Digital Interventions to Treat Hazardous Drinking
Phase: NA
Conditions: Hazardous Drinking, Stress
Sponsor: Yale University

 
 
 
 
DIGITAL INTERVENTIONS TO TREAT HAZARDOUS DRINKING 
NCT04890652 
PROTOCOL VERSION DATE 9/4/2022 
 

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HRP-503B – BIOMEDICAL RESEARCH PROTOCOL  
(2017-1) 
 
 
 
 
Protocol Title:  Effects of Stress on Emotion and Risky Drinking 
 
 
Principal Investigator: Dongju Seo, PhD 
 
 
(If applicable) Clinicaltrials.gov Registration #: Click or tap here to enter text. 
 
 
SECTION I: RESEARCH PLAN 
 
1. Statement of Purpose:  
 
Studies have shown that stress is a major contributor to stress-related clinical disorders and to substance use 
problems including alcoholism (Perkins, 1999; Sebena, El Ansari, Stock, Orosova, & Mikolajczyk, 2012). Stress 
response involves increased arousals in the autonomic nervous system (ANS)  (Thayer, Ahs, Fredrikson, 
Sollers, & Wager, 2012). In particular, it is well documented that alcoholism is highly associated with stress 
and ANS disruption, suggesting that a strategy to address stress and ANS regulation may be helpful to reduce 
symptoms related to stress, mood, and addiction. For example, a breathing technique has shown to be 
effective in relieving stress-induced arousal. Studies have found that voluntarily regulated breathing practices 
normalize ANS system and improve sympatho-vagal balance, which resulted in reduction in psychiatric 
symptoms including anxiety, stressor-related symptoms, and addiction (Gerbarg & Brown, 2016). Relieving 
stress and arousal is particularly crucial in preventing alcohol addiction, as an inability to relax even during the 
neutrally relaxing state has been associated with high alcohol craving and early relapse in patients with 
alcoholism (Seo et al., 2013). 
 
Overall purpose:  
The current study will examine the effects of an intervention involving Problem-focused target intervention, 
Stress management, and Breathing modulation (PSB intervention) on improving symptoms of mood and 
addiction related symptoms including mood, craving, and addictive behaviors. The purpose of the 4-week 
intervention is to test the efficacy of the 4-week intervention consisting of 8 sessions for those who are willing 
to invest a month of their time towards improving their symptoms and subsequent follow-up.  
 
The specific aims are as follows: 
 
Aim  (4-week intervention): To examine the effects of the PSB intervention on mood and addiction related 
symptoms (emotional problems, craving,  substance use) in individuals with either risky drinking problems or 
with high stress after the 4-week intervention (8 sessions) of two sessions per week. The effects will be 
examined before and after the 4- week intervention. 

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The effects of the 4-week intervention on daily mood, stress and substance use behaviors will also be 
examined during a 30 -day follow-up. Participants will be followed using a smartphone app to examine the 
effects of the PSB intervention on daily mood, stress and alcohol use behaviors in a real-life setting. And 
participant will receive an online evaluation assessment at the end of the 30-day follow-up period.  
 
2. Probable Duration of Project: State the expected duration of the project, including all follow-up and data 
analysis activities.   
 
Study  (4-week intervention): 2.5 months 
 (2-3 weeks for 4-5 baseline intake sessions; 4 weeks for the telehealth intervention (8 session, twice 
weekly) with daily monitoring and intervention aids for assessing treatment progress via smartphone 
app survey; 1 post assessment; 30 days for daily follow-up via smartphone app; 1 post follow-up 
assessment) 
 
3. Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data. 
 
Habitual alcohol abuse and stress-related mood disturbance are serious problems (Naimi et al., 2003; 
Wechsler et al., 2002). Studies have shown that stress is one of major contributors to mental health disorders 
including emotional disorders (e.g., depression, anxiety) or alcohol abuse problems (e.g., hazardous drinking) 
(Perkins, 1999; Sebena et al., 2012). Despite the significance of stress-related clinical disorders, challenges 
remain in implementing effective prevention and treatment approaches, as those with either high-risk 
drinking or high stress not only disregard their mood and substance-related problems, but also respond 
inadequately to currently available prevention or treatment programs.  
 
It is well documented that stress and alcohol abuse are associated with stress and ANS disruption including 
high stress sensitivity and negative emotion, increased basal heart rate (HR), sustained phasic HR 
acceleration, and reduced heart rate variability (Karpyak, Romanowicz, Schmidt, Lewis, & Bostwick, 2013; 
Sinha et al., 2009; Stormark, Laberg, Nordby, & Hugdahl, 1998; Vaschillo et al., 2008). In those with mood and 
drinking related problems, impaired autonomic regulation characterized by high heart rate and reduced heart 
rate variability (HRV; a primary index of ANS modulation) has been consistently reported (Ingjaldsson, Laberg, 
& Thayer, 2003; Quintana, Guastella, McGregor, Hickie, & Kemp, 2013; Shively et al., 2007; Thayer, Hall, 
Sollers, & Fischer, 2006).  
 
In particular, in times of national crisis, the prevalence of stress- and alcohol- related disorders increases 
substantially. Over the course of the ongoing COVID-19 pandemic, there has been a significance rise in mental 
health symptoms including high levels of emotional distress and alcohol/substance misuse, presenting 
unprecedented public health challenges (Callinan & MacLean, 2020; Rodriguez, Litt, & Stewart, 2020). 
Immediate clinical interventions are exigent to reach out to vulnerable individuals in high-risk areas to 
evaluate and treat those at risk for alcohol- and stress- related disorders.  
 
A strong association between stress and addiction suggests that a strategy to address stress and arousal 
should be included in mood and addiction related treatment or prevention strategies. For example, to relieve 
stress and ANS arousal, a breathing technique has shown to be effective. Studies have found that voluntarily 
regulated breathing practices normalize autonomic activity and improve sympatho-vagal balance, which 
resulted in reduction in psychiatric symptoms including anxiety disorders, trauma- and stressor-related 
disorders, and addiction (Gerbarg & Brown, 2016). Relieving ANS arousal is particularly crucial in preventing 

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alcohol addiction, as an inability to achieving a relaxing state has been associated with high alcohol craving 
and early relapse in AUD patients (Seo et al., 2013). In addition, stress reduction techniques including 
mindfulness have been useful in reducing stress and treating mood and addiction related problems (Kober, 
Brewer, Height, & Sinha, 2017). Taken together, these studies suggest that stress management and a method 
to relieve physiological arousal should be incorporated into prevention and treatment programs for stress 
and addiction related symptoms, emphasizing the need for the PSB intervention described above. 
 
In addition, during the COVID-19, the infectious nature of the pandemic is a significant obstacle to treatment 
efforts. Telehealth interventions have emerged as an ideal tool to overcome this difficulty and treat 
problematic alcohol use by allowing rapid treatment access to those residing in high-risk zones. 
 
To achieve these goals, the current study is intended to examine the efficacy of the PSB intervention on 
addiction symptoms in individuals (age 18-55) with either hazardous drinking or high stress using  4-week  
telehealth intervention as described in the Statement of Purpose. We will utilize an approach that allows a 
concurrent 4-week telehealth intervention using video communications and daily monitoring via a 
smartphone app. 
 
4. Research Plan: Summarize the study design and research procedures using non-technical language that can 
be readily understood by someone outside the discipline. Be sure to distinguish between standard of care vs. 
research procedures when applicable and include any flowcharts of visits specifying their individual times and 
lengths. Describe the setting in which the research will take place. 
 
A total of 100 subjects will be recruited. Heavy drinkers will be defined as those who have risky drinking habits 
at levels to match heavy or binge drinking groups based on the NIAAA clinician guide (2005). COVID-19 
related stress will be identified on the basis of two validated measures including the COVID Stress Scale 
(Taylor et al., 2020) and Perceived Stress Scale (Cohen et al., 1983). All study procedure will be conducted at 
the Yale Stress Center. The PI will work closely with a co-investigator, Dr. Sinha and the YSC clinical team. Dr. 
Sinha is the Chief of Psychology Section in Yale Psychiatry.  
 
In response to the current COVID-19 epidemic, the following study processes will be carried out. To limit 
exposure to COVID-19 and ensure the safety, we will mostly use virtual options, such as video communications 
(zoom, Skype for business, or Microsoft team etc. depending on participants’ convenience), REDCap, or phone. 
An exception will be given to participants who do not have computers or electronic devices; these individuals will 
visit Yale Stress Center for experimental procedure.    
 
For the 4-week intervention, subjects will participate in the 4-week telehealth intervention (8 sessions, twice 
a week) for target intervention and subsequent smartphone app follow-up. During the 4-week period, the 
intervention group will visit Yale Stress Center twice a week for the PSB intervention.  After the intervention, 
all participants will receive post-treatment assessment involving the examination of stress, mood, and alcohol 
use. The project will use prospective monitoring using smartphone app technology in the participants’ natural 
environment during the 30 -days follow-up, during which we will monitor mood, stress, and alcohol intake 
daily.  The intervention will be conducted via telehealth using Yale ITS approved video communications 
technology (e.g., Zoom, Skype for Business, or Microsoft Teams).  After the 4-week intervention, all 
participants will undergo a post-intervention evaluation and followed for 30 days using a smartphone app.  At 
the end of the 30-day survey period, they will have a remote session with a staff for post-study assessments 
and be remotely instructed on how to uninstall the app from their smartphone.  
 
 

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(a) Intake pre-intervention phases   
 
Baseline Assessment (4-week intervention): Following screening using a Qualtrics prescreen survey or via 
phone, eligible subjects will be invited for a video session to obtain an informed eConsent (via REDcap) and an 
initial assessment to further determine eligibility via DSM-5 SCID interview. If the subject meets criteria, he/she 
will be scheduled for baseline sessions (2 hours each) to complete online assessments (via REDCap link) or in-
person video interview. There will be 4-5 intake sessions depending on individual speed. All participants will 
work with specially trained research staff using standardized psychosocial assessments, self-report rating 
forms, and physical health questionnaires via remote sessions.  
 
Assessments 
All participants will be assessed across the following domains using psychometrically established measures. 
The Structured Clinical Interview for DSM-V (SCID-I) will be used to ascertain DSM-5 Axis I and II psychiatric 
and substance abuse diagnoses (First, Williams, Karg, & Spitzer, 2015) and specifically to determine 
presence/absence of DSM-5 alcohol use disorder (AUD). 
The Shipley Institute of Living Scale (SHIPLEY) (Shipley, 1940) has been widely used to assess cognitive 
functioning and impairment. 
 
Assessment for Alcohol use and addiction: 
Family history of alcoholism (FH) will be assessed using the Family Tree Questionnaire (Mann, Sobell, Sobell, & 
Pavan, 1985); (Vogel-Sprott, Chipperfield, & Hart, 1985) which provides a method to obtain drinking status 
and alcohol-related problems for all maternal and paternal first and second degree relatives above the age of 
18. 
The Time-Line Follow-Back Interview will also be used to assess alcohol, other drugs and nicotine use in the 
previous ninety days, during the study and during follow-up. This is a reliable experimenter-administered 
assessment (Sobell & Sobell, 1992), which uses a calendar prompt to facilitate recall of drug use during a 
targeted period, and has been well-validated in alcohol and drug abuse treatment studies (Fals-Stewart, 
O'Farrell, Freitas, McFarlin, & Rutigliano, 2000). 
Smoking History Questionnaire (Brown et al., 2002): A smoking screening questionnaire consisting of items 
about current and past smoking habits will be used to obtain smoking history. 
The Alcohol Use Disorders Identification Test (AUDIT) (Bohn et al., 1995) is a 10-item screening tool 
developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and 
alcohol-related problems. 
The Quantity-Frequency Variability Index (CAHALAN) (Cahalan et al, 1969) measures alcohol consumption 
patterns over a specific time period. 
The Alcohol Urge Questionnaire (AUQ); (Bohn, Krahn, & Staehler, 1995) is a reliable and valid 8-item self-
report craving scale that can be used for repeated assessments. It has been found to be significantly 
associated with drinking measures and dependence severity. 
The Cannabis Use Disorder Identification Test-Revised (CUDIT) will be used to quantify the severity of 
cannabis use over the past six months (S. J. Adamson et al., 2010).  
The Marijuana Motives Questionnaire (MMQ) (Simons et al., 1998) is a self-report questionnaire that will be 
administered at baseline to assess reasons for using marijuana, including coping with stress. 
The Marijuana Craving Questionnaire – Short Form (MjCQ-SF) (Heishman et al., 2009) will be administered 
weekly to assess craving for marijuana along four dimensions: compulsivity, emotionality, expectancy, and 
purposefulness. 
 

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Assessment for Emotional/Behavioral Problems associated with Addiction: The following assessments will be 
administered to assess stress, impulsivity, depression, trauma, and mood symptoms. 
The Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983) is a 14-item self-report assessing the 
degree to which situations are appraised as threatening or demanding. 
The Spielberger State/Trait Anxiety and Anger Questionnaires (Spielberger & . 1970) is a reliable and valid 
measure of both state and trait anxiety and anger. 
The Beck Depression Inventory (Beck, Ward, Mendelson, Mock, & Erbaugh, 1961) is regarded as a well-
established, sensitive self-report measure of depression. 
The Center for Epidemiologic Studies Depression Scale (CES-D) (Lewinsohn et al., 1997) a screening test for 
depression and depressive disorder. 
The Emotion Regulation Scale (ERS, Gratz & Roemer, 2004) a 36-item questionnaire to provide a 
comprehensive measure of the difficulties in emotion regulation. 
The Self-Control Scale -Brief (SCS-Brief) (Tangney, 2004) is a 13-item measure of self-control that measures 
processes that directly involve self-control such as breaking a habit or working toward long-term goals, rather 
than distal behavioral outcomes of self-control. The SCS-Brief will be administered at intake appointments. 
The Barratt Impulsiveness Scale (BIS-11) (Patton et al., 1995) is a questionnaire designed to assess the 
personality/behavioral construct of impulsiveness. 
       The Mindfulness Attention Awareness Scale (MAAS)(Brown & Ryan, 2003) is a 15-item scale designed to  
        assess a receptive state of mindfulness and attention. 
The Perseverative Thinking Questionnaire (Ehring et al., 2011) is a 15-item scale designed to measure the 
broad idea of repetitive negative thought.  Intrusive thoughts are one of the symptoms of trauma. 
The Zimbardo Time Perspective Inventory (ZTPI)(Zimbardo & Boyd, 1999) is a 56-item questionnaire that 
measures individual differences in time-orientation which has been associated with emotional problems. 
The Multidimensional Personality Questionnaire (MPQ)(155 items; Patrick et al., 2002) provides for a 
comprehensive analysis of personality including Positive Emotionality, Negative Emotionality, and Constraint 
which embody affect and temperament constructs. 
The Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994) assesses the severity of pain and its impact on functioning. 
The Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995) measures the tendency to magnify the threat 
value of a pain stimulus and to feel helpless in the presence of pain. 
The Externalizing Spectrum Inventory (Kruger et al., 2007) is 100-item questionnaire that indexes a range of 
correlated problem behaviors and traits in the domain of deficient impulse control such as alcohol or 
substance use problems.  
 The Columbia Suicide Severity Rating Scale (C-SSRS) (Posner et al. 2008) is a survey toolkit to assess severity  
 and intensity of suicidal ideation and behaviors. Suicidality can be one of the symptoms of major depressive  
 disorder. 
The Childhood Trauma Questionnaires (CTQ)  (Bernstein et al., 1997): This is a 28-item test that measures 5 
types of maltreatment-emotional, physical, sexual abuse, and emotional and physical neglect. 
The Chronic Stress Checklist (CSC) adapted from the Cumulative Adversity Interview (adapted from (Turner & 
Lloyd, 2004). This measures chronic stress and adversity.  
The Dutch Eating Behavior Questionnaire (DEBQ) (van Strien, 1986) measures eating styles that may 
contribute to or attenuate the development of obesity, through three scales that measure emotional, 
external and restrained eating. The DEBQ is administered to examine stress-driven eating behaviors 
The Lifestyle and Behavior Survey, adapted from the Cornell Medical Index (Costa & McCrae, 1985; 
Perlmutter & Nyquist, 1990) and the NHANES is administered at intake.  
The Social Media Questionnaire (SMQ) is a 5-item questionnaire given at intake to assess social media use. 
The COPE Inventory (Carver et al., 1989) was developed to assess individuals’ use of different coping 
strategies. The COPE is composed of fifteen subscales. This scale will be administered at intake. 

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The Cornell Medical Index (Abramson, 1966) measures current adverse physical and psychological health 
symptoms. 
 
Additional surveys to assess the COVID-19 related stress 
 
The COVID Stress Scales (CSS) (Taylor et al., 2020) is a 36-item designed to measure COVID-19 stress and 
anxiety symptoms including COVID danger and contamination fears, COVID fears about economic 
consequences, COVID xenophobia, COVID compulsive checking and reassurance seeking and COVID traumatic 
stress symptoms.  
 
The Psychosocial Impact of COVID-19 (PIC) (Chung, 2020) is a 2-item assessing the level of difficulties and 
distress in people’s lives over the past two weeks.   
 
The Psychological Stress Associated with the COVID-19 Crisis questionnaire (PSACC) (M. Adamson, 2020) is a 
37-item designed to measure the level of stress during the COVID-19 pandemic and characterize it according 
to location, gender, income, and other factor.  
 
The UCLA Loneliness Scale (Version3) (Russell, 1996) is a 20-item measure that assesses how often a person 
feels disconnected from others.  
 
The Interpersonal Support Evaluation List (ISEL) (Russell, 1996) is designed to measure perceptions of social 
support among individuals in the general population.  
 
The COVID-19 Community Response Survey-Social Distancing Impacts (JHU-SDI) (Johns-Hopkins, 2020a) is 
designed to measure the impact of COVID-19 on people’s lives due to a precautionary measure of social 
distancing.  
  
The COVID-19 Community Response Survey-Substance Use (JHU-SU) (Johns-Hopkins, 2020b) is a 15-item 
designed to assess the use of substance after and during the COVID-19 pandemic.  
 
 
(b) Target Intervention Combined with Breathing and Stress Management (PSB) 
Subsequently, after the completion of the baseline assessment, all subjects will remotely participate in a 4-
week digital intervention via video communications using platforms approved by Yale University IT services 
such as Zoom, Skype for Business, or Microsoft Teams. For 4 weeks, participants will attend 1.5 to 2 hours 
individual therapy sessions (8 sessions in total, twice a week) with Dr. Seo and her clinical team for prevention 
for alcohol use disorder using video communications. They will also be asked to use a smartphone app daily to 
assess treatment progress and learn coping skills (e.g., homework). At the end of the 4-week digital 
intervention, there will be post-treatment evaluations.  Some components of the PSB intervention include:  
(1) Problem-focused target intervention partially adapted from cognitive behavioral therapy and NIAAA-  
approved coping skills training strategies (Kadden et al., 2003).   
(2) Breathing modulation to normalize ANS function including techniques partially adapted from resonance 
breathing (e.g, the Breath-Body-Mind (BBM) technique (Brown & Gerbarg, 2012)). 
The content involves increasing knowledge on stress reactivity, emotional problems, and drinking habits, 
cultivating breathing and emotion and stress regulation strategies, including  self-regulated breathing. Each 
session involves self-monitoring of current stressors and challenges to handling stressors (communication, 
emotional reactivity, drinking, substance use) and applying strategies of awareness, reflecting, goal setting as 
well as integrating healthy lifestyle and choices. 

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(c) Follow-up: real-world smartphone app  
The method of daily monitoring has an advantage over traditional follow-up measures by overcoming 
recall bias and providing more accurate, real-time behavioral data in natural settings (Shiffman, Stone, & 
Hufford, 2008). This approach has been well supported in studies examining daily mood, stress and 
substance-use patterns (Runyan et al., 2013; Wray, Merrill, & Monti, 2014). We will provide smartphones to 
those who do not have. If it is lost or broken, we will provide another one. The app will only be shown to 
participants who will register the study. The app does not require a password to access once they register. 
However, no response will be stored in the phone, and all the data will be coded and transferred 
immediately. The MetricWire app is not commercial and research only app. This app is HIPPA compliant and 
passed Yale IRB and IT review previously.  
 
The MetricWire app has previously been used in clinical research and is HIPAA compliant. All participants 
will complete a daily questionnaire during  the study in the evening. Before the smartphone app phase, 
subjects will initially complete a face-to-face 15–20-minute training session where a research assistant will 
assist in installing an app on their smartphone devices which they will use to report their daily experiences. 
They will be given instructions on how to operate the smartphone app and a guide that they may take home 
with them that will outline the information covered in the training session. They will also be given contact 
information, should they have any problems or questions with the smartphone app over the course of the 
study. It will be explained that all data on the app is encrypted, and that the data is sent to a secure server 
where data is identified by subject ID only. Subjects will also be informed that we will be monitoring the 
upload of data from the smartphone app to the secure server to verify that everything is working correctly. 
Upon the completion of all study procedure, all participants will be debriefed about the study.  
 
Data Management and Processing: 
 
Data Management:  Research data is collected using Yale University’s REDCap system. REDCap is a secure 
HIPAA compliant web application for building and managing online surveys and databases, supported, and 
approved by Yale ITS. Research data is exported and stored on a secure shared virtual drive maintained by 
Yale ITS. 
 
All subjective data are kept in locked cabinets at the Yale Stress Center (YSC), New Haven and are identified 
only by study ID.  Data are de-identified and stored on the workstations at the Yale Stress Center, which are 
highly secure and HIPPA compliant. Access to YSC workstations is password-restricted and is only available to 
Dr. Seo and her research staff. All research data is kept in two places--one as a hardcopy in a locked file with 
records identified only by the participants’ study number and the second in computerized databases 
protected by two-level password systems that are managed by Yale ITS. Upon completion of the study, all 
hardcopies will be destroyed. The only documents linking participants’ names to their study numbers will be 
the consent forms. These will be stored in a separate locked file cabinet and may only be accessed by Dr. Seo 
(PI) and relevant study staff. 
 
Safety planning in response to the COVID-19 epidemic 
 
To limit exposure to COVID-19, one-on-one in-person meetings should be avoided as much as possible.  
Most of procedure will be conducted remotely. However, if one-on-one meetings must be held in person, the 
following guidelines will be carried out.  
 

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Before any study visits, research participants will be screened for COVID-19 symptoms by filling out the COVID-
19 questionnaires prior to the study visit at Yale Stress Center (YSC) and at the time of the on-site study visit.  
 
Participant will be asked to fill out YSC safety questionnaire for YSC visits. If study participants say “yes” to any 
of the COVID-19 related questions, their appointment will be moved to a later date, and they will be directed 
to the YNHH COVID-19 Support Call Center (203-688-1700 option 1). 
 
The study site will be disinfected before and after each study visit based on CDC guideline. The measurements 
of temperature and oxygen saturation levels of research staff will be taken for both research personnel and 
study participants with a non-contact forehead thermometer and a pulse oximeter.  If temperature is greater 
than 99.5 degrees Fahrenheit in subject, the research subjects and study staff will be asked to leave and seek 
medical attention. If oxygen saturation is below 95% in subject or research staff, participants will not be allowed 
to participate in research appointment, and research staff will be asked to leave and seek medical attention. 
 
During in-person visits, both participants and research staff should maintain the required distancing (6 feet) 
and wear a mask.  Anybody entering the study site should properly wash their hands with alcohol-based hand 
sanitizer (containing at least 60% alcohol) or soap and water in protecting against the spread of germs and 
viruses. In case participants do not have proper masks to wear, a mask and glove will be provided on-site study 
visits.  
 
 
5. Genetic Testing    
N/A ☒ 
A. Describe 
i. 
the types of future research to be conducted using the materials, specifying if immortalization of 
cell lines, whole exome or genome sequencing, genome wide association studies, or animal 
studies are planned Write here 
ii. the plan for the collection of material or the conditions under which material will be received 
Write here 
iii. the types of information about the donor/individual contributors that will be entered into a 
database Write here 
iv. the methods to uphold confidentiality Write here 
 
B. What are the conditions or procedures for sharing of materials and/or distributing for future research 
projects? Write here 
C. Is widespread sharing of materials planned? Write here 
D. When and under what conditions will materials be stripped of all identifiers? Write here 
E. Can donor-subjects withdraw their materials at any time, and/or withdraw the identifiers that connect 
them to their materials?  Write here 
i. 
How will requests to withdraw materials be handled (e.g., material no longer identified: that is, 
anonymized) or material destroyed)? Write here 
F. Describe the provisions for protection of participant privacy Write here 
G. Describe the methods for the security of storage and sharing of materials  Write here 
 
6. Subject Population: heavy/binge drinkers  
 
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 

Page 9 of 23 
 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement. 
 
☐Children 
 
 
☒ Healthy  
 
 
☐Fetal material, placenta, or dead fetus 
☐Non-English Speaking  
☐ Prisoners 
 
 
☐Economically disadvantaged persons 
☐Decisionally Impaired  
☐ Employees 
 
 
☐Pregnant women and/or fetuses 
☐Yale Students  
 
☐ Females of childbearing potential 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects? 
Yes ☐  No ☒  
 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion? 
 
Inclusion Criteria:  
(1) Aged 18-55 years;  
(2) Ability to read and write English;  
(3) Heavy/Binge Drinkers: Drinking at levels to match heavy or binge drinking groups (NIAAA Clinician Guide, 
2005):  Heavy Drinkers (HD): Regular alcohol use over the past year of, at least 8 standard drinks/wk for 
women and at least 15 drinks/wk for men. Binge Drinkers (BD): Binge drinking patterns (Women: 4 or more 
drinks; men: 5 or more drinks in one setting).  
(4) COVID-19 related stress will be identified on the basis of two validated measures including the COVID Stress 
Scale (Taylor et al., 2020) and Perceived Stress Scale.(Cohen et al., 1983). The PSS is a widely used measure of 
stress that provides standardized cut scores.  
  
Exclusion Criteria:  
(1) Meet current or past DSM-V criteria for Axis I psychiatric disorders including any substance use disorders 
except for mild alcohol use disorder (AUD), marijuana use disorder, tobacco use disorder, and opioid use 
disorder.   
(The current study targets alcoholism prevention in risky drinkers, and thus excludes those who already 
have moderate and severe AUD. However, many risky drinkers often have mild AUD, thus we include this. 
In addition, marijuana, tobacco, and opioid use disorders are included, given the high comorbidity found 
between marijuana/opioid use and heavy drinking in general population.) 
(2) Any significant current medical conditions;  
(3) Women: peri- and post-menopausal or pregnant women due to hormonal interactions with stress 
response;  
(4) Current use of psychotropic and other medications or illicit drugs. 
 
9. How will eligibility be determined, and by whom? Write here 
Research staff will determine eligibility. Potential subjects will complete an initial telephone screening and 
then will be scheduled to meet using video communications with research staff to complete an intake 
appointment at the Yale Stress Center. Research staff will review the medical history of the participant to 
ensure all inclusion and exclusion criteria are met, under the supervision of Dr. Seo. 
 
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research.  
 
The potential risks to the subjects in the proposed study are listed below.  

Page 10 of 23 
 
 
Behavioral assessments, questionnaires, and surveys are all noninvasive and should add no risk.  The major 
disadvantages are the time taken to complete them, and possible breach of confidentiality.   
Past experience with these measures indicates that they are acceptable to subjects. Careful efforts aimed at 
maintaining confidentiality have been effective in previous research, and only patients’ code numbers will be 
recorded on the forms themselves to protect confidentiality. If the subject reports discomfort completing the 
questionnaires or the visual stimuli task, they are free to drop out at any time without penalty. Any subject that 
reports emotional discomfort during or after the completion of questionnaires will receive an individual counseling 
session by a trained clinical staff who is experienced in therapy. The screening of subjects using the inclusion and 
exclusion criteria, and the comprehensive physical and psychiatric evaluation will minimize the risk of including 
subjects who are otherwise inappropriate.  
 
PSB Intervention  
Participation in the study in completely voluntary. If a participant feels uncomfortable at any time during the 
intervention, counseling can be provided to address these concerns. Outpatient subjects are free to choose not to 
take part in this study and stop disclosing their health information at any time.  
 
Smartphone app survey:  
Subjects will respond to smartphone surveys as they go about their daily lives, which may occur in the presence of 
others. However, smartphones are widely used in public for many tasks by people in everyday life and the 
completion of the surveys will be brief and relatively discrete. Responses gathered on the smartphones will be 
encrypted and sent to a secure server. Confidentiality will be maintained to the degree permitted by the 
technology used. Data will be connected with subject ID only. The MetricWire smartphone app has been designed 
to be compliant with HIPAA regulations. This app is not commercial and research only app and passed Yale IRB 
and IT review previously. The app encrypts data on participants’ phones and while data is wirelessly transferred. 
The app randomly generates a 24-digit identification code that contains numbers and letters and remains 
consistent for each subject throughout the smartphone assessment phase. This identification code will be linked 
by the research team with the numerical Subject ID that is assigned to subjects upon their initial laboratory visit. 
The data is monitored daily, and if any duplicate data or suspicious activity or pattern is detected in the 
participant’s data, the research team will immediately contact the participant to ensure if a problem or issue has 
occurred. Also, all smartphones are required to be password protected in order to restrict access to the app other 
than the participants.   
 
Confidentiality:  
All data will be kept confidential except in cases of imminent danger to the participants. Such limits to 
confidentiality will be clearly explained to participants verbally and in the written consent forms. Confidentiality 
regarding collected materials will be maintained via a numbered reference system maintained by the investigators. 
Subjects' names will appear only on a consent form and a "key" form kept by the PI in locked filing cabinets. Only the 
PI (Dr. Seo), Dr. Sinha (co-investigator) and relevant research staff will have access to any forms specifying both 
participant name and subject number.  All number-coded subjective data will be kept in locked offices with access 
only to investigators and research staff.  In case we obtain eConsent, the completed PDFs will be downloaded and 
stored in a study folder that can only be accessed with a unique password in a 3-lock Yale ITS managed storage. The e-
consent also records the IP address of the participant and displays this information in the file repository in order to 
help regulate potential duplicate forms from a single IP address. Furthermore, good clinical and research practice 
procedures and HIPAA regulations will be followed. 
 
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
See above 

Page 11 of 23 
 
12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.) 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? minimal 
b. 
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? N/A 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for 
i. Minimal risk 
ii. Greater than minimal 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: 
i. How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? Write here 
ii. What provisions are in place for management of interim results? Write here 
iii. What will the multi-site process be for protocol modifications? Write here 
 
Minimal Risk DSMP 
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and conducting 
the safety reviews quarterly. During the review process the principal investigator will evaluate whether the study 
should continue unchanged, require modification/amendment, or close to enrollment. The principal investigator 
and the Institutional Review Board (IRB) have the authority to stop or suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to Subjects or 
Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event that such events occur, 
Reportable Events (which are events that are serious or life-threatening and unanticipated (or anticipated but 
occurring with a greater frequency than expected) and possibly, probably, or definitely related) or Unanticipated 
Problems Involving Risks to Subjects or Others that may require a temporary or permanent interruption of study 
activities will be reported immediately (if possible), followed by a written report within 5 calendar days of the 
Principal Investigator becoming aware of the event to the IRB (using the appropriate forms from the website) and 
any appropriate funding and regulatory agencies. The investigator will apprise fellow investigators and study 
personnel of all UPIRSOs and adverse events that occur during the conduct of this research project through weekly 
study meetings, and via email as they are reviewed by the principal investigator. The protocol’s funding agency, 
National Institute on Alcohol Abuse and Alcoholism (NIAAA), and Yale Faculty Account, will be informed of 
Reportable Events adverse events within 5 days of the event becoming known to the principal investigator. 
 
13. Statistical Considerations: Describe the statistical analyses that support the study design.  
 
Baseline screening, intake, self-report, and interview data will be collected using the web-based REDCap system 
that is fully supported by Yale and set up and well established at the Yale Stress Center. All rating data will be 
double-entered for verification. Quality control measures for out-of-range values and error checking programs are 
well established and will be implemented. 

Page 12 of 23 
 
To test the efficacy of the PSB intervention in reducing stress, alcohol craving and use, all analyses will be 
conducted using the intent-to-treat sample and each hypothesis will be tested using General Linear models 
(GLMs) (Diggle, Heagerty, Liang, & Zeger, 2002) examining the main effects of Time (pre-/post-/Follow-up).  
 
For smartphone data, alcohol use outcomes obtained from mobile app will be defined in both dichotomous and 
continuous manner (e.g., time to first drink or time to heavy drinking after the prevention; percent days 
abstinence and heavy drinking days (men: 5 or more; women: 4 or more) as continuous measures). Frequency, 
the total number of days of stress or alcohol use; and quantity, the average amount of alcohol use (number of 
drinks) or average levels of stress per occasion will also be computed. Multiple regression and mixed effects 
regression models (MRMs) will be used to evaluate the effects of prevention on prospective repeated 
assessments of stress, emotion, alcohol use, craving, and mood related data. Specific MRMs will model within 
person time varying and invariant data from daily stress and substance use patterns to assess group differences 
and examine whether behavioral changes after prevention predicts future stress and alcohol-related behaviors.  
 
SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES 
 
 
If this section (or one of its parts, A or B) is not applicable, check off N/A and delete the rest of the section. 
 
A.  RADIOTRACERS 
☒N/A 
 
 
B.  DRUGS/BIOLOGICS    ☒N/A 
 
 
 B.  DEVICES 
 ☒N/A 
 
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. Targeted Enrollment: Give the number of subjects:  
a. Targeted for enrollment at Yale for this protocol: 100 
b. If this is a multi-site study, give the total number of subjects targeted across all sites: n/a 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
☒ Flyers 
☐ Internet/web postings 
☐ Radio 
☐ Posters 
☐ Mass email solicitation 
☐ Telephone 
☐ Letter 
☐ Departmental/Center website 
☐ Television 
☐ Medical record review*  
☐ Departmental/Center research boards 
☐ Newspaper 
☐ Departmental/Center newsletters 
☒ Web-based clinical trial registries 
☐ Clinicaltrails.gov  
☒ YCCI Recruitment database 
☐ Social Media (Twitter/Facebook):  
 
☐ Other:  
 
 
 
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx 
 
3.  Recruitment Procedures:  
a. Describe how potential subjects will be identified. Write here 

Page 13 of 23 
 
 
Subjects will be recruited through flyers posted in the community, and advertisements on social media/internet sites. 
Potential subjects will complete an initial telephone screening or be asked to complete a Qualtrics prescreening 
survey and then will be scheduled to meet with research staff to complete an intake appointment at the Yale 
Stress Center. 
 
For the COVID study, participants with COVID-19 stress, Participants will also be recruited from the regions that 
are most significantly affected by COVID-19 in the US (based on the Center for Disease Control and Prevention 
(CDC), www.cdc.gov) in addition to Connecticut area by placing targeted advertisements on social networking 
outlets (e.g., Craigslist, Facebook, and Twitter) or other local platforms. 
  
b. Recruitment of participants  will also be conducted through a dedicated Yale Stress Center (YSC) Recruitment 
Channel specializing in coordinating centralized recruitment of participants into center studies. This 
recruitment team that has a well-developed treatment referral network comprising a variety of treatment, 
social service and addiction referral sources in the Greater New Haven area.  
 
The YSC Recruitment Team provides coordinated centralized recruitment of participants into YSC affiliated 
studies typically through the placement of weekly advertisements in area newspapers, posting flyers in local 
areas. In addition, referrals from the Yale Substance Abuse Treatment facilities will also be a source of 
patients for study participation. Staff at these facilities will be given flyers detailing the study and encouraged 
to have their clients contact us for screening. This approach has allowed us to recruit subjects from a variety 
of race and socioeconomic backgrounds. Describe how potential subjects are contacted.  
 
Potential subjects will contact us via our toll-free phone number, which can be obtained from the study 
advertisements on social media/internet sites, or flyers posted in the community, and be screened by 
research staff. 
 
c. Who is recruiting potential subjects?  Research staff at the Yale Stress Center 
 
 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject?  
☐Yes, all subjects 
☐Yes, some of the subjects 
☒No 
 
If yes, describe the nature of this relationship. Write here 
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.) 
Choose one:  
☐ For entire study  
☒ For recruitment/screening purposes only  
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated HIPAA 
research authorization form available on the University’s HIPAA website at hipaa.yale.edu. 
 

Page 14 of 23 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data:  
 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data:  
 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer. 
 
6. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making.  
 
Following the initial telephone screening, eligible participants will meet with a research assistant to obtain 
informed consent. The consent process can be done either in person or remotely via a REDCap eConsent if 
needed. The following procedure will be implemented for the eConsent procedure. 
 
First, the potential participants will receive a secure REDCap link to view the consent form and have a remote 
session with research staff. After reviewing the consent form, they will go over the study procedure and all 
aspects of the consent form with staff and have enough time for study Q & A and the risk involved before 
making decisions. If they agree to participate, they will be asked to sign their name using a mouse on an 
eConsent form. Then, they will select “Next Page” at the bottom and a read only copy of the consent will be 
generated that they can review, download, and/or print. Also, at the bottom of the page they will view “I 
certify that all the information in the document above is correct, and I understand that signing this form 
electronically is the equivalent of signing a physical document.” Once this is selected, they will be able to 
submit the consent from. The completed PDFs will be downloaded and stored in a study folder that can only 
be accessed with a unique password in a 3-lock Yale ITS managed storage. The e-consent also records the IP 
address of the participant and displays this information in the file repository in order to help regulate 
potential duplicate forms from a single IP address.  
 
7. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed.  
 
After the participant has read over the consent form, research staff will further explain the study, including 
the risks involved. Research staff will ask the potential subject how well they understood the consent, and 
answer questions they may have. 
 
8. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use.  
 

Page 15 of 23 
 
Non-English speaking individuals will not be recruited for this study. 
 
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒ 
 
Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled. 
 
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website. 
 
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above.  
 
9. 
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.   
 
☐Not Requesting any consent waivers  
 
☒Requesting a waiver of signed consent: 
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) telephone screen 
☐ Entire Study (Note that an information sheet may be required.) 
 
 
  
  ☐ Requesting a waiver of consent: 
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) 
☐ Entire Study   
 
 For a waiver of signed consent, address the following: 
• Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO ☒  
• Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☒ 
  
 OR 
• Does the research pose greater than minimal risk? YES ☐    NO☒  
• Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☒ 

Page 16 of 23 
 
 
 
 
 
 
 
 
 
 
SECTION IV: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
1. What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?    
Results of the  psychological assessments, self-reports, and data collected during pre-intervention, post-
intervention, and interventions, will be collected and used for research. The proposed study will be conducted by 
specialized and trained research staff using standardized and psychosocial assessments. Data collected and 
analyzed in the study will be derived from two main sources: semi-structured clinical interviews and self-rating 
scales: psychiatric history, medical history, demographic self-reports of age, race, socioeconomic status, marital 
status, educational and occupational levels.  
 
2. How will the research data be collected, recorded and stored?      
 
Research data will be collected on paper assessments and using Yale University’s REDCap system.  All research 
data is stored in two places--one as a hardcopy in a locked file, with records identified only by the participant’s 
study number, and the second in computerized databases protected by two-level password systems on Yale 
encrypted desktop computers. 
 
3. How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard Drive   ☒Secured Server  
☐Laptop Computer  ☒Desktop Computer  ☐Other 
 
4. What methods and procedures will be used to safeguard the confidentiality and security of the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study?    
 
Upon enrollment, all study subjects will be assigned a unique study number. The study number—and no 
personal identifiers—will be used as labels for study records, samples and any other related research 
documentation. All electronic and digital files will be stored on the secure Yale network, and the PC accessing 
the network will be password protected and encrypted. All paper files, such as consent forms, will be stored in 
a locked file cabinet in a locked office and access is limited to members of the study research team. 
 
For a full waiver of consent, please address all of the following: 
• 
Does the research pose greater than minimal risk to subjects?   
☐ Yes If you answered yes, stop. A waiver cannot be granted.   
☐ No 
• 
Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐ 
• 
Why would the research be impracticable to conduct without the waiver? Write here 
• 
Where appropriate, how will pertinent information be returned to, or shared with subjects at a later date? 
Write here 

Page 17 of 23 
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu 
 
5. What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured.  
 
Upon completion of study and data analysis, a professional information protection, storage, and disposal 
company will be retained to dispose of research files and informed consent documentation. 
 
6. If appropriate, has a Certificate of Confidentiality been obtained?  Yes, we obtained CoC. 
 
SECTION V: POTENTIAL BENEFITS 
 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.)  
 
There are some potential benefits of the proposed study. First, monitoring drinking, learning stress reduction and 
breathing modulation may be helpful to some subjects. Second, this study will evaluate the PSB as a potential 
alcoholism prevention program. If the efficacy of the PSB intervention is supported, our findings will identify an 
effective prevention strategy that can be delivered in the participants’ community. Given these valuable benefits 
to the subjects and their community and the minimal risks of the study procedures, we believe that the study risks 
are reasonable in relation to the potential benefits. 
 
Also, stress reduction and breathing methods may help participants self-regulate distress and emotion without 
over-reactivity. Thus, these skills may then allow participants to be particularly effective in implementing 
knowledge about regulating craving and drinking urge and to adopt healthier choices and habits. 
 
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1. Alternatives: What other alternatives are available to the study subjects outside of the research?  
Subjects need not participate in this study to receive stress management or breathing training or substance 
use counseling. 
 
Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation. 
 
For the 4-week intervention:  participants will be compensated for their time taken for a series of study 
appointments and participations over the course of 2.5 months of the study period. The total amount that 
each participant may receive is up to $778 per participant for completing all aspects of the study (baseline 
assessments, 4-week digital interventions, 28-day daily monitoring, and a follow-up evaluation at the end of 
30 days). 
 
 

Page 18 of 23 
 
Baseline Assessments: Participants in the assessment and intervention groups will be paid up to $100 for 
screening, DSM-5 diagnosis, & 4-5 online baseline assessments ($20 per session).  
 
4-week Period:  
 Intervention  group 
Participant will receive up to $488 for completing the study procedure related to 4-week intervention for 
treatment sessions, smartphone app surveys and post-treatment evaluation. 
 
Sessions: Participants will receive up to $200 including $20 for per session (two sessions weekly; 8 sessions in 
total (8 x $20 = $160) and bonus. An additional $20 bonus will be rewarded for the completion of all 4 
sessions every 2 weeks of treatment during the 4-week treatment period. 
 
Smartphone surveys: They will also receive up to $248 for the completion of a 28-day daily smartphone app 
surveys including $3 for each daily intervention exercise (28 x $3 = $84), smartphone monitoring survey (28 x 
$3 = $84), and weekly bonus. They will receive an additional weekly bonus of $20 for completing 100% (14/14 
surveys; submitted a total number of two surveys (daily evening surveys + daily intervention exercise) per 
week), $18 for completing at least 92.5% (13/14 surveys;  submitted a total number of two surveys (daily 
evening surveys + daily intervention exercise) per week) or $16 for completing at least 86% (12/14 surveys; 
submitted a total number of two surveys (daily evening surveys + daily intervention exercise) per week) of the 
surveys in each week. Both the daily evening survey and daily intervention exercise must be completed for a 
day to count towards the weekly bonus.  
 
At the end of treatment, they will also receive $40 for a post assessment at the end of 4-week intervention.    
 
Follow-up evaluations: Participant will be compensated for their time up to $190 for 30-days follow-up after 
treatment. For daily monitoring follow-up assessments, they will be paid $3 for daily survey over 30 days (30 x $3 
= $90). They will also receive additional $20 biweekly bonus for completing at least 100% (14 out of 14 surveys), 
$15 for 90% (13 out of 14 surveys), and $10 for 80% (12 out of 14 surveys) of every 14-day survey. Additionally, 
they will also receive $60 for a video session and completing online evaluation assessments at the end of the 30-
day follow-up period.  
 
Therefore, the total that the intervention group may be reimbursed for their time if they complete the study, 
attend all 8 treatment sessions and a 100% completion rate for the smartphone surveys, is $778.  
 
2. Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects.  
 
All parts of the research process will be provided at no cost to the subjects. 
 
3. In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws). 
 
While medical therapy will be offered for any physical injuries sustained as a consequence of participation in this 
research, the subject and their insurance carrier will be responsible for the cost of such treatment. Financial 
compensation for injury is not available.   
 

Page 19 of 23 
 
a. Will medical treatment be available if research-related injury occurs? Medical therapy will be 
offered for any physical injuries sustained as a consequence of participation in this research. 
b. Where and from whom may treatment be obtained? Any licensed facility / practitioner 
c. Are there any limits to the treatment being provided? No 
d. Who will pay for this treatment? The subject and their insurance carrier will be responsible for 
the cost of treatment. Financial compensation for injury is not available. 
e. How will the medical treatment be accessed by subjects? Subjects will be encouraged to receive 
services through practitioners in any licensed facility where their insurance company may cover 
their medical expenses.  
 
 
IMPORTANT REMINDERS 
 
Will this study have a billable service?  Yes ☐  
 No☒ 
 
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects.  
 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu 
 
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☒  
 
If Yes, please answer questions a through c and note instructions below.   
a. Does your YNHH privilege delineation currently include the specific procedure that you will perform? Yes ☐  No 
☐ 
b. Will you be using any new equipment or equipment that you have not used in the past for this procedure? Yes 
☐  No ☐ 
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐ 
  
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department of 
Physician Services (688-2615) for prior approval before commencing with your research protocol. 
 
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH  
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 

Page 20 of 23 
 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH. 
 
 
 
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