Perinatal Attentional Retraining Intervention for Smoking (PARIS) for Minority Women
Phase: NA
Conditions: Postpartum Smoking Relapse
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023
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YALE UNIVERSITY
HUMAN INVESTIGATION COMMITTEE
Application to Involve Human Subjects in Biomedical Research
100 FR1
HIC OFFICE USE
ONLY
Please refer to the HIC website for application instructions and 
information required to complete this application. The 
Instructions are available at http://www.yale.edu/hrpp/forms- 
templates/index.html.
Submit the original application and two (2) copies of all 
materials including relevant sections of the grant which 
funds this project (if applicable) to the HIC.
DATE
STAMPED-
RECEIVED
PROTOCOL NUMBER
1008007245
Title of Research Project:
Ecological Momentary Assessment and Attentional Retraining for Postpartum Smoking Relapse: A Pilot Study
Principal Investigator: Ariadna Forray, MD
Yale Academic Appointment: Associate Professor
Campus Address: 40 Temple Street, Suite 6B, New Haven, CT 06510
Campus Phone: 764-8620
Fax:
Pager:
E-mail: ariadna.forray@yale.edu
Protocol Correspondent Name & Address (if different than PI):
Campus Phone:
Fax:
E-mail:
Faculty Advisor:(required if PI is a student, 
resident, fellow or other trainee)
NA
Yale Academic Appointment:
Campus Address:
Campus Phone:
Fax:
Pager:
E-mail:
Does the principal investigator, co-investigator, or any research team member obtaining consent, or any of 
their family members (spouse, child, domestic partner) have an incentive or interest, financial or otherwise, 
that may be viewed as affecting the protection of the human subjects involved in this project, the scientific 
objectivity of the research or its integrity? See Disclosures and Management of Personal Interests in Human 
Research http://www.yale.edu/hrpp/policies/index.html#COI
□Yes
x No
If yes, list names of the investigator or person obtaining consent:
SECTION I: ADMINISTRATIVE INFORMATION
APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023
 NCT04114877 

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1. Performing Organizations: Identify the hospital, in-patient or outpatient facility, school or
other agency that will serve as the location of the research. Choose all that apply:
a. Internal Location[s] of the Study:
Magnetic Resonance Research Center
PET Center
(MR-TAC)
YCCI/Church Street Research Unit (CSRU)
Yale Cancer Center
YCCI/Hospital Research Unit (HRU)
Yale-New Haven Hospital
YCCI/Keck Laboratories
Specify Other Yale Location:
Cancer Data Repository/Tumor Registry 
PMS and Perinatal Psychiatric Research Program
b. External Location[s]:
APT Foundation, Inc.
Haskins Laboratories 
Connecticut Mental Health Center
John B. Pierce Laboratory, Inc. 
Veterans Affairs Hospital, West Haven
Other Locations, Specify:
c. Additional Required Documents (check all that apply):
N/A
*YCCI-Scientific and Safety Committee (YCCI-SSC)
Approval Date:
*Pediatric Protocol Review Committee (PPRC)
Approval Date:
*YCC Protocol Review Committee (YRC-PRC)
Approval Date:
*Dept. of Veterans Affairs, West Haven VA HSS
Approval Date:
*Radioactive Drug Research Committee (RDRC)
Approval Date: 
YNHH-Radiation Safety Committee (YNHH-RSC)
Approval Date: 
Magnetic Resonance Research Center PRC (MRRC-PRC) Approval Date: 
YSM/YNHH Cancer Data Repository (CaDR)
Approval Date: 
Dept. of Lab Medicine request for services or specimens form
*Approval from these committees is required before final HIC approval is granted. See instructions
for documents required for initial submission and approval of the protocol. Allow sufficient time for
these requests. Check with the oversight body for their time requirements.
2. Probable Duration of Project: State the expected duration of the project, including all
follow-up and data analysis activities. 8/1/2010 – 7/31/2016; second wave with
additional funding 10/1/2018-6/30/2022 (no cost extension)
3. Targeted Enrollment: What is the number of subjects
a.
targeted for enrollment at Yale for this protocol? 30 (original), an additional 50 in second
wave
If this is a multi-site study, what is the total number of subjects targeted across all sites?
b. expected to sign the consent form? 30 (original), an additional 65 in second wave
c. expected to complete some or all interventions for this protocol? 30 (original), an additional 50 in
second wave
4. Research Type/Phase: (Check all that apply)
a. Study Type
Single Center Study 
Multi-Center Study
Does the Yale PI serve as the PI of the multi-site study? Yes
No
SECTION II: GENERAL INFORMATION
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Coordinating Center/Data Management 
Other:
b. Study Phase
Pilot
Other (Specify)
N/A
Phase I
Phase II
Phase III
Phase IV
c. Area of Research: (Check all that apply) Note that these are overlapping definitions and more 
than one category may apply to your research protocol. Definitions for the following can be found 
in the instructions section 4c:
Clinical Research: Patient-Oriented
Clinical Research: Outcomes and 
Clinical Research: Epidemiologic and Behavioral
Health Services
Translational Research #1 (“Bench-to-Bedside”)
Interdisciplinary Research 
Translational Research #2 (“Bedside-to-Community”)
Community-Based Research
5. Is this study required to be registered in a public database? Yes
No 
If yes, where is it registered?
Clinical Trials.gov registry 
Other (Specify)
6. Will this research study utilize clinical care services at Yale New Haven Hospital or YMG? 
Yes 
 No
If yes, might these be billable to the subject, the sponsor, grant or other third party payer? 
Yes
No 
If you answered "yes", please register this study in the IDX/GE system at
http://ycci.yale.edu/comply/billing_idxge.html
7. Are there any procedures involved in this protocol that will be performed at YNHH or one of 
its affiliated entities? Yes _X 
No 
If Yes, please answer questions a through c and note 
instructions below. If No, proceed to Section III.
a. Does your YNHH privilege delineation currently include the specific procedure that you will 
perform? Yes
b. Will you be using any new equipment or equipment that you have not used in the past for 
this procedure? No
c. Will a novel approach using existing equipment be applied? No
If you answered “no” to question 7a, or "yes" to question 7b or c, please contact the YNHH 
Department of Physician Services (688-2615) for prior approval before commencing with your 
research protocol.
Funding Source: Please see IRES-IRB.
1. Research Team: Please see IRES-IRB
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING
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APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023
APPROVED BY THE YALE UNIVERSITY IRB 8/2/2019
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NOTE: The HIC will remove from the protocol any personnel who have not completed required training. 
A personnel protocol amendment will need to be submitted when training is completed.
As the principal investigator of this research project, I certify that:

The information provided in this application is complete and accurate.

I assume full responsibility for the protection of human subjects and the proper conduct of the 
research.

Subject safety will be of paramount concern, and every effort will be made to protect subjects’ 
rights and welfare.

The research will be performed according to ethical principles and in compliance with all federal, 
state and local laws, as well as institutional regulations and policies regarding the protection of 
human subjects.

All members of the research team will be kept apprised of research goals.

I will obtain approval for this research study and any subsequent revisions prior to my initiating the 
study or any change and I will obtain continuing approval of this study prior to the expiration date 
of any approval period.

I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to 
participants.

I am in compliance with the requirements set by the University and qualify to serve as the 
principal investigator of this project or have acquired the appropriate approval from the 
Dean’s Office or Office of the Provost, or the Human Subject Protection Administrator at 
Yale-New Haven Hospital, or have a faculty advisor.

I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities.
 
8/10/10
PI Name (PRINT) and Signature
Date
SECTION IV:
PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR 
AGREEMENT
Date
Advisor Name (PRINT) and Signature
As the faculty advisor of this research project, I certify that:

The information provided in this application is complete and accurate.

This project has scientific value and merit and that the student or trainee investigator has the necessary 
resources to complete the project and achieve the aims.

I will train the student investigator in matters of appropriate research compliance, protection of human subjects 
and proper conduct of research.

The research will be performed according to ethical principles and in compliance with all federal, state and 
local laws, as well as institutional regulations and policies regarding the protection of human subjects.

The student investigator will obtain approval for this research study and any subsequent revisions.
Prior to initiating the study or revision and will obtain continuing approval prior to the expiration of any 
approval period.

The student investigator will report to the HIC any serious injuries and/or other unanticipated problems 
involving risk to participants.

I am in compliance with the requirements set forth by the University and qualify to serve as the faculty advisor 
of this project.
APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023

APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023
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Department Chair’s Assurance Statement
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project?
Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
No
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project?
Yes, and I agree to submit the Protocol-Specific Conflict of Interest Disclosure Form. 
No
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately.
Chair Name (PRINT) and Signature
Date
Department
YNHH Human Subjects Protection Administrator Assurance Statement
Required when the study is conducted solely at YNHH by YNHH health care providers.
Date
YNHH HSPA Name (PRINT) and Signature
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that:

I have read a copy of the protocol and approve it being conducted at YNHH.

I agree to submit a Protocol-Specific Conflict of Interest Disclosure Form if I am aware of any real 
or apparent institutional conflict of interest.

The principal investigator of this study is qualified to serve as P.I. and had the support of the hospital 
for this research project.
APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023

APPROVED BY THE YALE UNIVERSITY IRB 11/2/2023
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SECTION V: RESEARCH PLAN
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.
Specific Aims
Specific Aim #1: To examine the relapse process in postpartum smokers using Ecological 
Momentary Assessment (EMA).
Specific Aim #2: To determine the impact of situational and affective stimuli on relapse in the 
postpartum period.
Specific Aim #3: To examine whether attentional (AR) delivered on a smartphone can modify 
attentional bias to smoking-related stimuli and craving for tobacco cigarettes.
Hypothesis #3: Women randomized to AR, as compared to those in the attentional control 
group, will a) show less attentional bias toward smoking-related stimuli, and b) show a decrease 
in self-reported craving.
Specific Aim #4: To examine whether AR delivered on a smartphone can modify attentional bias to 
stress-related stimuli and reduce perceived stress.
Hypothesis #4: Women randomized to AR, as compared to those in the attentional control 
group, will a) show less attentional bias toward stress-related stimuli, and b) show a decrease in 
self-reported stress.
2. Background: Describe the background information that led to the plan for this project. Provide 
references to support the expectation of obtaining useful scientific data.
The Postnatal Period Presents a Unique Opportunity and Challenge for Smokers
Among the 45 million smokers in the US, pregnancy and the postpartum period presents unique 
opportunities and challenges. Close to half of women who were smokers prior to conception are 
able to quit smoking in pregnancy,1 but nearly 80% of this group relapses within a year after 
delivery, designating pregnancy as a period of “suspended smoking.”2 Smoking in the mother is 
associated with increased risks for cancer, heart disease, and chronic pulmonary disease.
Postpartum smoking may lead to continued smoking into the next pregnancy with associated 
harm to the fetus and the newborn. Equally deleterious are the health effects of second-hand 
smoke on newborns, which include increased risk for respiratory and ear infections, sudden 
infant death syndrome, behavioral dysfunction and cognitive impairment.3 In addition, women 
who smoked pre-pregnancy have less intent to breastfeed4 or cease breastfeeding early in 
order to restart smoking.5 Thus, understanding the underlying triggers for relapse in the 
postpartum period is crucial in ensuring abstinence and creating interventions for women that 
relapse.
Abstinence, Relapse and Ecological Momentary Assessment (EMA)
One of the major challenges to abstinence is the frequent episodes of intense cravings that 
arise due to affective or situational stimuli.6 These episodes of intense craving are high-risk 
periods that often lead to smoking. Most lapses progress to relapse7 and the failure abstinence. 
For this reason it is crucial to study relapse processes in people's natural environments. EMA is 
particularly appropriate for studying the relapse process, because it provides repeated sampling 
of real-world events, as they are influenced by environmental and situational cues. The use of 
EMA allows for the study of dynamic changes in behavior over time and across situations.8 To 
our knowledge, EMA has not been previously used to study smoking relapse in this unique 
patient population.
The Role of Mood Symptoms in Smoking Relapse Among Perinatal Women
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Affective experience has long been considered central to smoking, and stress and negative 
affect (NA) have been considered major drivers of relapse.9  Some evidence suggests that, as 
in a number of other populations,10-12 depressive symptoms moderate smoking outcomes in 
perinatal women.13-16 Stress and dysphoria can be particularly problematic for postpartum 
women. Recently, Cinciripini and colleagues found that behavioral therapy stabilized mood and 
increased abstinence rates among postpartum smokers with depressive symptoms.14 The 
behavioral therapy did not benefit euthymic smokers supporting a moderating role for 
depression and a need to monitor mood among postpartum women with lifetime smoking.
Attentional Bias and Smoking.
Remaining abstinent is an active process that requires attention to avoid slips and lapses. 
When active processes are insufficient or cravings are overwhelming, lapses and relapses 
occur. Automatic processes, such as attentional bias contribute to the relapse process.
Consistent with a classical conditioning paradigm, attentional bias in addictive behaviors is the 
result of repeated pairing between the rewarding effects of drugs and substance-related cues 
(for review see Field & Cox, 2008).17-19 The result is that substance-related cues capture and 
hold the attention of users (attentional bias) and elicit substance-seeking behavior.18,19 Tobacco 
smokers exhibit an attention bias for smoking-related cues such as pictures, words, places or 
memories related to the act of smoking.20-22 Theoretically, increases in attentional bias might be 
both a cause and consequence of high levels of craving. Smokers with high levels of craving are 
more likely to pay attention to smoking-related cues, while prolonged attentional processing of 
smoking related cues may increase urges to smoke. High attentional bias is associated with 
subjective cigarette craving 21 and risk of relapse among abstinent smokers,23,24 and this has 
been confirmed among female smokers.25,26 Thus, attentional bias plays a role in the 
maintenance or escalation of smoking by increasing subjective cravings and/or more directly 
affecting cigarette seeking behavior.24,27,28 Attentional bias to smoking cues remains elevated in 
former smokers,17-19 particularly in naturalistic settings and under conditions of stress. In a 
human laboratory study using the visual probe task (described below), former smokers exhibited 
an attentional bias intermediate between active smokers and never-smokers.29 Animal models 
of relapse consistently demonstrate that drug cues and stress reinstate responding after 
extinction,30-32 and cue-induced craving actually increases over 35 days of abstinence 
(“incubation”) in abstinent smokers.33 This is important because attentional bias predicts 
smoking relapse.23-25 Therefore, manipulation of attentional bias is an important target for 
intervention for smoking relapse.
Assessment of Attentional Bias.
The visual probe (VP) task34 can measure attentional bias for drug-related cues.20,29,35,36 In the 
typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly 
presented simultaneously side by side on a computer screen. After the pictures disappear, a 
probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of 
the pictures (or words), and participants are required to press a key as quickly as possible in 
response to the probe. Attentional bias for drug-related cues is detected by a faster response to 
a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have 
been preferentially allocated to that area of visual display. The traditional VP task only assesses 
attentional bias, and does not modify it in any way.
Attentional Retraining (AR) and Addiction.
Cognitive bias modification (CBM) procedures are interventions aimed at changing the 
impulsive (automatic) processes that underlie unhealthy behaviors such as smoking.37 AR is the 
most commonly used CBM intervention in the study of addiction-related attentional bias. The 
idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, 
because attention to such stimuli may provoke craving and undermine cessation attempts (for 
review see Wiers et al., 2013).38 A modified visual probe task has been utilized to manipulate
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attentional bias and “retrain” individuals’ attention away from drug-related cues.39-42 That is, AR 
administered with the modified VP task can change (and not simply assess) attentional bias.
Two studies have evaluated the effects of AR to enhance abstinence and/or reduce substance 
use in treatment seeking individuals.42,43 A randomized trial of AR in alcohol dependent subjects 
showed that AR, delivered in 5 sessions over 21 days, reduced attentional bias and relapse was 
delayed by over a month after the intervention. In an uncontrolled trial, drinkers with harmful 
alcohol use completed 4 weeks of AR and were found to exhibit a reduction in both attentional 
bias toward alcohol-related stimuli and alcohol consumption, an effect that was maintained 3 
months after the trial.43 AR has been used in the laboratory setting to reduce attentional bias 
toward smoking-related stimuli and blunt cue-provoked craving with success in some,39,40 but 
not all studies.44 Some important limitations to the evidence for AR in smoking is that all studies 
have included a single laboratory session among non-treatment seeking current smokers, unlike 
the alcohol studies that were successful after multiple sessions of AR in treatment seeking 
individuals. Thus, AR for smoking shows promise but some modifications are needed beyond 
what has been employed to date to enhance abstinence.
AR and Anxiety.
AR has also shown promise for the treatment of depression and anxiety, and two meta-analyses 
have confirmed that AR produces significant reductions in anxiety.45,46 Most pertinent to the 
current study, AR also attenuates state anxiety reactions to stressful life events.47,48 The idea 
behind AR for the treatment of anxiety is to minimize the exposure to threat cues that may 
provoke anxiety. See et al. (2009) reported that 15 sessions of AR delivered via a home-based 
AR procedure reduced anxiety associated with transition stress in a naturalistic setting.48 
Postpartum women experience transitional stress, and this is associated with relapse. We posit 
that attending to the pathway between stress/anxiety and relapse will strengthen an AR 
intervention for smoking.
3. Research Plan: Provide an orderly scientific description of the study design and research procedures 
as they directly affect the subjects.
Subjects: Participants will be 50 abstinent smokers, recruited during pregnancy, who provide 
written informed consent. We will recruit participants at the “Women’s Center” and its affiliated 
“Maternal Fetal Medicine High Risk” obstetrical clinics at Yale-New Haven Hospital (YNHH).
Inclusion Criteria: 1) Women with a history of smoking 5+ cigarettes per day that have achieved 
abstinence defined as no smoking or smoking less than 2 cigarettes per week by 32 weeks’ 
gestation during pregnancy by 32 weeks gestation; 2) aged 18 to 40 years; 3) able to speak and 
write English; 4) Edinburgh Postnatal Depression Scale (EPDS) score <10.
Exclusion Criteria: 1) Current substance abuse (e.g., alcohol, benzodiazepines, marijuana); 2) 
current major depressive disorder, minor depression or dysthymia, or history of any of these 
disorders in the last 6 months; 3) presence of an Axis I psychotic disorder; 4) plans to relocate out 
of the area 5) imminent incarceration; 6) planned inpatient hospitalization during study period.
Study Procedures
Overview: We propose to randomize 50 abstinent pregnant smokers to receive either the 
attentional retraining (AR) or control VP task. Participants will be asked to carry around a 
smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy 
(Phase 1). The smartphone will sound an alert randomly during the day, at which time 
participants will be asked to respond to a short set of questions assessing subjective states; this 
will be followed by a request to complete the AR (or control) procedures. This same procedure 
will be repeated for 2 weeks immediately after delivery (Phase 2). Women will undergo a follow-
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up visit 3 months after the end of Phase 2, and complete an unmodified VP and follow-up 
assessments. Given the COVID-19 pandemic screening will be done by phone and study 
visits, with the exception of Visit 1, will be done via Zoom. If/once it is appropriate to 
resume in person visits, participants will be offered the option of completing study visits in 
person at the research clinic or via Zoom.
Screening: 
We will obtain referrals from providers in the reproductive health clinics at Yale New Haven 
Hospital and via the YCCI. Women referred from the prenatal clinics will receive an information 
sheet by their obstetrical provider during a routine prenatal visit that describes the study. 
Women will provide verbal consent if they are interested in being contacted by a study staff, 
and the obstetrical provider will provide their name and contact information to study staff.
 
Referred women will be contacted by phone by a research assistant who will administer a 
screening survey to determine provisional eligibility after providing verbal screening consent. In 
the future, when in person screening is appropriate, we will also have a research assistant 
approach pregnant women in the reproductive health clinics at Yale New Haven Hospital. while 
awaiting a routine visit will be invited to complete the screening survey to determine provisional 
eligibility after providing verbal screening consent. We will invite and consent provisionally 
eligible women to partake in the study. If screening is done by phone women will be provided a 
link for the online consent form via email. Women who are not eligible will be given the number 
for the CT “QUIT” line and educational material (Forever Free for Baby and Me ™).49
At the time of recruitment women will be screened using the following instruments: the PhenX 
Toolkit measures described below, the Fagerstrom Test for Nicotine Dependence (FTND), to 
obtain a quantitative measure of the severity of nicotine dependence.50 A self-report cigarette 
smoking history, including timeline follow-back (TLFB) for the past one week,51,52 the Minnesota 
Nicotine Withdrawal Scale (M-NWS),53 and the Brief Questionnaire on Smoking Urges (QSU- 
brief)54 will also be administered at enrollment. These assessments will be done via an online 
survey, a link for which will be provided by email if done by phone or a study laptop if done in 
person 
Based on their level of smoking women will be stratified into moderate use (5-19 
cigarettes/day) or high use (>20 cigarettes/day). Given the sample size we will not be 
controlling for breastfeeding. However, based on our experience with this population 
approximately half of women choose to breastfeed.
Enrollment: We will follow eligible women that have not reached 32 weeks gestation at the time 
of screening and determine if they are still eligible for randomization. For women who are 
eligible for randomization we will perform an intake interview via Zoom (Visit 1, part a) that will 
include a review of study procedures and consent, and computer administered intake 
assessments (Table 1, Visit 1). Research staff will then coordinate to meet the participant 
before or after a routine prenatal visit to be provided with the study smartphone and home 
breath carbon monoxide monitor (Visit 1, part b). They will undergo a brief training on the use of 
the study program (including a baseline VP task) and the CO monitor on the smartphone. They 
will also be asked to provide a breath sample for carbon monoxide analysis. This entire in 
person visit will last 15 minutes. In the future, parts a and b of Visit 1 can be done as one once it 
is appropriate to conduct routine study visits in person. 
At this point participants will be randomized to one of the two study conditions: attentional 
retraining (AR) or control. All enrolled women will be provided with educational materials to help 
them maintain abstinence from smoking.
Urn Randomization: Eligible women will be assigned to the two study conditions through “urn” 
randomization to ensure relatively equal allocation between treatment group (AR) and control 
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with respect to age and severity of nicotine dependence. In urn randomization, an algorithm 
modifies ongoing randomization probabilities based on the prior composition of treatment 
groups,55 thus the allocation sequence is not pre-specified so allocation concealment is not 
necessary (see Sofuoglu et al. 2007).56 To distribute age evenly over the two groups, a 
categorical variable will be created, 1= ages 18 to 30 and 2 for >30, because older women are 
more likely to achieve abstinence.1 To explicitly require balance between groups with respect to 
level of dependence, a categorical variable will be created based on the number of 
cigarettes/day in the month before conception: 1=1-10; and 2=11 or more cigarettes on 
average, per day. Lastly, we will balance groups with respect to women with and without an 
anxiety disorder. Both the participant and the research assistant will be blinded as to the 
condition. Both the participant and the research assistant will be blinded as to the condition 
assignment.
Intervention Phase 1- Pregnancy: Following enrollment and randomization women will be 
asked to carry a smartphone as they go about their daily lives and complete 2 random 
assessments per day and an AB assessment every day for 2 weeks. Random assessments are 
comprised of questions assessing subjective states (see section d) and the AR (or control) 
procedure (described below). Data from each of the random assessments and AB assessments 
are transmitted in real-time allowing compliance to be assessed. If a participant responds to less 
than 2 random assessments on any study day a research assistant will contact the participant to 
encourage them to maintain compliance. At the end of the two weeks women will complete Visit 
2 via Zoom and complete a post-training unmodified VP task and the Visit 2 assessments 
outlined in Table 1 and described below. If/once it is appropriate to resume in person visits, 
participants will be given the option of completing this visit in person at the research clinic.
All EMA procedures and VP tasks will be conducted on a smartphone running an application 
programmed by Terminal C, a Houston-based company.
Intervention Phase 2- Postpartum: Within 4 days of delivery, women will complete another VP 
task) and the Visit 3 assessments (Table 1). Participants will be asked to repeat the same 
procedure as in Phase 1, 2 random assessments per day and an AB assessment every day for 
2 weeks. Once again at the end of 2 weeks they will schedule a visit via Zoom and complete an 
unmodified VP task and Visit 4 assessments. If/once it is appropriate to resume in person visits, 
participants will be given the option of completing this visit in person at the research clinic.
Post-treatment Visit: Follow-up visits, 5 and 6, will be scheduled 3 and 6 months, respectively, 
after phase 2. Women will complete an unmodified VP task and the assessments listed in Table 
1. Again visits will be done via Zoom; if/once it is appropriate to resume in person visits, 
participants will be offered the option of completing these visits in person at the research clinic.
Assessments: A summary of the timing of assessments is shown in Table 1.
a)
Screening and Enrollment Assessments: The study screening form will collect 
personal contact information and significant other contact information. This will be kept in 
a file that is separate from study assessments. In this way, sensitive data cannot be 
linked with participant information that could lead to a breach of confidentiality. The 
following PhenX Toolkit measures will be used at enrollment: General Psychiatric 
Assessment (without the PTSD and anxiety subsections), Substance Abuse and 
Dependence measure for alcohol, drugs and tobacco, and the Tobacco Protocols. The 
General Anxiety Disorder-7 (GAD-7) and PTSD Checklist for DSM-5 (PCL-5), validated 
tools to assess for anxiety and PTSD, respectively.  Fagerstrom Test for Nicotine 
Dependence (FTND) consists of six items that give a quantitative measure of the 
severity of nicotine dependence.57 The Penn State Electronic Cigarette Dependence 
Index (PSECDI), will be used to assess electronic cigarette use using a standardized 
validated tool.80 The FTND is closely related to biochemical indices (e.g., CO levels, 
plasma cotinine) of tobacco smoking. The Edinburgh Postnatal Depression Scale 
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(EPDS) will measure depressive symptoms.58,59 It is designed specifically for use with 
pregnant and postpartum women. The scale is 10 items, internally consistent 
(Cronbach’s  = 0.87) and has been used in multiple different languages and different 
cultures. The Modified Kendler Social Support Interview (MKSSI)60,61 is a 21 item 
scale that measures social support from family and friends. We modified it and 
determined its psychometric properties in perinatal women.61 Principal components 
analyses found that there is a single dominant factor. We will use the 19-item self-rated 
Pittsburgh Sleep Quality Index (PSQI),62 to measure sleep quality; a cut-off of 5 has 
90% sensitivity and 87% specificity to discriminate between “good”/“poor” sleepers, and 
has been used in postpartum women 63 (visits 2-5). Breath carbon monoxide will also be 
measured. 
b)
Smoking cessation outcomes (Visits 1-6): Expired breath carbon monoxide (CO) level 
will be determined with CoVita piCO+ Smokerlyzer device if a visit is done in person or 
with Covita iCO™ Smokerlyzer® monitors for remote visits. The iCO monitors simply 
plug into a smartphone. During remote visits participants will be required to breathe into 
the CO monitor in front of a member of the research team. Participants can email or call 
the project staff if they experience any difficulties with the CO monitor. Breath CO levels 
are only sensitive to recent smoking because of its short half-life (2 to 3hours). For 
smoking abstinence, a CO level of < 8 ppm will be used.64 Self-report cigarette 
smoking history including timeline follow-back (TLFB) for the past one week. 
Minnesota Nicotine Withdrawal Scale (M-NWS) assesses DSM-IV symptoms of 
tobacco withdrawal such as craving for nicotine, irritability, anxiety, difficulty 
concentrating, restlessness, headaches, fatigue, increased appetite, weight gain and 
insomnia.53 Subjects are asked to rate the presence of symptoms on a scale from “0” 
(not present) to “3” (severe). Brief Questionnaire on Smoking Urges (QSU-brief) is a 
10-item scale originally developed by Tiffany and Drobes.54  This scale has been found 
to be highly reliable and reflects levels of nicotine deprivation.67,68 Similar to NWSC, this 
scale will be used to monitor abstinence- and cue-induced cigarette craving. This scale 
will be used to monitor response to treatment. Smoking intention questions will be asked 
at screening, Visit 1 (enrollment).
c)
Stress and anxiety outcomes (Visits 1-6): The Perceived Stress Scale (PSS) will be used to 
assess stress at study visits and the short form (4-items) on the final daily smartphone assessment 
(see Table 2). The PSS has high reliability in a smoking cessation sample (Cronbach’s α=.86).69 
The state scale of the Spielberger State-Trait Anxiety Inventory (STAI-S)70 (Cronbach’s α=.89)71 
will be used to assess the impact of the transition stressor, arrival of new baby, on anxious mood 
state and to determine whether this is affected by AR. The Parenting Stress Index (PSI)-Short 
Form,72 an established measure of parent and child behaviors, can assess a wide range of 
parenting behaviors with good reliability (Cronbach's α=.83). To assess for race-related stress 
among African American participants we will use the Index of Race-Related Stress–Brief 
Version (IRRS-B), a 22- item measure of race-related stress on cultural (Cronbach's α=.78), 
institutional (Cronbach's α=.69), and individual (Cronbach's α=.78) racism.73 Based on feedback 
from participants we have added a sentence to the introduction of the IRRS-B that acknowledges 
some of the language used in this questionnaire may be considered "dated" by some individuals 
and may not reflect current preferences for racial identity. To assess for cultural stress among 
Hispanic women we will use the Hispanic Stress Inventory-2 (HSI2), which has both an 
immigrant (Cronbach’s α = .97) and US-born version (Cronbach’s α = .93).74 Social support as a 
measure of stress will be assessed on the final daily smartphone assessment via an adapted form 
of the 6-item version of the Social Support Questionnaire.76
d)
Smartphone Assessments: Participants respond to the following items on 7-point 
Likert-type scales (1 = Strongly Disagree,  7 = Strongly Agree) according to how they 
feel “right now”: 1) Craving - A single item is used to assess craving for cigarettes; 2) 
Difficulty concentrating - A single item will be administered to evaluate difficulty 
concentrating, used in previous EMA studies;75 3) Affect - Items include: enthusiastic, 
happy, relaxed, bored, sad, anxious, angry. Two additional items assess overall mood 
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and energy/arousal levels; 4) Parenting stress – 2 items adapted from the Parenting 
Stress Index72 (can’t handle things, trapped by parenting) will be administered; 5) Self-
reported attention capture - 3 items will be used to assess the subjective sense to which 
the participant feels that their attention has been captured by smoking stimuli (e.g., 
“Since the last assessment, how often have you found yourself staring at cigarettes and 
cigarette smoke?”); 6) Environment - 3 items assess testing and lighting conditions (e.g., 
whether they are currently indoors or outdoors); 2 items assess context (whether 
participants are alone or with others, and whether they are at home/work/ in transit/at a 
bar or restaurant/somewhere else); 7) Lapses - 2 items assess the recency of the last 
cigarette smoked; 8) 2 items to assess the degree of alcohol/coffee drunk in the past two 
hours.
e)
COVID-19: We will assess the impacts of the COVID-19 pandemic. This will help 
determine the impact of COVID-19 on participants and their anxiety or smoking 
behavior. This questions have participants rate questions on a scale (1= not at all, 5 = to 
a great degree) access affect (“To what extent has coronavirus affected your income?”)., 
supplies (“To what extent has conronavirus affected your ability to get food and supplies 
to take care of your family and household?”), support (“To what extent has coronavirus 
affected the level of support you normally receive from family, friends, and your 
community?”) , healthcare (“To what extent has coronavirus affected your ability to get 
the healthcare you need for yourself and/or your baby?”), depression (“To’ what extent 
has coronavirus increased your feelings of depression?”),  anxiety (“To what extent has 
corona virus made you more anxious?”), and impact (‘I frequently spend time thinking 
about coronavirus and its impact on my life?”).  
Smartphones: All EMA procedures will be conducted on Apple iPhones. Application 
programming will be done by Terminal C, a Houston-based company. Participants need not 
possess any computer skills or know how to type. In addition, participants will be locked out of 
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all functions other than our program. Thus, other programs cannot confuse them. The main 
smartphone functions will be disabled (e.g. they will not have voice or text capabilities) and 
therefore are essentially worthless for anything but delivering the study application. Because of 
its small size (i.e., roughly equivalent in size to a pack of cigarettes), the smartphone is easy to 
carry in a pocket or purse. Learning to use the smartphone is very simple and does not require 
previous computer experience. Participants can email or call the project staff if they experience 
any difficulties with the smartphone.
AR Intervention: Women randomized to AR will be scheduled to complete 2 AR tasks per day. 
On the AR tasks, the dot always replaces the neutral picture (or word). There is a perfect 
correlation between picture type and dot location. Consistent with prior work each AR task will 
target both the initial orienting of attention (40 trials x 200 ms picture presentation) and the 
disengagement of attention (40 trials x 500 ms picture presentation).42 Based on pilot data, the 
mean duration of AR (and control) assessments is expected to be about 5-7 minutes. There will 
be 2 types of AR interventions, one targeting smoking-related stimuli and one targeting stress. 
The type of AR (smoking vs. stress) will alternate daily between the 2 AR tasks. For the 
smoking AR intervention we plan to use 15 picture sets of consisting of 20 culturally appropriate 
picture pairs (one smoking-related and one neutral) each. One picture set will be administered 
on each study day (days 0-14 in pregnancy and days 0-14 postpartum). For the stress AR 
intervention we plan to use 15 culturally appropriate word sets with 20 word pairs each. Word 
pairs consist of one emotionally neutral rated word (e.g. book) and an emotionally negative 
rated word (e.g. fear). We base this on the work of See et al., who demonstrated that AR was 
effective in inducing attentional avoidance of negative/stressful information (words), thus 
reducing anxiety related to a naturalistic stressor.48 Again one word set will be administered on 
each study day (days 0-14 in pregnancy/postpartum). To facilitate compliance, a “delay” option 
will allow women to delay their response by 5 minutes, a “suspend” option will prevent the 
phone from presenting assessments for a specific time period, and a “make-up” option will allow 
women to complete trainings if they miss an AR or have technical difficulties (e.g. program 
crashes and prevents random assessment from being presented). The program is operational 
independent of internet connectivity, as it will run directly on the smartphone. Data will be stored 
on the phone and wirelessly backed-up on a server.
Control Condition: The control task is identical to the AR task in number of tasks per day, 
number of trials per task (80 trials: 40 x 200ms and 40 x 500ms picture presentation) and the 
types of tasks: one containing smoking-related and neutral pictures (smoking control task), and 
one with stress-related and neutral words (stress control task). The only difference is that in the 
control task, the dot is equally likely to replace the smoking picture (or stress-related word) and 
the neutral picture (or word). There is a zero correlation between picture type and dot location, 
therefore there is no effect on AB. This type of control condition has been used in previous AR 
studies77 and in our own pilot study, and ensures that: 1) the duration of AR and control training 
should not differ; 2) AR and control participants receive equal practice on the motoric aspects of 
the VP tasks; and 3) AR and control participants are exposed to the same smoking and neutral 
pictures or stress-related and neutral words. Note that, apart from the number of trials, the 
control task is the same as the standard VP task.
Attentional Bias Assessment: We will assess attentional bias using the standard VP task on 
the final random assessment of each day. Consistent with the AR task and prior work,42 the VP 
task will have stimulus presentation durations of 200 ms and 500 ms at each assessment. This 
will allow us to assess both the initial orienting of attention (20 trials x 200 ms) as well as the 
difficulty disengaging attention (20 trials x 500 ms), for a total of 40 trials.17 It will include a 
balance of both smoking and stress cues. Processing of reaction time data and computation of 
attentional bias will follow existing procedures.22,78 Reaction times (RTs) will be computed from 
trials with correct responses. We will compute attentional bias scores as the difference in RTs 
on trials where the probe replaced the smoking picture (or stress-related word) vs. trials where 
the probe replaced the neutral picture (or neutral word). Faster RTs on the former reflects an 
attentional bias towards to the smoking picture/stress-related word, or vigilance. Faster RTs on 
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the latter reflects an attentional bias away from the smoking picture/stress-related word, or 
avoidance.
4. Statistical Considerations: Describe the statistical analyses that support the study design.
Data Analysis: Given the small sample size and the goal of feasibility, we will plot the potential 
mediator/moderator covariates and relapse over time. These data will be exploratory only but 
will provide a rough assessment of the process of relapse (Hypothesis #1) in relation to a 
number of covariates. We will use Generalized Estimating Equations (GEE)79 to evaluate the 
relationship between the “sad” mood measure and risk of relapse to smoking. For Hypothesis 3 
and 4, assuming normal distribution of attentional bias toward smoking and stress cues we will 
utilize a linear mixed model (LMM) to compare change in the intervention group to change in the 
control group (see Table 2). Mixed models allow for missing observations and within subject 
clustering. The best fitting correlation structure will be selected based on Schwartz-Bayesian 
criterion. We will use all available data in an intention-to-treat analysis. Assessment number and 
assessment number-group interaction will be included in the model as fixed effects. The overall 
difference in slopes between the two groups will be tested. Presentation duration, a categorical 
variable with two levels (200 ms vs. 500 ms), will also be included as a fixed effect. If data are 
not normally distributed, we will attempt transformation to normality. If data are skewed and 
complied at zero, we will use a generalized linear mixed model and approximate data by a 
Poisson distribution, a Zero-Inflated Poisson distribution (ZIP) or a negative binomial 
distribution. If parametric models are not appropriate, we will use a nonparametric approach for 
repeated measures. Attentional bias outcomes assessed in the lab will also be examined using 
LMMs. Analysis for cravings and stress will be similar except that presentation duration factor 
will not be included; for craving, an additional categorical variable, number of assessment within 
the day, will be included. We realize that there will be limited power for this statistical analysis 
but we will be able to detect large effects.
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SECTION VI: RESEARCH INVOLVING DRUGS, DEVICES, BIOLOGICS & PLACEBOS
Are there any investigational devices used or investigational procedures performed in a YNHH 
Operating Room? Yes
No 
    If Yes, please be aware of the following requirements:
1. Identification of Drug, Device or Biologic: What is (are) the name(s) of the drug(s), device(s) or 
biologic(s) being used? Identify whether FDA approval has been granted and for what indication(s).
All protocols which utilize a drug, device or biologic not approved by, but regulated by, the FDA must 
provide the following information:  
Not applicable to this research project
1. Recruitment Procedures: Describe how potential subjects will be identified, contacted and 
recruited.
We will obtain referrals from providers in the reproductive health clinics at Yale New Haven 
Hospital and via the YCCI. YCCI has an ever growing “Help us Discover” database of 
approximately 8,000 valid email addresses of individuals who have volunteered to be contacted 
about clinical research at Yale. The emails go out periodically to the database and study teams 
have found that interest and recruitment for their clinical trial has greatly increased after an 
email campaign.
Referred women will be contacted by phone by a research assistant who will administer a 
screening survey to determine provisional eligibility after providing verbal screening consent. In 
the future, when in person screening is appropriate, pregnant women awaiting a routine visit in 
the reproductive health clinics at Yale New Haven Hospital will be approached by a research 
assistant and invited to complete a screening survey to determine provisional eligibility after 
providing screening consent. We will invite and consent provisionally eligible women to partake 
in the study. After screening, women who are not eligible will still be offered referrals.
1.a Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
Flyers  (in OB/Gyn clinic)
 Internet/Web Postings
 Radio
 Posters
 Mass E-mail Solicitation
 Telephone
 Letter
 Departmental/Center Website
 Television
Medical Record Review
 Departmental/Center Research Boards
 Newspaper
 Departmental/Center Newsletters
 Web-Based Clinical Trial Registries
 Other (describe): YCCI “Help us Discover” database and Joint Data Analytics Team (JDAT) reports of eligible 
participants
 Clinicaltrials.gov Registry (do not send materials to HIC)
2. 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
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 Yes, some of the subjects
 No
If yes, describe the nature of this relationship. 
2. Subject Population Provide a detailed description of the targeted involvement of human subjects 
for this research project.
All participants will be women, as only women can become pregnant. Participants must be age 
18 or above, with a recent problem of nicotine dependence. Previous work with this population in 
this same clinic yielded a subject sample averaging 25.5 years old, 3.3 previous pregnancies and
1.2 other children in the home. We anticipate the following racial/ethnic breakdown in our sample, 
based upon previous work with the same population in the same clinic: 47% African American, 
30% Caucasian, 23% Hispanic. Given the use of specialized smartphone program we have 
determined to offer the study only to English-speaking patients, and do not believe this will limit 
recruitment nor access to care for patients in need.
3. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or 
exclusion? How will eligibility be determined, and by whom?
Inclusion Criteria: 1) Women with a history of smoking 5+ cigarettes per day that have achieved 
abstinence during pregnancy, with abstinence defined as no smoking or smoking less than 2 
cigarettes per week by 32 weeks’ gestation; 2) aged 18 to 40 years; 3) able to speak and write 
English; 4) Edinburgh Postnatal Depression Scale (EPDS) score <10; 5) have biologically 
confirmed abstinence from tobacco and other nicotine products at randomization.
Exclusion Criteria: 1) Current substance use, with the exception of cannabis, if not used in a 
combustible form (e.g. edibles, teas, tinctures, etc.); 2) current major depressive disorder, minor 
depression or dysthymia, or history of any of these disorders in the last 6 months; 3) presence of 
an Axis I psychotic disorder; 4) plans to relocate out of the area 5) imminent incarceration; 6) 
planned inpatient hospitalization during study period.
The PI or research staff will screen potential subjects using the assessments described under 
study procedures. This includes modules from Addiction Severity Index, the Edinburgh 
Postnatal Depression Scale, the PhenX Toolkit measures (see Table 1). At intake, postpartum, 
subjects will complete the Kendler Social Support Inventory, Parenting Stress Index and a 
Substance Use Calendar. In addition, they will undergo an expired CO breath test to confirm 
smoking abstinence, at the time of enrollment (Visit 1, see Table 1 above). After assessments 
the PI will confirm whether or not the respondents met criteria outlined above.
4.a. Will email or telephone correspondence be used to screen potential subjects for eligibility 
prior to the potential subject coming to the research office?
xYes
No
4.b. If yes, will identifiable health information be collected during this screening process and 
retained by the research team?
xYes
No
5. Subject Classifications: Check off all classifications of subjects that will be invited to enroll in 
the research project. Will subjects, who may require additional safeguards or other 
considerations, be enrolled 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
 Students 
Females of childbearing potential
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5.a. Is this research proposal designed to enroll children who are wards of the state as potential subjects? 
 
Yes  
 No (If yes, see Instructions section VII #4 for further requirements) 
1. Consent Personnel: Please see IRES-IRB.
2. 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.
All potential participants are asked to provide written informed consent for study participation. 
Study visits, including intake, are scheduled as independent visits and are held at our research 
office where meeting spaces are private and confidential. Participants will be told that they are 
not protected against mandatory reporting of child abuse, suicidality or homicidality.
3. 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.
All patients will be required to be competent to sign written informed consent. Capacity to 
consent will be assessed in a systematic format. Any subject that is interviewed and appears to 
have limited decision-making capacity will undergo further evaluation of capacity to consent.
Ultimately, the PI will determine the capacity to consent in any case where it may be in doubt. 
Cases will be treated on a case-by-case basis with the PI making the final decision on cases of 
questionable capacity to consent. Patients that are determined by the PI to not possess the 
capacity to provide consent will be provided with information on smoking and a referral list for 
agencies and treatment providers.
4. Documentation of Consent/Assent: Specify the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects.
Women referred from the prenatal clinics will receive an information sheet by their obstetrical 
provider during a routine prenatal visit that describes the study. Women will provide verbal 
consent if they are interested in being contacted by a study staff, and the obstetrical provider 
will provide their name and contact information to study staff. Referred women will be contacted 
by phone by a research assistant who will administer a screening survey to determine 
provisional eligibility after providing verbal screening consent. At this point if women are 
preliminarily eligible they will be invited to participate in the study and undergo formal (signed) 
informed consent as outlined below. Women who are not provisionally eligible will be thanked 
for their participation in the screening process and given a $20 Amazon e-gift card. 
The procedure for obtaining informed consent entails a face-to-face or Zoom discussion between 
the potential subject and a trained member of the research staff. The entire protocol and all of its 
requirements are explained at length. Additionally, women are encouraged to ask questions about 
any confusing points. Subjects are told that they may withdraw from the project at any time, 
without prejudice, and without any adverse effect on their medical care at their prenatal clinic.
5. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for 
research involving non-English speaking subjects. Translated copies of all consent materials must 
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be submitted for approval prior to use.
Not applicable to this study.
6. Waiver of Consent: Will you request either a waiver of consent, or a waiver of signed consent, for 
this study? If so, please address the following:
Waiver of consent: (No consent form from subjects will be obtained.)
a.
Does the research pose greater than minimal risk to subjects?
Yes
xNo
b.
Will the waiver adversely affect subjects’ rights and welfare?
Yes
xNo
c.
Why would the research be impracticable to conduct without the waiver?
•
Without the waiver, we would be unable to identify patients who may be eligible 
through the electronic health record (EHR). Given the limitations for in-person presence 
at clinical sites due to the COVID-19 pandemic, we rely primarily on identifying 
potentially eligible participants via EHR. Without this we would be unable to meet our 
recruitment and target enrollment. It is not feasible to obtain consent a prior for the 
EHR searches conducted by JDAT. We will not be collecting any data from the 
searches other than name and phone number of potentially eligible subjects. If we 
identify potentially eligible subjects, they will be asked for full consent before deciding 
to participate in the study. 
d.
Where appropriate, how will pertinent information be returned to, or shared with subjects 
at a later date? N/A
Waiver of signed consent: (Verbal consent from subjects will be obtained.)  For screening only. Women 
will be given an information sheet by their obstetrical provider briefly describing the study and the 
screening process for which they will provide verbal consent to be contacted.
 This section is not applicable to this research project
a.
Would the signed consent form be the only record linking the subject and the research?
xYes
No
b.
Does a breach of confidentiality constitute the principal risk to subjects?
xYes
No
OR
c.
Does the research pose greater than minimal risk?
Yes
No AND
d.
Does the research include any activities that would require signed consent in a non- 
research context?
Yes
No
7. Required HIPAA Authorization: If the research involves the creation, use or disclosure of 
protected health information (PHI), separate subject authorization is required under the HIPAA 
Privacy Rule. Indicate which of the following forms are being provided:
Compound Consent and Authorization form 
HIPAA Research Authorization Form
8. 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.
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i.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure 
of this data: 
It is not feasible to obtain consent a prior for the EHR searches conducted by JDAT. We 
are unable to know ahead of time which patients might meet eligibility criteria and 
therefore have no way of obtaining consent. The waiver of HIPPA authorization allows us 
to identify patients who are potentially eligible via the EHR searches conducted by JDAT. 
We would utilize the name and phone number of potential participants to complete 
phone screenings. Again, since this information is collected via EHR searches we are 
unable to obtain consent to call participants ahead of time. At the time of the phone 
screening, we will obtain verbal consent to conduct the screening call, and they will be 
asked for full signed consent before deciding to participate in the study. As noted 
elsewhere in the protocol, we have procedures in place that allow us to obtain signed 
consent remotely.
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.
1. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, 
or inconveniences associated with subjects participating in the research.
Questionnaires and interviews will contain items of a personal nature. It is possible that the 
process of psychiatric interview may feel uncomfortable for some respondents. It is unlikely that 
completion of the questionnaires will lead to any legal, social, or psychological problems.
Another potential risk is the loss of privacy. There are no known risks associated with the 
subjective assessments related to the smartphone assessments. There are no data to suggest 
that the attentional retraining or control task promotes smoking, although this will be monitored 
carefully. The use of the CoVita iCO+ Smokerlyzer device, per se, do not pose risk to the 
subject. There is no reason to believe that participants’ smoking will be increased by 
participation in the study.
2. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
Any potential discomfort with the completion of the screening questionnaire and psychiatric 
interview will be minimized by appropriately preparing the patient for the computerized 
assessment by the PI or research staff trained to deal with such difficulties and explaining the 
study, consenting, and screening women in private. 
Loss of privacy is minimized with the self-administered assessments since only the subject 
completing the interview can read the interview questions and responses. These assessments 
will be identified by the subject ID number only, maintaining the anonymity of the responses.
Other data collected for this protocol will be kept in a research chart and this information will 
only be available to research staff unless the imminent safety of the participant or her 
dependents is at risk (see below). Smokers will have the option of declining to answer any 
questions that they find objectionable, or of withdrawing from the study at any time.
3. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan 
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(DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make the 
final determination of the risk to subjects.) For more information, see the Instructions, page 24.
a.
What is the investigator’s assessment of the overall risk level for subjects 
participating in this study? The study does not involve investigational drugs. The 
risks to the participants are low.
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.
Data and Safety Monitoring Plan
For Data and Safety Monitoring Plan templates, see 
http://www.yale.edu/hrpp/forms-templates/biomedical.html
The principal investigator is responsible for monitoring the data, assuring protocol compliance, 
and conducting the safety reviews at the specified frequency, quarterly. During the review 
process the principal investigator will evaluate whether the study should continue unchanged, 
require modification/amendment, continue or close to enrollment.
Either the principal investigator or the Human Investigation Committee (HIC) have the authority 
to stop or suspend the study or require modifications.
This protocol presents minimal risks to the subjects and adverse events or other problems are 
not anticipated. In the unlikely event that such events occur, serious and unanticipated and 
related adverse events or unanticipated problems involving risks to subjects or others will be 
reported in writing within 5 days to the HIC (using the appropriate HIC forms from the website) 
and any appropriate funding and regulatory agencies. The investigator will apprise fellow 
investigators and study personnel of all adverse events that occur during the conduct of this 
research project through regular study meetings or via email as they are reviewed by the 
principal investigator. The Clinical Supervisor will review subjects’ safety daily and will present 
subjects’ clinical status and adverse experiences in the weekly Study Personnel meeting.
Entrance criteria of all subjects are reviewed at this meeting including results of screening 
assessments. The referral to appropriate care for subjects who endorse clinical deterioration 
will be monitored at this meeting. The PI will oversee appropriate assessment and referral for 
these subjects, and ensure that information on subjects’ adverse effects are systematically 
collected and evaluated.
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?
ii. What provisions are in place for management of interim results?
iii. What will the multi-site process be for protocol modifications?
4.
Confidentiality & Security of Data:
a.
What protected health information about subjects will be collected and used for the research?
Subjects who provide written consent will be asked for the following PHI: Name, Date of 
Birth, Anticipated (or actual) Date of Delivery, home address and telephone number.
b. How will the research data be collected, recorded and stored?
Data will be collected on Qualtrics and saved onto a secure database saved on a secure 
server, managed by our Programmer and, more broadly, by the YUSM ITS department. 
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Any paper files will be locked in a secure file cabinet in a locked office. Computer files are 
accessible by password only, and backups are secured by ITS. Computerized data will be 
identified by subject number only. The data from the smartphone assessments will be 
downloaded to the study computer, which is password protected and secured by ITS. Once 
a subject has completed the study and the smartphone data has been downloaded, the 
smartphone memory will be erased.
c.    How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard   
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
 Other
d.
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 the subject 
participation in the study?
All data will be coded by subject number only and will be locked in research offices. 
Demographic information, subject lists and progress through the study will be entered on the 
PI’s computer which is kept at all times in the locked research clinic office. Access to the 
computer is password-protected. The original clinic screening data will be kept in locked file 
cabinets in the locked research clinic office, identifiable by subject codes only.
The smartphones themselves will be locked out of all functions other than our program to 
avoid confusion or unintended use of the phones. To ensure confidentiality the smartphone 
data collected from each subject will also be coded by subject number only. Patient identities 
will not be directly linked to the smartphone data. In addition, there will be no patient identifiers 
on the smartphones themselves. The smartphones will not store any assessment data, as 
data are wirelessly transmitted to a secure server (after each assessment) where they can be 
retrieved by the investigator. All data are de-identified and encrypted. Therefore, if the subjects 
lose the smartphone or someone else gains access to it there will be no compromise of 
personal information.
Data will be kept confidential and will not be released to the general public. Data will be 
available to research staff, the local IRB and government agencies as required. No subjects 
will be identified by name in any report of the study.
e.
What mechanisms are in place to ensure the proper use and continued protection of these 
data after the subject participation in the study has ceased?
After study completion, data may be provided to other researchers after a written request and 
after any possible identifying information is purged. All disclosure rules pertaining to HIPAA 
will be followed in the exchange of any study data with other researchers.
f.
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 data analysis, this data will be used to support future grant 
submissions. We will not destroy the data until 7 years after study completion. Security 
measures will be the same as noted above.
g. Who will have access to the protected health information? (such as the research sponsor, the 
investigator, the research staff, all research monitors, FDA, QUACS, SSC, etc.)
PHI will be accessible to the PI, Research Staff, and the HRPP.
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h. Which external or internal individuals or agencies (such as the study sponsor, FDA, QUACS,
SSC, etc.) will have access to the study data? HRPP
i.
If appropriate, has a Certificate of Confidentiality been obtained? N/A
j
Are there any mandatory reporting requirements? (Incidents of child abuse, elderly abuse, 
communicable diseases, etc.)
In the unlikely event that we learn of risk of neglect or abuse of a child, we will report this to 
the State of CT DCF Hotline.
5.
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.)
Postpartum smoking may lead to continued smoking into the next pregnancy with associated 
harm to the fetus and the newborn. Perhaps equally harmful are the health effects of second- 
hand smoke on newborns. Women who smoked pre-pregnancy have less intent to breastfeed 
or cease breastfeeding early in order to restart smoking. Women participating in this study will 
be provided with a referral to the CT Quit Line if they relapse. Some participants may reduce 
their smoking over the course of the week. Some participants may experience reduced 
cravings. More broadly, data from the study may help us develop better smoking cessation 
programs. This may be beneficial to smokers and to society. Finally, knowledge gained from 
this study might be beneficial for these future endeavors.
1.
Alternatives: What other alternatives are available to the study subjects outside of the research?
Treatment alternatives include referral to CT Quite Line, case management, and outpatient 
treatment according to the centers’ usual protocol. Subjects may still receive case management 
(e.g. assistance with community resources and/or peer support) from clinic staff, without 
participating in this protocol. Participants will be provided with information regarding smoking 
while pregnant and smoking cessation resources by the research assistant during each visit, if 
necessary. The PARIS study website and introduction packet provides resources for treating 
tobacco use disorder including Smokefree women, CDC and the CT commit to Quit line.  
2.
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. 
Subjects will be compensated as much as $400 for completing the entire study, stratified by visit 
type and assessment completion and will be as follows:
They will be paid $20 for completion of the initial screening assessment. During the study they 
will receive $2 for each smartphone assessment they complete, plus $8 per week for completing 
all assessments for the week (up to $200 for completing all 84 assessments); $20 for each 
study visit (Visits 1-4); and $50 for each follow-up visit (Visit 5 and 6). Compensation for the 
assessments completed in Phase 1 will be provided during Visit 2, and compensation for the 
assessments completed in Phase 2 will be provided during Visit 4. The compensation may 
enhance compliance with all assessments. Compensation will be via Amazon e-gift card, which 
participants will receive after completing a study visit via a link by text or email. 
SECTION X: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
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Participants will be gifted the smartphones as part of their participation in the study once visit 
4 is complete. Once they have completed all both phases of the study the phone will be 
unlocked to all other functions, which are restricted during the study period. Participants 
who complete phases 1 and/or 2, they will be asked to complete a short feedback survey 
which they will be paid $10 for completion.
3.
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.   None  
4.
In Case of Injury: This section is required for any research involving more than minimal risk.
a.
Will medical treatment be available if research-related injury occurs?
b.
Where and from whom may treatment be obtained?
c.
Are there any limits to the treatment being provided?
d.
Who will pay for this treatment?
e.
How will the medical treatment be accessed by subjects?
This study does not entail physical procedures that may cause injury. No compensation is 
available for emotional injury or injury to offspring. All patients enrolled in study are currently 
receiving health care at the study-sponsoring obstetrical clinic.
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APPENDIX
Visual Probe (VP) task
The following is a description of the visual probe task used by Waters et al. (2003). We will be 
following this protocol in our study. The stimuli consisted of color photographs of smoking- 
related scenes (e.g., woman holding a cigarette to mouth). Each was paired with a control 
photograph of another scene lacking any smoking-related cues (e.g., woman applying lipstick). 
Thus, the smoking and control pictures were similar on visual characteristics. The pictures were 
each 500x500 pixels when displayed on the screen.
The task consisted of 160 experimental, which were presented in a new random order for each 
subject. At the start of each trial, a fixation cross was displayed in the center of the screen for 
500 ms. There was an interstimulus interval of approximately 250 ms between the fixation cross 
offset and picture onset (allowing transfer of picture files from hard disc to video memory). The 
picture pair was then presented for 500 ms, one picture each side of the central position. The 
dot probe was displayed immediately after the offset of the pictures, until subjects made a 
response. Participants were told to press one of two keys as quickly and as accurately as 
possible to indicate whether the probe occurred on the left or the right. On the experimental 
trials, each picture pair was presented 4 times. The task took around 10 minutes to complete.
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