. If you 
continue using Calm Health, those data will continue to be captured. 
Who should I contact if I have questions? 
Please feel free to ask about anything you don't understand. 
If you have questions later or if you have a research-related problem, you can call the Principal 
Investigator at 203-444-3079. 
If you have questions about your rights as a research participant, or you would like to speak with 
someone other than the Principal Investigator or study team to discuss problems, concerns, or 
questions, or to obtain information or offer suggestions, you can call the Yale Institutional 
Review Boards at (203) 785-4688 or email hrpp@yale.edu.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time.
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Yale 
University 
is 
committed 
to 
accessibility 
(https://usability.yale.edu/web-
accessibility/accessibility-yale). Please contact the study team at 203-444-3079 if you have 
trouble accessing content of the Calm app. 
Authorization and Documentation of Consent
Your signature below indicates that you read and understand this consent form and the 
information presented and that you agree to be in this study.  
We will give you a copy of this form.
Participant Printed Name
Participant Signature
Date
Person Obtaining Consent Printed Name
Person Obtaining Consent Signature
Date
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