The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate Predisposing Factors of Suicidal Ideation in Nurses
Phase: NA
Conditions: Suicide, Nurse's Role, Work Environment Adverse Effects, Sleep, Stress, Mental Health Wellness 1
Sponsor: Columbia University

COVER PAGE 
NCT06079853 
Study Title: The Use of Physiologic Measures and Sleep Health Promotion to Identify and Mitigate 
Predisposing Factors of Suicidal Ideation in Nurses 
PI: Allison A. Norful, PhD, RN, ANP-BC, FAAN 
PI Contact: aan2139@cumc.columbia.edu 
Sponsor: Columbia University School of Nursing 
Date of Protocol Approval: 10/18/2023

STUDY PROTOCOL 
The purpose of this study is to generate longitudinal pilot data that investigates 1) which factors (stressful life 
events, psychiatric characteristics, and work environment characteristics) are associated with stress and 
subsequent suicidal ideation; and 2) to explore the preliminary impact of an existing evidence-based sleep 
intervention, Somni©14, on stress, psychological health, and suicidal ideation in working nursing 
professionals. The specific aims are: 
Aim 1. To investigate associations between sleep, stressful life events (life stressors, discrimination, 
lateral violence), psychiatric characteristics (psychiatric diagnosis, subjective mood), work 
environment characteristics (workload, shift type and duration, overtime, nurse work environment, 
and team relations) and stress (self-reported and heart rate variability) in working nursing 
professionals while controlling for standard covariates known to influence stress. Hypothesis 1: 
Suboptimal work environment characteristics are positively associated with self-report and physiologic 
indicators of stress [heart rate variability (HRV)]. Hypothesis 2: Poor sleep (duration and quality) will be 
positively associated with self-report and physiologic indicators of stress (HRV). 
Aim 2. To determine if stress exposure (self-report and HRV) are associated with predisposing 
factors (sleep, stressful life events, additional psychiatric characteristics, and work environment 
characteristics), and to explore whether stress mediates the effect of predisposing factors on 
suicidal ideation in working nursing professionals. Hypothesis: Nurses with low HRV are at higher risk 
for suicidal behavior when exposed to poor sleep, the presence of psychiatric characteristics (e.g. 
Depression), stressful life events, or suboptimal work environment characteristics (e.g., poor team 
relations). 
Exploratory Aim. To explore the preliminary impact of an existing sleep intervention (Somni©) on self- 
reported stress, HRV, sleep, and psychiatric health outcomes including depression, burnout, and 
suicidal ideation. 
 
STUDY DESIGN. This study is a prospective pragmatic pilot trial to generate data needed to inform a fully-
powered longitudinal study consisting of nurses across a wider geographic region.  There are 4 study 
components:  
1. Electronic Quantitative Surveys (baseline, Week 4 & Week 8) will consist of demographic questions and 
validated measures for personal characteristics, sleep, stressful life events, psychiatric characteristics, work 
environment factors, and all psychological health outcomes. (Table 1). The surveys will be administered 3 
times (baseline, week 4 and week 8) to generate pilot longitudinal data.  
2. Psychological Assessment (baseline). To confirm a preexisting psychiatric diagnosis, a Structured 
Clinical interview for DSM-5 Diagnosis (Research version) (SCID-5-RV) will be administered in-person by a 
Psychiatric Mental Health Nurse Practitioner (PMHNP) at baseline. SCID-5-RV is a semi-structured interview 
guide for making major DSM-5 diagnoses such as mood disorders, psychotic symptoms, substance use, 
sleep, and trauma- or stressor-related disorders and takes approximately 45-60 minutes to administer. 
Studies suggest that prior history of mental illness, such as depression, has been linked to suicide.  
3. Physiologic Biomarkers (Weeks 1-8). Heart rate and sleep (hours/day) will be collected using a wearable 
device, Oura ring©, a piece of jewelry that can be custom fit to each participant. Heart rate variability (HRV), a 
highly sensitive physiologic metric for stress, is the constant variation in milliseconds between beats, and 
controlled by the autonomic nervous system. Low HRV is a strong indicator of physiologic stress (fight or flight 
response) and has been associated with increased risk for suicide attempt. Studies have demonstrated high 
validity in the assessment of HRV and sleep using the Oura ring©. The device will also collect activity levels 
(steps/day) and sleep cycles, known confounders for stress levels.  

 
4. Sleep Intervention (Weeks 4-8) Somni© is an evidence-based personalized sleep intervention aimed at 
promoting optimal sleep health and has demonstrated effectiveness in shift workers outside the healthcare 
sector (e.g. Disney). Somni© consists of a sleep kit and a smart phone application. The sleep kit is box of 
items with demonstrated past evidence of improving sleep health: Blue light blocking glasses, white noise 
machine, lavender spray, ear plugs, light blocking eye mask, and herbal tea. Rather than dictate a “one size 
fits all” approach to optimize sleep health, there is current evidence that individualized sleep interventions are 
recommended to optimize sleep quality. Somni© permits individualized sleep quality promotion and 
participants are able to select their preferred use, timing, and duration of each of the box contents. The kit is 
accompanied by a Somni© smartphone app that prompts participants to input the use of each component in 
the kit and provide a subjective sleep quality rating each day. Drs. Norful and Shechter have partnered with 
the developers of Somni© who will provide free sleep kits and app access to our study participants. The 
Somni© app is interoperable with the Oura Ring© and will automatically sync all physiologic and sleep data 
together in one location, fully accessible to the participants, and displayed in graphs in the Somni© app that 
are easy to read and interpret (e.g. total daily steps; daily sleep hours). Somni© will be implemented Weeks 4 
through 8 to investigate its preliminary impact on stress and suicidal ideation by comparing survey and 
physiologic metrics from Weeks 1-4.  
 
STATISTICAL ANALYSIS 
First, we will calculate composite scores of individual measures (sleep, stressful life events, psychiatric 
characteristics, and work environment characteristics). Descriptive statistics will be calculated including means 

𝑌𝑌 
and standard deviations (normally distributed values), median and interquartile range (non- normally distributed 
variables), or absolute and relative frequencies (categorical variables). Outliers and missing data will be 
assessed (outliers > 3 standard deviations from the mean will be removed). Significance level will be set at 𝛼𝛼 = 
0.05.  
Aim 1. We will calculate bivariate Pearson or Spearman’s rank order correlation coefficients as well as simple 
linear regression and univariate ANOVAs. We will use linear mixed models to examine the relationships 
between individual and composite scores of factors (sleep, stressful life events; psychiatric characteristics; 
work environment characteristics) and 1) self-report stress and 2) HRV, while controlling for personal 
characteristics (age, sex, highest degree earned, years of experience, years of practice in current environment, 
smoking status). We propose the following model to test all hypotheses:  
   𝑔𝑔[𝐸𝐸( 𝑖𝑖)] = 𝛽𝛽𝑜𝑜 + 𝛽𝛽1𝑋𝑋𝑖𝑖 + 𝛽𝛽2𝐹𝐹 where Y𝑔𝑔 represents the outcomes measure (self-report and HRV separately) for 
each participant i. Xi are the individual-level covariates (e.g., sex, gender, race, age, mental health history), 𝐹𝐹 
represents each job stressor and work environment variable. As the primary outcome is stress (mean score 
and mean HRV), possible distributions such as Poisson, zero-truncated Poisson, negative binomial, or zero- 
truncated negative binomial will be assessed to determine the best fit link function.  
 
Aim 2. We will classify nurses into quartiles of high (top 25%), medium (middle 50%), and low (bottom 25%) 
HRV. We will use descriptive statistics to examine individual measures and composite scores of factors (sleep, 
stressful life events, psychiatric characteristics, work environment characteristics) and suicidal behavior [C-
SSRS score]). To evaluate the change in suicidal ideation over time and the impact of each factor composite 
score, we will fit conditional latent growth curve models using 3 data points. The models will be expressed such 
that, given mean HRV and baseline composite scores for each factor category: 𝑦𝑦𝑖𝑖𝑖𝑖 = (𝜇𝜇𝑎𝑎 + 𝜇𝜇𝛽𝛽𝜆𝜆𝑡𝑡  + 𝛾𝛾1𝐻𝐻𝐻𝐻𝐻𝐻𝑖𝑖  + 
𝛾𝛾2𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖) + (𝜁𝜁𝑎𝑎𝑎𝑎 + 𝜁𝜁𝛽𝛽𝛽𝛽𝜆𝜆𝑡𝑡) + 𝜀𝜀𝑖𝑖𝑖𝑖 where 𝑦𝑦𝑖𝑖𝑖𝑖 is the C-SSRS score for nurse i at time t, 𝜇𝜇𝑎𝑎 is the latent variable for 
the intercept value (baseline score), 𝜇𝜇𝛽𝛽 is the random latent variable for slope (growth over time) for nurse i 
multiplied by the vector of factor loadings specifying time, 𝜆𝜆𝑖𝑖𝑖𝑖, 𝜀𝜀𝑖𝑖𝑖𝑖 is the time-specific residual for nurse I, 𝜁𝜁𝑎𝑎𝑎𝑎 
and 𝜁𝜁𝛽𝛽𝛽𝛽𝜆𝜆𝑡𝑡 are random components of the latent intercept and slope variables, respectively. Sleep, stressful life 
events and psychiatric characteristics are fixed (time-invariant) predictors. The factor loadings for time on slope 
can be fixed to adjust for gaps in outcomes, which would allow for modeling more distant (e.g., 2025) data from 
baseline without increasing the number of timepoints included in the model. Further, we anticipate fluctuations 
in HRV over time. To accommodate the change in trend, we will explore both linear and quadratic growth 
functions. Baseline global sleep scores (PSQI), stressful life events, psychiatric and work environment 
characteristics will serve as predictors of suicidal ideation change over time. Individual nurse characteristics 
and psychiatric characteristic controls will be included as an interaction term to compare curves across nurses. 
To explore whether stress mediates the effect of predisposing factors on suicidal ideation, we will compare the 
models assessing the effect of predisposing factors on suicidal ideation with and without the mediator outlined 
by Barron and Kenny difference method which be used to gauge the size of the mediation effect.  
 
Aim 3. We will calculate descriptive statistics, percentages, and frequencies for 1) each Somni© sleep kit 
component 2) subjective sleep quality via Somni© app 3) global sleep scores (PSQI score) and HRV. We will 
test differences in global sleep scores (PSQI), mean sleep duration (Oura ring), mean subjective sleep quality 
and use of sleep kit components at the individual level between the 3 data points. We will report the effect 
sizes and will test for significance in the model for each psychosocial and work environment factor, each 
Somni© sleep kit component (mean weekly frequency), and the mean PSQI score while controlling for age, 
sex, gender, race, and history of psychiatric diagnosis. We will repeat the same analysis modeling mean C-
SSRS as the dependent variable. To evaluate the change in suicidal behavior over time and the impact of 
global sleep (PSQI score) and each Somni© sleep kit component (mean weekly frequency), we will fit 
conditional latent growth curve models. 

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Columbia University Consent Form 
 
 
 
 
Attached to Protocol: IRB-AAAU3204 
Principal Investigator: Allison Norful (aan2139) 
IRB Protocol Title: The use of physiologic measures and sleep health promotion to identify and mitigate predisposing 
factors of suicidal ideation in nurses: A pilot pragmatic trial 
 
Consent Number: CF-AACQ1190 
Participation Duration: 8 weeks 
Anticipated Number of Subjects: 25 
 
Research Purpose: The overall purpose of this study is to identify factors (sleep, psychiatric characteristics, stressful 
life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors 
that predispose nurses to suicidal risk, among other psychologic conditions. 
 
 
 
Contact 
Title 
Contact Information 
Allison Norful 
Principal Investigator 
Phone: 
212-305-7157 
Cell: 
516-477-9444 
Email: 
aan2139@cumc.columbia. 
edu 
 
 
Key Information  
 
This consent is being sought for research and participation is voluntary. 
 
Study Summary: We are currently recruiting participants for a study that aims to explore the associations between 
sleep, stressful life events, psychiatric characteristics (mood, depression, burnout), work environment factors (staffing 
ratios, leadership support, team relations) and physiologic stress that may precipitate or prevent suicidal risk. We also 
aim to test the impact of an evidence-based sleep health promotion intervention. 
 
Main Study Procedures & Duration: Over the course of 8 weeks, you will be asked to complete the following:  
1) Electronic surveys at baseline, week 4 and week 8 (25-40 minutes each). Survey consist of validated 
instruments to measure aspects of your personal and professional life. It will include mental health screening for 
depression, anxiety, and suicidal ideation/behavior.  
Protocol Information 
General Information 
Contacts 
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2) One-time Structured Clinical Interview for DSM-V disorders (45-60 minutes) administered at baseline by a 
Psychiatric Mental health Nurse Practitioner. This semi-structured interview is used for diagnosing mood or 
psychotic disorders, substance use, sleep and trauma- or stress-related disorders. 
3) Measurement of Heartrate and sleep using a wearable jewelry device called the Oura ring. The Oura ring 
is worn on your ring finger and using nanotechnology and sensors, can capture your activity level, heart rate, 
respiration, and sleep.  You will be asked to wear the ring for 8 weeks. 
4) Sleep health promotion intervention. During weeks 4-8 you will have the opportunity to use one or more sleep 
health promotion items including eye mask, white noise machine, aromatherapy lavender spray, blue blocking 
glasses, sun-blocking window shade, herbal tea and ear plugs. You will have the opportunity to select which 
item(s) you would like to use.  
 
Duration of participation; 8 weeks 
 
Risks or discomforts to the prospective subject. There may be mild skin irritation while wearing the Ouraring. The 
survey and/or structured clinical interview may elicit some emotional responses when inquiring about mood or 
psychological wellbeing.  
 
Benefit(s), if any; There are no direct benefits. However, the sleep health promotion kit includes items that may 
improve sleep efficiency and effectiveness. You may keep the sleep health promotion kit at not cost to you.  
 
Alternative procedures: This study is voluntary and as an alternative, you may choose not to participate. If you would 
like any information about free mental health resources, the study team will provide you with information at any time 
regardless of participation in this study. 
 
 
INTRODUCTION 
 
Consent is being sought for research and participation is voluntary. 
        The purpose of this form is to give you information to help you decide if you want to take part in a research study. 
        This consent form includes information about: 
-     why the study is being done; 
-      the things that you will be asked to do if you are in the study; 
-      any known risks involved; 
-      any potential benefit; 
-      options, other than taking part in this study, that you have. 
The principal investigator (the lead researcher for this project) [Dr. Allison A. Norful and/or Site Lead, Margaret Adler] 
will discuss the study with you. If at any time you have questions about the study, please ask a member of the study 
team. Take all the time you need to decide whether you want to take part in this research study. 
 
 
Information on Research 
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The overall purpose of this study is generate pilot data that investigates 1) which factors (stressful life events, 
psychiatric characteristics, and work environment characteristics) are associated with stress and subsequent suicidal 
ideation in working nursing professionals; and 2) to explore the preliminary impact of an existing evidence-based 
sleep health promotion kit intervention, called Somni©. 
Study procedures:  
a, Data collection will occur at baseline, week 4 and week 8. The total duration of study participation is 8 weeks. 
 
b. How many nurses are participating in this study? We are current enrolling 25 nurses in this pilot study.  
 
c. What does participation entail? Participation will include the following:  
 
Baseline: Structured Clinical Interview- DSM-V (45-60 minutes); Baseline Electronic Survey (25-40 minutes); Start 
 
use of the OuraRing for 8 weeks. 
      Week 4: Recurring Electronic Survey (25-40 minutes); Start to use the  Sleep Health Promotion Kit. 
 Week 8: Recurring Electronic Survey (25-40 minutes); Stop use of Oura Ring and Sleep Health Promotion. End of 
study participation.  
 
d. What is the Oura ring? This publicly available device is a piece of jewelry (ring) worn on your ring finger. Using 
nanotechnology and sensors, the ring can capture your activity level, heart rate, respirations, and sleep. Your data is 
automatically uploaded to the Oura server for download by the study team. The ring should not be worn (and should 
be removed) during bathing, showering, or swimming. The ring will be provided to you for the duration of your 
enrollment in the study and needs to be returned to the study team when the study ends, you withdraw, or at the 
discretion of the study team. You will be asked to wear the Oura ring for all 8 weeks of study participation. 
 
e. What is the Somni© Sleep Health Promotion Kit? This kit, publicly available and marketed by a company called 
Somni©, consists of multiple items that may improve the effectiveness and efficiency of sleep health. The contents of 
the kit include an eye mask, white noise machine, aromatherapy lavender spray, blue blocking glasses, sun-blocking 
window shade, herbal tea and ear plugs.  You will be asked to use the sleep kit items (you may choose which to use 
and not to use) during week 4 through 8. You may keep the kit at no cost to you.  
 
f. What will the surveys ask? The electronic surveys will be accessible to you on any electronic device with internet 
access. The survey consists of multiple instruments to capture aspects of your personal and professional life, 
including stressful life events, professional characteristics (perceived workload, nursing work environment, teamwork, 
burnout), stress levels, sleep quality and duration, and psychological wellbeing (screen for depressive mood, suicidal 
thoughts and/or behaviors). 
 
g. Who is eligible to participate? 
Eligibility criteria are: 1) currently practicing as a registered nurse in the clinical setting; 2) have worked continuously in 
the same position for at least 6 months; and 3) read, speak, and understand English language.  Participants will be 
excluded if 1) >1-month sick leave in the past 3 months; 2) pregnancy (known physiologic stress confounder); and 3) 
other healthcare workers (e.g., physicians).  
 
h. Mental health resources: We will provide a collective list of free and accessible mental health resources including 
but not limited to psychiatry referrals and consultations, confidential suicide and mental health toll-free hotlines, and 
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employee-based resources such as CopeColumbia. This list will be provided upon enrollment and then listed at the 
end of each survey. In addition, the study team will be able to provide this information to you via email at any time for  
the duration of the study.  
 
Are there any risks? 
 
You may feel uncomfortable when answering some of the clinical interview questions or surveys that inquire about 
your past medical and psychiatric history, stressful life events, history of trauma, and work environment 
characteristics. You can choose to skip questions take a break when completing the sruvey if they make you 
uncomfortable, and return to complete it at a later time.A list of free mental health resources will be made 
available to you upon enrollment and also included at the end of each of the electronic surveys. In addition, the 
study team will be available to you if you need assistance with finding or navigating these resources. 
 
Participation involves wearing a piece of jewelry (Oura Ring) for 8 weeks and may cause minor discomfort or the 
potential for skin irritation at the site. You may discontinue use at any time and notify the research team. 
 
The components of the sleep health promotion box consist of interventions such as a light blocking glasses, sleep 
mask and lavender spray that may cause minor skin irritation. You will also receive an herbal tea. All allergies must be 
reported to the study at the start of the study. The use of any components of the sleep promotion box are voluntary. 
You may keep this box at the completion of the study. 
 
Loss of confidentiality 
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of privacy means having 
your personal information shared with someone who is not on the study team and was not supposed to see or know 
about your information. The study team plans to protect your privacy. Their plans for keeping your information private 
are described in the Privacy section of this consent form. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
 
You may or may not receive personal (direct) benefit from taking part in this study. The possible benefits of taking part 
in this study include sleep health promotion through the use of the Somni Sleep Kit components that have previous 
evidence supporting their use. 
 
You will not receive personal (direct) benefit from taking part in the electronic surveys or collection of your physiologic 
data through the OuraRing. However, the information collected from this research may help others in the future as we 
aim to understand what factors put nurses at higher risk for poor psychological health outcomes. 
 
WHAT OTHER OPTIONS ARE THERE? 
 
You may choose not to take part in this research study. Your decision to participate or not participate will in no way 
impact your employment. 
Risks 
Benefits 
Alternative Procedures 
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WHAT ABOUT CONFIDENTIALITY? 
 
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. 
Any information collected during this study that can identify you by name will be kept confidential. We will do 
everything we can to keep your data secure, however, complete confidentiality cannot be promised. Despite all of our 
efforts, unanticipated problems such as a stolen computer may occur, although it is highly unlikely. 
 
If you choose to take part in this study, you are giving us the authorization (i.e. your permission) to use the protected 
health information and information collected during the research that can identify you. The health information that we  
 
may collect and use for this research may include medical information that may be considered sensitive, including 
mental health screening for depression, anxiety, and suicidal ideation and/or behavior.  
 
Any research information that is shared with people outside of Columbia University Medical Center and NewYork-
Presbyterian Hospital will not include your name, address, telephone number or any other direct identifiers unless 
disclosure of the information is required by law or you have authorized the disclosure. 
 
Your safety is our priority. In the event that you exhibit or screen positive for active health risk and immediate 
intervention is required (e.g., active suicidal behavior), we will break confidentiality and contact your health provider, 
family or designated emergency contact, and/or call 911 to assist you with seeking a higher level of care. A copy of 
mental health resources will be provided to you at time of enrollment, in the form of a pocket guide, and located at the 
end of each survey. Should you require assistance with any mental health referrals at any time throughout the study, 
you may contact any study personnel for more information. 
 
Your survey responses, health information, and OuraRing data will be assigned a code number, and separated from 
your name or any other information that could identify you. The research file that links your name to the code number 
will be kept in an encrypted data file, a password-protected computer and only the investigator and authorized study 
staff will have access to the file. 
 
The following individuals and/or agencies will be able to look at, copy, use, and share your research information: 
- The investigator, study staff and other medical professionals who may be evaluating the study 
- Authorities from Columbia University or NewYork-Presbyterian Hospital including the Institutional Review Board 
('IRB') 
- The Federal Office of Human Research Protections ('OHRP') and/or the Federal Drug Administration ('FDA') 
 - The sponsor of this study, [Columbia University School of Nursing], including persons or organizations working with 
or owned by the sponsor 
- Data and Participant Safety Monitoring Committee 
-OuraRing representatives assisting with the acquisition of biologic data collected by the device (coded data only). 
 
The data collected by the OuraRing (heart rate, sleep patterns, activity levels) will not have any personal identifiers on 
the server to protect your privacy. Your data will be housed on the OuraRing server until the PI downloads all of your 
Confidentiality 
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data at the end of the study period for group analysis. Upon completion of your participation, your OuraRing will be 
deactivated and will not hold any of your personal data. The data downloaded from the study will be stored on a 
password protected, encrypted network drive at Columbia University, and only accessible to authorized study team 
members. 
 
Your authorization to use and share the information collected for this research purpose does not have an expiration 
(ending) date. Once your research information has been disclosed to a third party (for example, a pharmaceutical 
company participating in a study), federal privacy laws may no longer protect it from further disclosure. 
 
Also, even if you revoke (take back) this consent and authorization, the researchers and the sponsor (if applicable) 
may continue to use and disclose the information they have already collected. 
 
WHAT ABOUT FUTURE USE? 
Identifiers might be removed from the identifiable private information or identifiable biospecimens and, after such 
removal, the information or biospecimens could be used for future research studies or distributed to another investigator 
for future research studies without additional informed consent. 
 
Your authorization for the PI study team to use and share your de-identified health information or survey responses 
does not have an expiration (ending) date. In the future, your de-identified responses to the study and physiologic data 
(heart rate, activity levels or sleep patterns) may be combined with data from future groups of participants in larger 
studies to continue investigating the same study purpose. 
 
You may change your mind and revoke (take back) this consent and authorization at any time and for any reason. To 
revoke this consent and authorization, you must contact the Principal Investigator, Allison Norful (212-305-7157/ 
aan2139@cumc.columbia.edu) OR Co-Investigator, Margaret Adler (mma9026@nyp.org). 
 
However, if you revoke your consent and authorization, you will not be allowed to continue taking part in the Research. 
Also, even if you revoke this consent and authorization, the Researchers and the Sponsor (if applicable) may continue 
to use and disclose the information they have already collected. 
 
 
Will I get paid or be given anything to take part in this study? 
 
You will be compensated up to $100 for participation in this study. Incremental gift cards will be distributed upon 
completion of each study phase indicated below: 
 
Baseline visit including SCID-V interview and baseline survey: $25 gift card 
4-week data point (including OuraRing use and survey): $25 gift card 
8-week datapoint (incuding OuraRing use and survey): $50 gift card 
 
 
 
 
Compensation 
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Additional Costs 
 
 
There are no costs to you for taking part in this study. 
 
Taking part in this study will not involve additional costs to you. All devices, surveys, or materials (sleep health promotion 
kits) will be given free of charge by the sponsor company and study team. You and/or your insurance company will have 
to pay for any costs that are part of your regular medical care, emergency or urgent care, psychiatric wellness visits not 
offered by the free mental health resources provided through your employment. 
 
 
DO I HAVE TO BE IN THE STUDY? 
Taking part in this study is your choice. You may refuse to take part in the study or withdraw from the study at any time 
without jeopardizing your employment, or any other rights. The investigator may withdraw you at his/her discretion in 
the event that you are not completing the study procedures detailed in this form. 
 
What if you have questions? 
 
You may ask questions at any time. You can ask now or later. You may talk to the researcher or someone else. If you 
have any questions about this study you can call or email 
 
Allison Norful (Principal investigator) 
telephone #212-305-7157 
email: aan2139@cumc.columbia.edu 
Margaret Adler (Co-Investigator) 
telephone #914-734-3778 
email: mma9026@nyp.org. 
 
If you have any questions about your rights when you are in a research study, you may contact the Institutional Review 
Board by mail, telephone, or email at: 
 
Human Research Protection Office 
Institutional Review Board 
Columbia University 
154 Haven Avenue, 2nd Floor 
New York, NY 10032 
Telephone: (212) 305-5883 
Email: irboffice@columbia.edu 
 
An Institutional Review Board is a committee organized to protect the rights and welfare of human subjects involved in 
research. More information about taking part in a research study can be found on the Columbia University IRB 
website at: http://www.cumc.columbia.edu/dept/irb. 
Voluntary Participation 
Additional Information 
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Statement of Consent 
 
I have read the consent form and talked about this research study, including the purpose, procedures, risks, benefits 
and alternatives with the researcher. Any questions I had were answered to my satisfaction. I am aware that by signing 
below, I am agreeing to take part in this research study and that I can stop being in the study at any time. I am not 
waiving (giving up) any of my legal rights by signing this consent form. I will be given a copy of this consent form to 
keep for my records. 
 
Participant Signature Lines 
Study Subject 
Print Name  
Signature 
 
Date   
 
 
 
Research Signature Lines 
 
Person Obtaining Consent 
Print Name  
Signature 
 
Date   
 
Statement of Consent 
Signatures 
IRB-AAAU3204 (Y02M00)
For use until: 10/17/2024
IRB Approval Date: 10/18/2023