A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation
Phase: PHASE2
Conditions: Exercise Sensitivity, Introceptive Exposure, Anxiety, Cardiac Rehabilitation
Sponsor: Rutgers, The State University of New Jersey

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National Institute on Aging (NIA) 
Guidelines for Developing a Single-Site 
Manual of Operations and Procedures (MOP) 
Version 2.1 – March 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
GUIDELINES FOR DEVELOPING A SINGLE-SITE MANUAL OF OPERATIONS AND 
PROCEDURES (MOP) .................................................................................................................1 
ACRONYM GLOSSARY .............................................................................................................4 
INTRODUCTION .........................................................................................................................7 
OVERVIEW ...................................................................................................................................8 
MOP CONTENTS AND ORGANIZATION ..............................................................................9 
1.0 INTRODUCTION ....................................................................................................................9 
2.0 STUDY OVERVIEW ............................................................................................................10 
3.0 STUDY ORGANIZATION AND RESPONSIBILITIES ..................................................11 
Table 1: Staff Roster ................................................................................................................. 12 
4.0 STUDY FLOW .......................................................................................................................15 
Figure 1: Timing of Intervention and Assessment Components .............................................. 15 
5.0 INFORMED CONSENT .......................................................................................................16 
5.1 HIPAA Authorization ......................................................................................................... 16 
6.0 RECRUITMENT AND RETENTION ................................................................................18 
6.1 Participant Recruitment ...................................................................................................... 18 
6.2 Participant Retention ........................................................................................................... 18 
7.0 SCREENING AND ELIGIBILITY CRITERIA ................................................................19 
7.1 Screening ............................................................................................................................. 19 
7.2 Screening Log ..................................................................................................................... 19 
7.3 Eligibility Criteria ............................................................................................................... 20 
8.0 STUDY INTERVENTION ....................................................................................................21 
9.0 RANDOMIZATION ..............................................................................................................22 
10.0 BLINDING AND UNBLINDING (MASKING AND UNMASKING) ...........................23 
11.0 STUDY MEASUREMENTS AND PROCEDURES .......................................................24 
11.1 Timeline and assessment schedule ....................................................................... 26 
11.2 Visit Procedures .......................................................................................................... 27 
11.3 Follow-up ....................................................................................................................... 27 
11.4 Final Study/Early Discontinuation Evaluations .................................................. 27 
12.0 CONCOMITANT MEDICATIONS ...................................................................................28 
13.0 SAFETY REPORTING ......................................................................................................28 
13.1 Adverse Event Reporting .......................................................................................... 28 
13.2 Unanticipated Problems ............................................................................................ 29 
13.3 Serious Adverse Event Reporting .......................................................................... 29 
14.0 STUDY COMPLIANCE .....................................................................................................30 
15.0 DATA COLLECTION AND STUDY FORMS ................................................................31 
15.1 Source Documentation ...................................................................................................... 32 

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15.2 General Instructions for Completing Forms ..................................................................... 32 
15.3 Data Flow .......................................................................................................................... 33 
15.4 Administrative Forms ....................................................................................................... 33 
15.5 Retention of Study Documentation ................................................................................... 33 
16.0 DATA MANAGEMENT .....................................................................................................33 
16.1 Quality Control Procedures ............................................................................................... 34 
16.1.1 Standard Operating Procedures .................................................................. 34 
16.1.2 Data and Form Checks ................................................................................ 35 
16.1.3 Site Monitoring ............................................................................................. 35 
17.0 DATA AND SAFETY MONITORING ACTIVITIES .....................................................36 
17.1 Reports .............................................................................................................................. 36 
17.2 Study Completion and Close-Out Procedures .................................................................. 37 
17.2.1 Participant Notification ................................................................................. 37 
17.2.2 Confidentiality Procedures ........................................................................... 37 
17.2.3 Publications .................................................................................................. 39 
18.0 MOP MAINTENANCE .......................................................................................................39 
APPENDIX A - PROTOCOL .....................................................................................................40 
APPENDIX B - PROTOCOL DEVIATION/VIOLATION LOG ...........................................67 
SAMPLE PROTOCOL DEVIATION / VIOLATION CODES ............................................... 67 
APPENDIX C - CONSENT FORMS .........................................................................................68 
APPENDIX D - MOP MODIFICATION LOG ........................................................................80 
APPENDIX E - ASSESSMENTS ...............................................................................................81 
APPENDIX F – ADVERSE EVENT FORM ..........................................................................102 
APPENDIX G – SERIOUS ADVERSE EVENT FORM .......................................................103 
APPENDIX H - NIA SINGLE-SITE CLINICAL TRIAL CLOSEOUT PROCEDURES .105 
I. 
INTRODUCTION .......................................................................................................... 105 
Purpose 105 
Types of Closeout ................................................................................................................ 105 
II. 
SITE CLOSEOUT .......................................................................................................... 105 
Study Documentation List ................................................................................................... 106 
Study Closeout Checklist .................................................................................................... 107 
III. 
PARTICIPANT RIGHTS AND NOTIFICATION .................................................... 107 
IV. 
INSTITUTE RESPONSIBILITIES ............................................................................ 107 
 
 
 

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ACRONYM GLOSSARY 
Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a clinical 
research study participant, including any abnormal sign (e.g. abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the participants’ 
involvement in the research, whether or not considered related to participation in the 
research. 
Case Report Form (CRF) – A printed, optical, or electronic (eCRF) document designed 
to capture all protocol-required information for a study.  
Clinical Research or Study Coordinator (CRC) – An individual that handles the 
administrative and day-to-day responsibilities of a clinical trial. This person may collect 
or review data before it is entered in the study database. 
Data and Safety Monitoring Committee (DSMC) – A group of individuals independent 
of the study investigators that is appointed to monitor participant safety, data quality and 
to assess clinical trial progress.  
Electrocardiogram (ECG) – A record or display of a person's heartbeat produced by 
electrocardiography. 
Good Clinical Practice (GCP) – A standard for the design, conduct, performance, 
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides 
assurance that the data and reported results are credible and accurate, and that the 
rights, integrity, and confidentiality of trial participants are protected. 
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule – The 
first comprehensive Federal protection for the privacy of personal health information. 
The Privacy Rule regulates the way certain health care groups, organizations, or 
businesses, called covered entities under the Rule, handle the individually identifiable 
health information known as protected health information (PHI). 
ID – Identification 
Informed Consent Form (ICF) – A process by which a subject voluntarily confirms his 
or her willingness to participate in a particular trial, after having been informed of all 
aspects of the trial that are relevant to the subject’s decision to participate. Informed 
consent is documented by means of a written, signed, and dated informed consent 
form. 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – An 
independent body constituted of medical, scientific, and nonscientific members whose 
responsibility it is to ensure the protection of the rights, safety, and well-being of human 
subjects involved in a trial by, among other things, reviewing, approving, and providing 
continuing review of trials, protocols and amendments, and of the methods and material 
to be used to obtaining and documenting informed consent of the trial participant. 
Manual of Procedures (MOP) – A “cook book” that translates the protocol into a set of 
operational procedures to guide study conduct. A MOP is developed to facilitate 

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consistency in protocol implementation and data collection across study participants 
and clinical sites.  
NIA – National Institute of Aging  
NIH – National Institutes of Health  
Not Applicable (NA) – When recording data on a study form, if the information is not 
applicable, then the acronym NA should be used to fill out the field.  
Not Available (NAV) – When recording data on a study form, if the information is not 
available, then the acronym NAV should be used to fill out the field. 
Not Done (ND) – When recording data on a study form, if the evaluation required for a 
field is not done, then the acronym ND should be used to fill out the field 
Office for Human Research Protection (OHRP) – A federal government agency within 
the Department of Health and Human Services (DHHS) charged with the protection of 
human subjects participating in government-supported research. The OHRP issues 
assurances to institutions reviewing human subjects research and oversees compliance 
of regulatory guidelines by research institutions.  
Package Insert – A compilation of the clinical and nonclinical data on the 
investigational product(s) that is relevant to the study of the investigational product(s) in 
human subjects. 
Principal Investigator (PI) – The individual with primary responsibility for achieving the 
technical success of the project, while also complying with the financial and 
administrative policies and regulations associated with the award. Although Principal 
Investigators may have administrative staff to assist them with the management of 
project funds, the ultimate responsibility for the management of the sponsored research 
award rests with the Principal Investigator. 
Protected Health Information (PHI) – A subset of individually identifiable health 
information, oral or recorded, relating to a subject’s past, present, or future physical or 
mental health or condition (e.g., medical or research record). The institutional review 
board (IRB) or Privacy Board may determine what is considered PHI; however, in 
general, PHI includes health information that is linked to identifiers of the individual or of 
relatives, employers, or household members of the individual. Some common identifiers 
of health information include names, social security numbers, addresses, and birth 
dates, among others. 
Quality Control (QC) – The internal operational techniques and activities undertaken 
within the quality assurance system to verify that the requirements for quality of trial 
related activities have been fulfilled (e.g., data and form checks, monitoring by study 
staff, routine reports, correction actions, etc.) 
Safety Officer (SO) – The Safety Officer is an independent individual, usually a 
clinician, who performs data and safety monitoring activities in low-risk, single site 
clinical studies. The Safety Officer advises NIA Program Director regarding participant 
safety, scientific integrity and ethical conduct of a study. 
Serious Adverse Event (SAE) – Any adverse event that: 

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• Results in death  
• Is life threatening, or places the participant at immediate risk of death from the 
event as it occurred  
• Requires or prolongs hospitalization  
• Causes persistent or significant disability or incapacity  
• Results in congenital anomalies or birth defects  
• Is another condition which investigators judge to represent significant hazards 
Standard Operating Procedure (SOPs) – Detailed written instructions to achieve 
uniformity of the performance of a specific function across studies and patients at an 
individual site. 
 
 

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INTRODUCTION  
The purpose of this document is to provide a Manual of Operating Procedures (MOP) 
template for Principal Investigators of single-site clinical trials.  NIA defines a single-site 
study as a trial that is conducted by a single funded institution implementing a trial. The 
role of the MOP is to facilitate consistency in study implementation and data collection 
across study visits and participants. Use of the MOP increases the likelihood that the 
results of the study will be scientifically credible, that participant safety will be protected, 
and scientific integrity will be closely monitored. 
In preparing the MOP, the Principal Investigator must be aware of the terms of award 
with respect to required reporting, data and safety monitoring, and Institutional Review 
Board (IRB) approval (see NIA Guidance on Clinical Trials). All staff members 
participating in the conduct of this study at participating institutions should have ready 
access to the MOP and be trained on contents.   
The protocol, case report forms (CRFs), informed consent documents, and 
administrative forms (e.g., screening and enrollment log, protocol deviation log, etc.) 
should be finalized before the development of the MOP. Additionally, the MOP should 
be drafted prior to study commencement.  
 
 

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Overview 
A MOP serves as a reference and handbook that details a study’s conduct and operations. 
Its purpose is to provide the operational detail to ensure that study procedures are carried 
out consistently. The MOP is intended to serve as a study “cookbook” that facilitates 
adherence to study procedures to promote high quality research and to help clinical 
investigators comply with federal regulations and procedures, and good clinical practice 
(GCP). 
The study team (investigators, coordinators, statisticians, etc.) develops the MOP before 
the study can commence and keeps it updated throughout the study to record and 
implement amendments to the protocol and to document refinement of procedures. 
MOP development requires complete versions of a final protocol, study forms (often called 
case report forms (CRFs), Package Insert or Device Manual, if applicable, and Informed 
Consent Form (ICF).  
During a study's planning phase, the Principal Investigator and study staff draft the 
protocol. The protocol must be approved by the Institutional Review Board (IRB) of record 
for the study, and by the Data and Safety Monitoring Board (DSMB) or Safety Officer (SO). 
Prior to developing the MOP, the final protocol, CRFs, informed consent forms, and 
administrative forms (e.g., screening and enrollment log, protocol deviation log, etc.) should 
be finalized. Additionally, if the study is to be submitted to the Food and Drug 
Administration (FDA) under an Investigational New Drug Application (IND), an 
Investigator's Brochure (for investigational products) or Package Insert (for marketed drugs) 
must be included. The timeline for the development of study materials must be planned for 
and typically takes approximately six months. 
Development of the MOP requires the involvement of the Principal Investigator and study 
staff to ensure that the MOP accurately describes how the study procedures will be 
performed. In multi-site clinical studies, a Steering Committee comprised of the study site 
and coordinating center investigators often finalizes the protocol and develops or oversees 
the development of the MOP.  
The MOP is a dynamic document that will be updated throughout the conduct of a study to 
reflect any protocol or consent amendments as well as the refinement of the CRFs and 
study procedures. The MOP should be maintained in a format that allows it to be easily 
updated and is typically filed in a three-hole binder or kept electronically as a PDF with 
bookmarks for navigation between sections.  For ease of organization, it is recommended 
that the MOP be subdivided into various sections separated by dividers or sheets of color 
paper between each section. Each page of a paper copy of the MOP should have the 
version number and date; electronic versions of the MOP should have consistent naming 
nomenclature that includes version dates. As pages are revised, an updated version 
number and associated date will replace the original page(s) in the MOP. All previous 
versions of the paper and/or electronic versions must be archived. Once approval to begin 
the study is received, any changes to the MOP, including the new version number and 
date, should be submitted to the NIA with track changes for easy reference for review and 
approval before implementation of any modifications.   

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MOP Contents and Organization 
1.0 Introduction 
Regular exercise and lifestyle physical activity (PA) are critical for quality of life and 
longevity among a growing aging population. Aging produces changes to the structure and 
function of the heart, which increases vulnerability to cardiovascular disease (e.g., coronary 
heart disease, heart failure, and stroke), frailty and falls, dementia, and Alzheimer disease. 
Exercise helps to slow the progression of aging-associated changes to the heart by 
promoting adaptations to the cardiovascular and pulmonary system, however exercise 
initiation and maintenance can be difficult in aging adults due to deconditioning, pain, frailty, 
and disability. Cardiac rehabilitation (CR) provides a valuable window-of-opportunity to 
promote exercise and lifestyle PA, and is an ideal way to initiate a new exercise routine, 
particularly in aging adults who would benefit from an individually-tailored exercise 
prescription and supervised exercise to ensure safe uptake and maintenance of PA. 
However, low adherence to CR is common, and lifestyle PA declines with advancing age. 
We have identified exercise anxiety as a novel mechanism related to non-adherence to 
exercise and lifestyle PA, that is driven by cognitive, behavioral, and physiological 
underpinnings. Our preliminary work indicates that exercise anxiety is common among 40-
50% of patients attending outpatient CR and is linked exercise non-engagement. Exercise 
anxiety is particularly elevated in individuals with cardiovascular disease given that the 
physical sensations of exercise often feel like the sensations experienced or attributed to 
cardiovascular disease (e.g., shortness of breath, chest tightness, dizziness, fatigue, pain). 
We developed a mechanism-driven cognitive-behavioral intervention to target exercise 
anxiety, called Behavioral Exposure For Interoceptive Tolerance (BE-FIT). This study aims 
to conduct a Stage II randomized-controlled trial of a novel behavioral intervention, titled 
Behavioral Exposure for Interoceptive Tolerance (BE-FIT), to evaluate (1) its efficacy in 
improving exercise adherence in cardiac rehabilitation (CR) and (2) its mechanisms of 
change. 
The objectives of this study include: 
Objective 1. Compare physical activity outcomes (e.g., lifestyle physical activity levels, 
CR adherence) between participants randomized to receive Behavioral Exposure for 
Interoceptive Tolerance (BE-FIT) intervention or a health education control (HEC).  
Objective 2. Compare exercise anxiety levels between BE-FIT vs. HEC 
Objective 3. Examine the mechanisms by which BE-FIT affects physical activity 
outcomes 
 
 

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2.0 Study Overview 
Title: A tailored exposure intervention targeting exercise anxiety and avoidance in 
cardiac rehabilitation (CR) 
This study is a Stage II randomized-controlled trial of a novel behavioral intervention, 
titled BE-FIT, to evaluate (1) its efficacy in improving exercise adherence in CR and (2) 
its mechanisms of change in individuals 40 years of age and older. One hundred and 
forty-six patients enrolled in Robert Wood Johnson University Hospital (RWJ) CR 
program who have elevated exercise anxiety, as indicated by endorsement of much to 
very much concern about at least 3 items on the Exercise Sensitivity Questionnaire 
(ESQ; Farris et al., 2020) and meet other eligibility criteria will be randomly assigned to 
either receive BE-FIT, a tailored intervention specifically for CR patients with high levels 
of exercise anxiety (n=73), or HEC (n=73), which are matched for contact time. Eligible 
participants will be stratified based on their risk profile (determined by their EHR), age, 
sex, and ESQ score. These stratification variables were selected because they are 
associated with anxiety and fitness levels which could impact PA outcomes. Both 
conditions will be administered by trained doctoral-level students enrolled at Rutgers 
University and will be supervised throughout the course of the study by Dr. Farris and 
other listed co-investigators. 
The BE-FIT intervention is a cognitive-behavioral intervention and is designed to target 
exercise anxiety. The three main components of BE-FIT include: 1) exposure to feared 
bodily sensations and exercise, 2) prevention of safety behavior use before/during/after 
exercise, and 3) use of a wrist-worn activity monitor (Fitbit) for PA feedback and activity 
goal setting. HEC is a time-matched control intervention that will be delivered on the 
same delivery schedule as BE-FIT. The doctoral-level clinicians who will be delivering 
HEC will be exclusively trained in order to avoid contamination with the BE-FIT 
intervention. In this control arm, participants will be provided educational information 
about health topics relevant to healthy aging delivered through PowerPoint lectures and 
handouts and use a Fitbit for PA monitoring. The HEC protocol has been used in prior 
studies conducted by Dr. Abrantes (co-investigator). 
The overall duration of the study is 24 weeks, or approximately 6 months. Subjects will 
be involved in 6 individual sessions delivered twice weekly during the initial weeks of 
outpatient CR. Sessions occur for 45 minutes either immediately before or after 
regularly scheduled CR sessions. Five independent assessments are conducted at 
baseline, EOT, and three follow-ups (Weeks 12, 18, 24). Data collection will occur at 
each visit, with baseline data collected at the initial visit. 
The primary outcome is objectively measured exercised (MVPA mins/day). Secondary 
outcomes are percentage of prescribed CR sessions attended and objectively 
measured lifestyle PA (steps/day). Direct tests of the target mechanisms, exercise 
anxiety and its components (cognitions, safety behaviors, cardiac vagal control), will be 
evaluated to examine target engagement outcomes. 
 

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3.0 Study Organization and Responsibilities 
This section aims to provide a roster of the core study staff and a brief description of 
their roles as well as an organization chart of the full team. An organizational chart is 
provided below for a full scope of the study personnel and the study’s organizational 
scheme. 
On the next page, Table 1 describes and provides a roster of the core investigators and 
primary coordinators of the study team. For each member, a mailing address, phone 
number, email address, and study role are provided.  
 
 

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Table 1: Staff Roster 
Name 
Address 
Phone  
Email  
Role 
Responsibilities 
Samantha 
Farris 
1 Spring Street 
New Brunswick, NJ 
08901 
Telephone: 
(848)445-8843 
 
Fax: (732) 445-
0036 
samantha.farris@r
utgers.edu 
Principal 
investigator 
• Scientific director responsible for 
maintaining scientific and 
procedural integrity 
• Primary management of fiscal and 
administrative items 
• Development and maintenance of 
all study materials (e.g., 
files/records) 
• Reporting and monitoring of 
adverse events 
• Compliance with and 
accountability of study intervention 
administration  
• Submitting documents to 
regulatory bodies (i.e., IRB, NIA) 
• Quality control procedures 
• Ensuring compliance with human 
subjects regulations and policies 
and protecting participants 
• Clinical supervisor and expert in 
cognitive-behavioral and exposure-
based interventions for anxiety 
disorders 
• Working in conjunction with Dr. 
DiBello on the development of the 
randomization scheme and 
procedures 
• Training interventionists on active 
intervention arm 
Teresa 
Leyro 
1 Spring Street 
New Brunswick, NJ 
08901 
Telephone: 
(848) 445-2090 
 
Fax: (732) 445-
0036 
teresa.leyro@rutg
ers.edu 
Co-
Investigator 
• Clinical psychologist and anxiety 
and psychophysiology expert 
• Overseeing psychophysiological 
assessments 
• Leading coordination of data 
scoring/cleaning of 
psychophysiology data with 
statistician 
• Developing and overseeing data 
management procedures including 
the data flow and procedures for 
data entry, error identification and 
correction for all psychophysiology 
data 
• Training interventionists and 
conducting clinical supervision 
Brandon 
Alderman 
607 Allison Road, 
Room 109 
Piscataway, NJ 
08854 
Office:  
(848) 445-9336 
 
Fax:   
(732) 932-9151 
alderman@rutgers
.edu 
Co-
Investigator 
• Exercise physiologist and cardiac 
physiology expert 
• Providing guidance during clinical 
supervision meetings on tailoring 
of exercise and physical activity 
prescription 
• Providing input in investigator 
meetings on physiological 
assessment methods 

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Name 
Address 
Phone  
Email  
Role 
Responsibilities 
• Coordinating data scoring/cleaning 
of psychophysiology data in close 
conjunction with statistician (Dr. 
DiBello) to conduct analyses in the 
later stages of the project 
Angelo 
DiBello 
607 Allison Road, 
Room 213 
Piscataway, NJ 
08854 
Office: 848-445-
2190 
 
Fax: 732-445-
3500 
angelo.dibello@ru
tgers.edu 
Co-
Investigator 
• Study statistician 
• Providing advice on the execution 
of the study, design 
considerations, randomization, and 
conduct primary and secondary 
data analysis and interpretation of 
findings 
• Developing and implementing data 
management procedures including 
the data flow and procedures for 
data entry, error identification and 
correction  
• Enrollment tracking  
Ana 
Abrantes 
Butler Hospital 
345 Blackstone Blvd. 
Providence, RI 02906 
Office: 401-455-
6440 
ana_abrantes@br
own.edu 
Investigator 
• Developing control arm materials  
• Training interventionists and 
conducting clinical supervision  
• Overall support to study design 
and implementation 
• Providing guidance on Fibit usage 
and monitoring data 
Mindy 
Kibbey 
1 Spring Street 
New Brunswick, NJ 
08901 
Office: 732-289-
5036 
mmk192@psych.r
utgers.edu 
Intervention
ist/Study 
Coordinator 
• 
Obtaining informed consent from 
each participant  
• 
Recruitment, screening, and 
enrollment of participants  
• 
Collecting study data and 
following participants through 
study completion 
• 
Overall support to study design 
and implementation 
• 
Maintenance of study binders and 
materials 
• 
Reports - enrollment, participant 
status (e.g., withdrawals), 
adverse events, independent 
safety monitoring body reports 
• 
Study interventionist 
Lilly Derby 
1 Spring Street 
New Brunswick, NJ 
08901 
Office: 732-289-
5036 
ld681@psych.rutg
ers.edu 
Intervention
ist/Study 
Coordinator 
• 
Obtaining informed consent from 
each participant  
• 
Recruitment, screening, and 
enrollment of participants  
• 
Collecting study data and 
following participants through 
study completion 
• 
Overall support to study design 
and implementation 
• 
Maintenance of study binders and 
materials 
• 
Reports - enrollment, participant 
status (e.g., withdrawals), 
adverse events, independent 
safety monitoring body reports  
• 
Study interventionist 

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Name 
Address 
Phone  
Email  
Role 
Responsibilities 
Sayaka 
Carpenter  
1 Spring Street 
New Brunswick, NJ 
08901 
Office: 732-289-
5036 
sc1937@psych.rut
gers.edu 
Study 
Coordinator 
• 
Obtaining informed consent from 
each participant  
• 
Recruitment, screening, and 
enrollment of participants  
• 
Collecting study data and 
following participants through 
study completion 
• 
Overall support to study design 
and implementation 
• 
Maintenance of study binders and 
materials 
• 
Reports - enrollment, participant 
status (e.g., withdrawals), 
adverse events, independent 
safety monitoring body reports  
 
 
 
 

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4.0 Study Flow 
An overview of the study processes is presented in Figure 1 and provides the timing of 
each of the study's major steps.  
Figure 1: Timing of Intervention and Assessment Components 
 
 

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5.0 Informed Consent  
This section of the MOP describes the specific instructions for obtaining informed 
consent. 
• Prior to the eligibility screen, patients that are scheduled to attend the RWJ CR 
Program in New Brunswick (and East Brunswick), NJ will be asked if they are 
interested in participating in a research study following a written script by RWJ 
CR staff. At this time, patients who express interest in participation will verbally 
agree to have their medical records reviewed by study staff in consultation with 
the nursing team.  
• Medical records for these patients will be screened by study staff to assess 
potential eligibility prior to their in-person orientation visit date.  
• At CR orientation, participants who are potentially eligible based on preliminary 
review of medical history will be administered additional screening assessments 
(ESQ, EVS, MoCA). Those who meet all eligibility criteria based on medical 
history and screening assessments will be approached by study staff 
(independent assessor) at their CR orientation visit to introduce themselves to 
the patient and provide detailed information about the study, as well as answer 
any questions.  
• If these patients express interest in participation, study staff will walk through the 
consent details. 
• Study Coordinator (independent assessor) explains risks and benefits, reminding 
patient participation is voluntary, and may discontinue at any time (and procedure 
for termination). 
• Coordinator provides contact information in case of medical emergency due to 
study participation, or for questions about subject rights. 
• Coordinator explains who has access to patient’s protected health information, 
and how confidentiality is maintained. 
• Coordinator explains any costs participation may incur. 
• Coordinator explains how participant may learn outcome of study and be 
provided with a copy of publication of any article published. 
• After discussing the components of the consent form the potential participant can 
ask any remaining questions and then sign the form. When needed, the 
interested participant can take some additional time to look over the consent form 
while at the CR space prior to signing. 
• Copies of signed informed consent form (ICF) will be provided to participant and 
placed in their file. 
• Signed ICF will be stored in a secure locked file box in a locked office.  
5.1 HIPAA Authorization 
In the pre-orientation semi-scripted phone call, the RWJ CR staff member will ask the 
potentially-eligible participant for verbal permission to allow the study team to access 
their protected health information (PHI) prior to or at the beginning of CR orientation. 
Participant information for those who provide verbal assent will only be accessed as 
needed to determine initial eligibility based on their electronic health records and collect 
study-relevant data. This information may include the participant’s name, age, qualifying 

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medical condition, and relevant comorbidities for inclusion into the research study. 
Patients found to be eligible through pre-screen procedures will meet with the study 
coordinator at their CR orientation appointment. The study coordinator (independent 
assessor) will thoroughly present the ICF and explain to the participant that, if they 
choose to enroll in the research study, the study coordinator will collect additional PHI 
for research use in this study and any future uses the participant has agreed to, as 
specified in the consent form.   
 

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6.0 Recruitment and Retention 
6.1 Participant Recruitment 
Potential participants will be recruited at RWJ CR and will be identified through the CR 
program’s record system via consultation with RWJ CR staff. RWJ CR personnel will 
briefly describe the study to patients and interested individuals will consent to study staff 
conducting an eligibility review of their medical records in advance of and/or during the 
CR orientation appointment. Upon orientation at RWJ CR, patients that are potentially 
eligible based on screening assessments will be approached by a member of the study 
team who will introduce themselves to the patient and provide initial information about 
the study. Patients will also receive a study brochure that will include more details about 
the study. If the participant is eligible and interested, the study coordinator will review 
the brochure content and consent form with the potential participant and obtain a written 
signature on the form for patients who consent to study procedures.  
 
6.2 Participant Retention  
Every effort will be made by the PI and study team to ensure participants complete each 
study visit and the study overall. We will use the following strategies to help to maximize 
retention and minimize loss to follow-up: 
• 
Following a proactive plan for retention, including calling participants to see how they are 
doing and to ensure that they can maintain the study protocol.  
• 
Providing a printed timeline/visual aid to remind patient of study appointments and 
calling/texting participants before each session. 
• 
Scheduling sessions to coincide with the CR visits 
• 
Building participant relations and participant satisfaction, with the study coordinator taking a 
central role on this effort e.g., the study coordinator to talk with the participants during their 
established visit schedule to check how they are doing and determine if they are satisfied 
etc.  
• 
Giving participants and their families the opportunity to ask questions and express concerns 
pertaining to their condition throughout the study. 
• 
Obtaining contact information of family/supports to aid in communication and coordination of 
study visits. 
• 
Enhancing participant’s understanding of the study’s objectives and the protocol by 
reminding the participant of the study aim during study visits or having question and answer 
sessions after each visit, if needed. 
• 
Assessing each participant’s drop-out potential.  
• 
Participants will also receive compensation for their participation.  
In the event that a participant does not return for study visits, the PI and/or study 
coordinator will make several contacts using all of the contact information provided by 
the participant.   
 
 

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7.0 Screening and Eligibility Criteria  
7.1 Screening  
The Study Coordinator will utilize the following steps to screen participants for the study: 
I. 
Pre-Screening Phase 
a. Potential participant will be called by a trained RWJ CR staff member to 
schedule their orientation session.  
b. CR staff will explain the study and describe how this involvement is an 
optional adjunct to their normally scheduled CR. If participant is interested, 
the staff member will walk through the consent information to the pre-screen 
procedures (chart review, screening measures).  
c. Verbal agreement to pre-screen procedure will be given during the phone 
conversation by patients who wish to be pre-screened for eligibility. 
II. 
Screening Phase 
a. All screening evaluation to determine eligibility (outlined in Section 7.3) will be 
completed prior to and/or on the day of orientation (review of medical history, 
ESQ, EVS, and MoCA). 
b. Study coordinator will meet with eligible potential participant to explain the 
study. 
c. Study coordinator will probe for participant’s ability to complete the duration of 
the study: 
i. Is the participant planning to move during the duration of the study? 
d. Study coordinator will invite the participant to sign an ICF and provide a copy 
to participant while placing originals in a secure file. 
e. Study coordinator will collect contact information, including contact 
information for two personal contacts. 
7.2 Screening Log 
During the CR orientation screening, a thorough review of medical history, paper 
questionnaires (ESQ, exercise vital sign (EVS)) and Montreal Cognitive Assessment 
(MoCA) will be completed by the nursing staff at RWJ CR in consultation with the study 
research coordinator. The person entering data from screening will be that same study 
research coordinator/independent assessor. All data entry will take place electronically 
using Qualtrics. 
Everyone screened who is eligible will have all their deidentified screening information 
logged in the main Qualtrics survey. Their name, screening date, and screening ID 
number will be entered in a password protected excel file that is kept separate from 
deidentified data. Pertinent information will also be entered in the secure Screening and 
Eligibility Log. 
Those who are screened and deemed ineligible will have their information logged in a 
separate, but parallel Qualtrics survey which includes only screening assessments: 
EVS, ESQ, MoCA, medical history review for eligibility criteria. These ineligible patients 
will have name, screening date, screening ID, primary reason(s) for exclusion kept in a 
separate password-protected excel file. Pertinent information will also be entered in the 
secure Screening and Eligibility Log. 

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The PI will regularly review the excel log of ineligible patients with exclusionary 
information. Based on this, if any changes to screening procedures and/or exclusionary 
criteria are deemed necessary, the paper forms and Qualtrics survey will be modified by 
study staff to reflect those changes, with PI approval. These procedural changes will 
also be reflected in all study documents (e.g., MOP). 
A secure Screening and Eligibility Log documents all individuals evaluated for study 
eligibility. It generally contains the individual’s initials, identification number (screening 
number), age, gender, race, ethnicity, screening date, and eligibility status. (e.g., eligible 
for study participation and date enrolled; ineligible for study participation and reason; 
refused consent and reason). It may also contain the randomization number if different 
from the screening number. 
 
7.3 Eligibility Criteria 
Individuals who are attending CR at RWJ in New Brunswick and East Brunswick who 
provide verbal assent will be screened for study eligibility. Study eligibility is determined 
by the following inclusion/exclusion criteria: 
Inclusion Criteria 
1. ≥ 40 years of age 
2. Elevated exercise anxiety (total score ≥30 or score ≥3 on at least 3 items on ESQ) 
3. Low active (< 90 min self-reported moderate-to-vigorous intensity physical activity/day in 
past three months) 
4. Medically approved for cardiac rehabilitation  
5. English proficiency  
Exclusion Criteria 
1. Evidence of cognitive impairment (< 23 on Montreal Cognitive Assessment; MoCA) 
2. Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-
by-case basis that prevents safe or adequate participation  
3. Expectation that patient will not live through study periods  
If the participant does not meet all the above criteria, he/she will not be eligible for study 
participation. 
 
 

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8.0 Study Intervention  
BE-FIT is a brief, manualized, individual-based intervention specifically designed to 
target exercise anxiety that involves 6 sessions (twice/week) that are ~45 min delivered 
during the first three weeks of outpatient CR, as a supplement to CR. Each session will 
be delivered by a doctoral-level clinician who is exclusively trained to deliver BE-FIT. 
The interventionists will work in tandem with the study exercise physiologist and 
cardiac-technician to coordinate tailoring of BE-FIT content to the patient. BE-FIT 
content includes: (1) Psychoeducation about anxiety/avoidance and values clarification 
and committed action for exercise and lifestyle PA; (2) Graded, repeated exposure to 
bodily sensations and exercise to foster tolerance of discomfort; (3) Fading safety 
behaviors and elimination of exercise avoidance behaviors to build tolerance to 
uncertainty and reduce catastrophizing; and (4) Use of the Fitbit activity tracker to 
facilitate PA monitoring, and to facilitate PA feedback and goal setting. Patients will be 
given a structured workbook that will be used with the interventionist at each session to 
facilitate learning objectives, PA goal setting, and practice. The workbook corresponds 
to session content as follows: Session 1- Psychoeducation & Setting PA Goals; Session 
2- Rationale for Exposure/Fading Safety Behaviors & Developing Exposure Hierarchy; 
Sessions 3, 4, 5- Exposure Practice, Mindful Observing, and Fading Safety Behaviors; 
Session 6- Goal Setting and Planning for Maintenance of Physical Activity. (PA 
monitoring/feedback occurs each session). 
 
The Health Education Control is a time-matched control intervention that will be 
delivered on the same “delivery schedule”. HEC will be delivered by doctoral-level 
clinicians who are trained to exclusively deliver HEC (i.e., these interventionists will be 
different from those delivering BE-FIT to avoid contamination). HEC intervention content 
includes: (1) educational information about health topics relevant to healthy aging, and 
(2) Use of the Fitbit activity watch for PA monitoring. Health information will be 
conveyed through one-on-one interactive lectures and a structured workbook with 
handouts. The following 6 topics will be presented: nutrition, sleep hygiene, how to be a 
smart patient, brain health, emotional health as you age, and living with chronic health 
conditions. The goal of each session will be to provide education, particularly as it 
relates to healthy aging. Patients will be given the same Fitbit as in the BE-FIT but will 
not be given PA goals. Interventionists will routinely address questions related to the 
Fitbit such as syncing issues, charging the battery, and any other technical problems 
that may arise. 
 
All study assessments will be conducted in-person at RWJUH CR. Assessments will be 
completed by an independent evaluator, who will be blinded to aspects of CR treatment 
and study randomization. Patients will be informed to not discuss the nature of their 
treatment with the evaluator to minimize chance of bias and contamination across arms. 

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9.0 Randomization  
After completing 7-days of physical activity monitoring, patients will be randomized to 
either BE-FIT or HEC. The statistician, Dr. DiBello will be responsible for generating 
randomization codes using the following information as blocking variables: 1) age (older 
or equal to 65 years old/younger than 65); 2) sex (female/male); 3) ESQ score 
(above/below 30); 4) risk profile (moderate-high risk/low risk).  
Method: 
1. The statistician will be notified of a new eligible participant by the study coordinator 
1/independent assessor. 
2. The statistician will use an automated computerized log that is separate from the study data 
which will identify the next available code. The statistician will notify the other coordinator 2 
that the code is available.  
3. Coordinator 2 will transfer this code to the screening and enrollment log and notify the 
interventionist that the randomized code is available using a newly assigned study ID 
number for the participant. 
The statistician will maintain the master randomization list, assign randomization codes, 
notify appropriate study staff regarding randomization, and securely store randomization 
files. The study coordinator (not the independent assessor) will initiate randomization 
procedure and must know who to contact once a participant is deemed eligible for the 
study, including which forms to complete prior to randomization. 
 

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10.0 Blinding and Unblinding (Masking and Unmasking) 
All study assessments prior to enrollment, at baseline, and those administered at end-
of-treatment (EOT) and Weeks 12, 18, and 24 will be completed by an independent 
evaluator who will be blinded to aspects of CR treatment and study randomization. 
Patients will be informed to not discuss the nature of their treatment with the evaluator 
to minimize chance of bias.  
 
The study statistician and the interventionists will not be blinded to the randomization or 
the delivered intervention. However, interventionists will either be trained to deliver BE-
FIT or HEC, to limit contamination across interventions.  
Unblinding is a serious action and should be limited to reduce potential bias and 
maintain the integrity of the data. In the event that unblinding occurs, the following 
should be recorded: 
• The ID of the unblinded participant, 
• The reason for unblinding,  
• The study staff person responsible for unblinding 
• A list of person(s) who have been unblinded. 
 
 

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11.0 Study Measurements and Procedures  
All assessments will be conducted in-person at RWJ CR. Data will be collected via 
participant self-reports and Fitbit Charge 5 activity tracker that will be worn by enrolled 
participants, as well as Biopac MP150 System for psychophysiological data collection. All 
study data will be coded with a de-identified study ID number. An independent evaluator 
will collect self-report assessments and psychophysiological data. Graduate-level research 
assistants will administer treatment sessions (BE-FIT or HEC) to participants. Dr. Farris will 
be responsible for overseeing the data collection process. 
 
Demographics. General demographic information including age, sex, race/ethnicity, 
income level and level of education will be collected from medical records and/or at the 
baseline assessment. 
 
Health and Exercise History. Psychological and health history will be evaluated at 
baseline. Medical records will be referenced at baseline to determine eligibility based on 
cardiac diagnosis, medical conditions and medications, and score on Exercise Sensitivity 
Questionnaire (ESQ; see preliminary data). Cognitive ability will be assessed using the 
Montreal Cognitive Assessment (MoCA). The 2-item Exercise Vital Sign will be utilized to 
measure patients’ self-reported exercise levels. Medical records will be accessed again at 
18-Week follow-up to collect data regarding the percentage of subscribed CR sessions that 
were attended. 
 
Exercise Anxiety. The Exercise Sensitivity Questionnaire (ESQ) will be used to measure 
exercise anxiety.  
 
Psychological Functioning. Validated measures commonly used in medical settings to 
screen for common psychiatric conditions (PHQ-9, GAD-7), and a measure of values-
consistent living validated for use in CVD populations (Valuing Questionnaire; VQ), and a 
general index of anxiety sensitivity (Anxiety Sensitivity Index; ASI-3) will be administered. 
 
Anxious Cognitions. Validated report assessment of anxious cognitions will be used to 
tap catastrophizing (Cardiac Anxiety Questionnaire; CAQ and Threat Perceptions), 
intolerance of uncertainty (Intolerance of Uncertainty Scale-Short; IUS-12), discomfort 
intolerance (Discomfort Intolerance Scale; DIS), interoceptive awareness and appraisal 
(Body Vigilance Scale; BVS and Multidimensional Assessment of Interoceptive Awareness; 
MAIA), and fear of falling (Falls Efficacy Scale-International (Short FES-I).  
 
Avoidance/Safety Behaviors. Avoidance behaviors will be assessed via the Safety 
Behaviors Assessment Form (SBAF), Fear of Activity in Coronary Artery Disease (Fact-
CAD), and The Preference for and Tolerance of the Intensity of Exercise Questionnaire 
(PRETIE-Q). 
 
Physical Activity. A Fitbit Charge 5 activity tracker will be used to assess how much 
physical activity participants partake in per day and objective exertion of exercise. A 
number of options exist for goal setting, and we will customize each participant’s account to 
display the following: daily steps, very active minutes, and activity during each hour of the 

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day. While the vast majority of lifestyle PA will consist of walking, Fitbit trackers are 
waterproof and can be worn while swimming. Also, we will provide exchangeable clips to 
allow for trackers to be attached to a sneaker when cycling. In doing so, we likely capture 
all types of lifestyle activities.  
 
For BE-FIT Intervention ONLY: During Session One, the interventionist will review 
baseline PA from the baseline assessment, including daily steps and MVPA. The 
interventionist will use these data to tailor two possible PA prescriptions (goals) – (1) 
Increasing steps/day: If baseline steps/day reflect sedentary/low activity (accumulate 
avg<4,000 steps/day), patients will be given the goal of achieving 4,500 steps/day and 
increasing each session by 500 steps/day (about 1/4 mile increase), as recommended 
by the recent update to PA guidelines. At this rate, patients will reach ~7,500 steps/day 
by EOT, which is an empirically-derived minimum for daily PA in older adults for 
longevity; and/or (2) Increasing PA intensity: If baseline active min/day reflect low MVPA 
(accumulated avg < 30 active mins/day), patients will be given the goal of working 
gradually towards achieving and maintaining 30 very active minutes/day. This gradual 
approach is consistent with implementation of exposure therapy and will ensure that 
patients are not engaging in anxiety-driven avoidance of higher intensity-PA. 
 
Physiological Parameters. To assess cardiac vagal control as a physiological parameter 
of exercise anxiety and a putative BE-FIT target, respiratory sinus arrhythmia (RSA), an 
index of cardiac vagal control will be indexed at baseline, end-of-treatment, and week 12 
follow-ups. At each time point, we will specifically assess cardiac vagal control during a 5-
minute resting period (i.e., tonic) and cardiac vagal reactivity during a 5-minute attentional 
demand (i.e., phasic changes in RSA), which has previously been used to assess acute 
changes in cardiac vagal control as an index of psychological flexibility and vulnerability. 
We will also assess heart rate deceleration (event-related potential) in response to a 5-min 
Stroop task. Continuous measures of electrocardiograph (ECG), impedance cardiograph 
(IC), and blood pressure (BP) will be acquired at 1000 Hz using a Biopac MP150 and an 
integrated CNAP blood pressure monitor. Signals will be scored and offline in 1-minute bins 
in accordance with recommendations of the Society for Psychophysiological Research 
using MindWare’s integrated system (BioNex 8SLT Biolab Acquisition Application, 
MindWare Technologies, Gahanna OH). RSA will be specified as the integral power within 
typical adult respiration frequency (.12 to .4 Hz), and respiration rate will be derived from 
IC. Reactivity will be computed by subtracting baseline scores from the attentional demand 
scores; because RSA decreases during attentional demand, lower numbers for vagal 
reactivity represent greater reactivity. Cardiac output will be calculated with the Kubicek 
formula to provide an estimate of the amount of blood processed by the heart in 1 min. The 
pre-ejection period will be measured as the time in ms from the onset of ventricular 
depolarization to the aortic valve opening. Continuous assessment of BP will allow scoring 
of the baroreceptor reflex, defined as changes in the interbeat interval per unit change in 
BP (ms/mmHG), a supplemental index of vagal control. Use of beta blockers will be used 
as a covariate when interpreting parameters given its physiological effects. 
 

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11.1 Timeline and assessment schedule 
Study visit schedule with assessments table below:   
Assessment 
Screen/
BL 
Treatment 
Visit: Week 
1 
Treatment 
Visit Week 
2 
Treatment 
Visit Week 
3 
Treatment 
Visit Week 
4 
EOT 
Week 
6 
Follow-
up 
Week 
12 
Follow-
up 
Week 
18 
Follow-
up 
Week 
24 
Exercise Vital Sign 
X 
 
 
 
 
 
 
 
 
Cardiac/Medical History  
X 
 
 
 
 
 
 
 
 
ESQ 
X 
 
 
 
 
X 
X 
X 
X 
MoCA 
X 
 
 
 
 
 
 
 
 
Eligibility/Randomization 
X 
 
 
 
 
 
 
 
 
Informed Consent Form 
X 
 
 
 
 
 
 
 
 
MVPA minutes/day; 
steps/day 
X 
X 
X 
X 
X 
X 
X 
X 
X 
# CR attendance 
 
 
 
 
 
 
 
X 
 
CAQ 
X 
 
 
 
 
X 
X 
X 
X 
IUS-12 
X 
 
 
 
 
X 
X 
X 
X 
ASI-3 
X 
 
 
 
 
X 
X 
X 
X 
DIS-R 
X 
 
 
 
 
X 
X 
X 
X 
SBAF 
X 
 
 
 
 
X 
X 
X 
X 
Fact-CAD 
X 
 
 
 
 
X 
X 
X 
X 
PRETIE-Q 
X 
 
 
 
 
X 
X 
X 
X 
Threat Perceptions 
X 
 
 
 
 
X 
X 
X 
X 
VQ 
X 
 
 
 
 
X 
X 
X 
X 
FES-I 
X 
 
 
 
 
X 
X 
X 
X 
BVS 
X 
 
 
 
 
X 
X 
X 
X 
MAIA 
X 
 
 
 
 
X 
X 
X 
X 
GAD-7 
X 
 
 
 
 
X 
X 
X 
X 
PHQ-9 
X 
 
 
 
 
X 
X 
X 
X 
Vagal Flexibility and 
tone 
X 
 
 
 
 
X 
X 
 
 
Respiration Rate, HR, 
Baroreceptor Reflex 
X 
 
 
 
 
X 
X 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 

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11.2 Visit Procedures 
Enrollment. The enrollment date is day the individual has met all the screening criteria and 
signs the informed consent form (CR orientation day). 
Baseline. During CR orientation, patients will be provided with the Fitbit, shown how to 
wear, charge, and sync it. Patients will be required to wear the Fitbit for at least 7 
consecutive days for 10+hrs/day to establish baseline PA activity prior to randomization. 
For participants who have successfully been screened for eligibility and are enrolled into 
the study, paper-copy baseline self-report questionnaires and psychophysiological 
assessments are administered by the study coordinator. After completing the assessments, 
the coordinator will remind the participant of their next scheduled visit, and re-check the 
participant’s contact information for accuracy. All self-report data collected during this 
session will be reported on Qualtrics. Psychophysiological data (heart rate and blood 
pressure) will be recorded via Biopac AcqKnowledge. After this session has ended, 
participant is free to leave.  
Sessions 1-6. Each intervention session will occur either before or after CR and will last for 
45-minutes. Depending on the sequence of when the session will take place (either before 
or after CR), interventionists will greet the participant in the waiting area of the CR space. 
Together they will walk to a semi-private location to begin the session. Once the session 
has been completed, the interventionist will ask if the participant has any questions and 
remind them of their next appointment and homework. Once discussion has been 
completed, the interventionist will walk the participant out to the door or to their CR class. 
End-of-Treatment. This visit will similarly take place either before or after the participant’s 
CR appointment. However, no intervention will be delivered during this meeting. During this 
session, participants will complete self-report measures and physiological assessments 
conducted by the independent assessor. Once all assessments have been completed, the 
independent assessor will ask if the participant has any questions and remind of their next 
appointment at week 12 (final day of CR). The participant and the assessor will conclude 
the session and walk the participant out to the door or to their CR class. 
11.3 Follow-up 
Participants will be followed through all study visits through the study completion. Follow-up 
appointments will take place at weeks 12 (final CR session), 18, and 24. Similar to the end-
of-treatment session, the independent assessor will meet with the participant at RWJ CR to 
complete self-report and physiological assessments (only week 12). Week 12 follow-up 
(follow-up 1) will last for 1 hour. The subsequent two follow-ups should take around 20-30 
minutes.  
We will use the following strategies when meeting with and following the participants: 
• Regular phone calls and/or to ensure Fitbit compliance 
• Answer any questions or concerns the participant may have 
 
11.4 Final Study/Early Discontinuation Evaluations 
In the event a participant discontinues study treatment before study completion, every effort 
will be made by the study team to have the participant continue to complete all other study 

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procedures until end-of-treatment/follow-up. However, if the participant is not willing to 
continue study participation, the study team will attempt to collect the final visit data.  
Extenuating circumstances due to unexpected illness/injury, insurance difficulties, travel, 
etc. may also result in intervention discontinuation or temporary delay. Modifications to the 
schedule and the duration of continued follow-up will be determined on a case-by-case 
basis for the completion of the study procedures. If applicable, outcomes may continue to 
be followed.  
Subjects may withdraw voluntarily from participation in the study at any time and for any 
reason. Participants should continue to be followed, with their permission, even if the study 
intervention is discontinued. If participants discontinue early, a new participant will be 
enrolled into the study to complete the protocol. 
The intervention may be discontinued at any time by the IRB, the NIA, or other government 
agencies as part of their duties to ensure that research participants are protected. 
12.0 Concomitant Medications 
The following includes all the medications that are prohibited during the course of the study: 
§ 
None 
*Note: all treatment as usual as prescribed by medical professionals is allowed throughout the study 
duration 
13.0 Safety Reporting 
Adverse Event (AE) and Serious Adverse Event (SAE) definitions: 
• Adverse Event – Any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (e.g. abnormal physical exam or laboratory 
finding), symptom (e.g. dizziness or shortness of breath), or disease (CVD event), 
temporally associated with the subject’s participation in the research, whether or not 
considered related to the subject’s participation in the research. 
• Serious Adverse Event – A serious adverse event is any untoward medical 
occurrence that results in death, is life-threatening, requires or prolongs hospitalization, 
causes persistent or significant disability/incapacity, results in congenital 
anomalies/birth defects, or, in the opinion of the investigators, represents other 
significant hazards or potentially serious harm to research participants or others. 
13.1 Adverse Event Reporting 
All AEs and SAEs will be collected and documented starting once the participant has 
consented to participating in the study through the end of the study. At each visit, study 
staff will specifically query participants for adverse events. Upon notification of an Adverse 
Event (AE), the study coordinator will notify all appropriate parties as described in the 
protocol: 
1. The study coordinator and/or interventionist will complete the AE form as it exists in 
Appendix F. 

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2. The study coordinator and/or interventionist will immediately notify the PI and medical 
monitor at CR. 
a. The event will be reviewed by the PI upon notification and determine the severity of 
the event. 
3. All reports will detail whether the event was expected or unexpected, a rating of severity of 
the event, a brief narrative summary of the event, a determination of whether a causal 
relationship existed between the study procedures and the event, and whether informed 
consent should be changed because of the event. 
4. The PI will advise the Study Team regarding screening, enrollment, and ongoing 
participation. 
5. Upon advisement by the IRB, the PI will determine the study’s status, and notify the Study 
Team. 
6. Adverse events will be followed until resolution, stabilization, or until it is determined that the 
study participation is not the cause. 
7. All events will be tracked and reported throughout the study.  
 
13.2 Unanticipated Problems 
In addition to regular monitoring and reporting of adverse events, study staff will be fully 
trained in the OHRP definitions of adverse events that are also unanticipated problems; 
serious adverse events; or unanticipated problems that are not adverse events. In the case 
of any of those events, study staff are required to report that information to the PI 
immediately both verbally and in writing. When necessary, a report of a serious adverse 
event will result in the PI contacting the participant to further assess the event. In all cases, 
Dr. Farris will determine if a follow-up to an experienced SAE/AE or unanticipated problem 
is necessary. When deemed so, Dr. Farris will be in contact with the research participant 
and/or their treating providers to facilitate information transfer (with the participant’s 
consent) and coordinate care as needed. 
Upon notification of an Unanticipated Problem, the study coordinator will notify all 
appropriate parties as described in the protocol: 
1. The study coordinator and/or interventionist will notify the Principal Investigator and Medical 
Monitor at CR immediately. 
2. The PI will review the details of the event 
3. When necessary, the coordinator will draft a notification email to the SO (and IRB, if 
needed). The coordinator will review and submit the draft notification to the PI. 
4. The PI will advise the Study Team regarding screening, enrollment, and ongoing 
participation. 
5. Upon advisement by the SO and/or the IRB, the Principal Investigator will determine the 
study’s status and notify the Study Team. 
 
13.3 Serious Adverse Event Reporting 
Consistent with NIH guidelines and OHRP policy, serious adverse events (SAEs) are 
adverse events that meet any of the following criteria: fatal or life-threatening, result in 
significant or persistent disability, require or prolong hospitalization, result in a congenital 

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anomaly/birth defect, or are important medical events that investigators judge to represent 
significant hazards or harm to research subjects. Any adverse event that meets any of 
these criteria (e.g. results in hospitalization) will be documented and reported as a SAE.  
Upon notification of a Serious Adverse Event (SAE), the study coordinator will notify all 
appropriate parties as described in the protocol: 
1. The SAE form (Appendix G) will be completed by study investigators with the help of the 
participant who can provide information about the event.  
2. The study coordinator will immediately notify the PI and Medical Monitor at CR. 
3. A written letter detailing the nature of the event will be drafted by the study coordinator and/or 
interventionist and be sent to the PI.  
4. SAEs that are unexpected (e.g., serious medical event during intervention session or prescribed 
activities, suicide attempt within study period) are unlikely but will be reported to the NIA PO (Dr. 
Lisa Onken) and the SO (Dr. Mazzulla) via written report within 48 hours of becoming aware of 
the SAE, and to the IRB per their reporting requirements. All deaths of patients actively enrolled 
in the study will be reported within 24 hours of study’s knowledge of death to the NIA PO, Dr. 
Mazzulla, and the IRB.  
5. A summary of all other SAEs (i.e., expected) will be reported to the NIA PO and Dr. Mazzulla in 
regular quarterly reports. Given the age and medical comorbidities of patients enrolled in this 
study, non-study-related medical events and hospitalizations may be expected to occur during 
the period of study enrollment and follow-up assessment. These events, when deemed 
unrelated to study participation (i.e., not a direct result of intervention activities or study 
assessment procedures) will be included in adverse event documentation and reporting at 
regular quarterly intervals.  
6. All SAEs will be reviewed by the full committee of the Rutgers University IRB. 
7. The PI will advise the Study Team regarding screening, enrollment, and ongoing participation. 
8. Upon advisement by the IRB, the Principal Investigator will determine the study’s status, and 
notify the Study Team. 
14.0 Study Compliance  
All other deviations will be reported routinely to the independent safety monitoring body. 
The study coordinator will maintain a log of all protocol deviations.  
Protocol deviations/violations, include, but are not limited to, the following: 
• 
Enrollment or randomization of an ineligible participant 
• 
Failure to obtain Informed Consent 
• 
Visits or procedures conducted outside of the protocol specified window  
• 
Failure to keep IRB approval up-to-date 
• 
Wrong treatment administered to participant 
• 
Follow-up visit at a time point different from that specified in the protocol 
The study site will maintain a log of all protocol deviations/violations and should report them 
as specified in the DSMP to the safety monitoring committee. A log is presented in 
Appendix B. Please note, only protocol deviations that impact participant safety should be 
reported within 24 hours of occurrence if possible, or as soon as they are discovered. 

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15.0 Data Collection and Study Forms 
The following documents are used in this study for initial screening and data collection. 
See Appendix E. 
All incomplete forms are saved on a shared drive that can be accessed by study 
personnel. Prior versions will be stored in an “archive” folder. Any updates needed for 
study forms and assessments will be completed by the study team and approved by the 
PI. All study questionnaires will be delivered to the patient as a paper copy (organized in 
preparation for study visit by study personnel) and will then be entered into Qualtrics by 
a study coordinator. 
1. Medical History & CR Attendance 
a. Medical Data Extraction Form. Relevant medical history collected at screening; CR 
attendance collected at F2. 
2.  Exercise Questionnaires 
a. Exercise Vital Signs (EVS). Assessed at screening 
b. Exercise Sensations Questionnaire (ESQ). Assessed at screening, EOT, F1, F2, F3.  
c. Fear of Activity in Patients with Coronary Artery Disease (Fact-CAD). Assessed at 
BL, EOT, F1, F2, F3. 
d. Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q). 
Assessed at BL, EOT, F1, F2, F3. 
3. Psychological Factors 
a. Montreal Cognitive Assessment (MOCA). Delivered at screening. 
b. Cardiac Anxiety Questionnaire (CAQ). Assessed at BL, EOT, F1, F2, F3. 
c. Safety Behaviors Assessment Form (SBAF). Assessed at BL, EOT, F1, F2, F3. 
d. Threat Perceptions. Assessed at BL, EOT, F1, F2, F3. 
e. Valuing Questionnaire (VQ). Assessed at BL, EOT, F1, F2, F3. 
f. Intolerance of Uncertainty Scale Short Form (IUS-12). Assessed at BL, EOT, F1, F2, 
F3. 
g. Falls Efficacy Scale-International (Short FES-I). Assessed at BL, EOT, F1, F2, F3. 
h. Discomfort Intolerance Scale (DIS-R). Assessed at BL, EOT, F1, F2, F3. 
i. 
Body Vigilance Scale (BVS). Assessed at BL, EOT, F1, F2, F3. 
j. 
Multidimensional Assessment of Interoceptive Awareness (MAIA). Assessed at BL, 
EOT, F1, F2, F3. 
k. Anxiety Sensitivity Index (ASI-3). Assessed at BL, EOT, F1, F2, F3. 
l. 
General Anxiety Disorder 7-Item Scale (GAD-7). Assessed at BL, EOT, F1, F2, F3. 
m. Patient Health Questionnaire-9 (PHQ-9). Assessed at BL, EOT, F1, F2, F3. 
In addition, Fitbit data will be downloaded from the participant devices using appropriate 
software. Fitbit data is identified only with a randomly generated study ID. Fitbits will be 
worn throughout the study duration. 
Physiological data will be collected at BL, EOT, and F1 to assess: 5-min average RSA, 
5-min attentional demand, and 5-min Stroop task. Respiration rate, heart rate, and 
baroceptor reflex will also be measured. For data collection, participants will be hooked 
up to Biopac’s integrated psychophysiological system (MP150) and an integrated CNAP 

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blood pressure monitor to obtain continuous non-invasive measures of blood pressure, 
electrocardiograph (ECG), and impedance cardiograph (IC), which allows for the 
extraction of respiration data. This will require placing three passive spot electrodes to 
the chest area to index electrocardiogram, and four passive spot electrodes to the neck 
and chest region to measure cardiac impedance and respiration. In addition, 
participants will be attached to arm and finger cuffs to index blood pressure. Four five-
minute segments will be scored using MindWare.  
15.1 Source Documentation 
The source documentation used in this study will include the medical data obtained prior 
to enrollment to determine eligibility for participation. All medical data will be reviewed 
along with a medical staff member at RWJ CR.  
 
In addition, all signed consent forms with identifying information from the participants 
will be filed in a locked study file, separate from any de-identified information pertaining 
to the participant (e.g., paper versions of administered assessments).  
 
At conclusion of the study, all forms will be kept with the study records based on the 
requirements of the IRB guidelines.  
15.2 General Instructions for Completing Forms  
Print using black or blue ink when completing study forms. Note, participants must not be 
identified by name on any study document submitted with the forms. Replace the 
participant’s name with the participant identification (ID) number.  
§ Header:  Complete the header information on EVERY page, including pages for 
which no study data are recorded.  
§ Participant ID:  The participant ID must be recorded on EVERY page, including 
pages for which no study data are recorded. 
§ Dates: All dates must be recorded on the date of form completion. 
§ Study timeline must also be recorded on the form. 
§ Extraneous Writing: Comments written extraneously on forms cannot be 
captured in the database; thus, write only in the spaces indicated.   
§ Correcting errors:  If an error has been made on the study forms, place a single 
line through the erroneous entry and record the date and your initials. Indicate 
the correct response. 
§ Skipping items: Do not skip any items. Some items may carry "Unknown" or 
"Not Applicable" response choices which should be checked when necessary.  
§ Incomplete data: Data may not be available to complete the form for various 
reasons.  Circle the item for which data is not available and indicate the reason 
near the appropriate field: 
§ 
If an evaluation was not done, write ND and provide a reason. 
§ 
If the information is not available, but the evaluation was done, write 
NAV.   
Note:  Only in rare circumstances, as in the case of lost 
documentation, should NAV be recorded on the form.  Every effort 
should be made to obtain the information requested. 

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§ If an evaluation is not applicable, write NA. 
§ 
Incomplete or Illegible forms: Incomplete forms that do not have adequate 
explanation (as described above) compromise the integrity of the entire 
study. 
15.3 Data Flow  
Data will be collected via participant self-reports, Biopac psychophysiological data 
acquisition, and Fitbit Charge 5 activity trackers that will be worn by enrolled 
participants. All collected data will be de-identified throughout the study. An independent 
evaluator will collect self-report and psychophysiological assessments. Graduate-level 
research assistants will administer the treatment sessions (BE-FIT or HEC) to 
participants. Dr. Farris will be responsible for overseeing the data collection process. 
All forms will be completed with the participants to ensure that all information is 
complete, intact, and transmitted into Qualtrics. All data uploaded onto Qualtrics will be 
monitored weekly by the study statistician and study personnel.  
Any errors identified during this data check will be documented and an attempt to 
correct any errors will be made. 
15.4 Administrative Forms 
 
Administrative forms provide documentation of study processes and assist with study 
operations (e.g., screening log). In this section of the MOP, listed below are the study 
forms that will be used.  
• 
Screening and Enrollment Log - Used to list participants screened; includes those 
who fail screening and those who are enrolled. 
• 
Participant Identification Code List 
• 
Interventionist Manual 
• 
Study Administration Checklist 
15.5 Retention of Study Documentation  
After the study ends, study staff shall maintain participant forms in a secure location at 
Rutgers University in New Brunswick, NJ, USA for 6 years, as indicated by the protocol 
and IRB guidance.  
 
16.0 Data Management 
All study-generated self-report measures are compiled in standardized formats and 
reviewed for ease of reading to minimize missing data. Data will first be data entered into 
Qualtrics by a coordinator and then checked by a senior research assistant in a blind 
verification of the original entry. A program will run to flag discrepancies. Discrepancies will 
be reconciled directly with original assessment by the PI and Dr. DiBello, who will make 
final decisions about data coding. Data will be downloaded and backed-up on the Rutgers 
University secure network weekly. RWJ CR will support data management from their 
medical records and will coordinate data extraction from screening as needed. We will 
implement regular cleaning routines that will be used on hand-entered data in order to 

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identify miscoded or duplicate variables, mismatched admission/discharges dates, and out 
of range values. Documents containing identifying and personal information of study 
patients are kept entirely separate from their coded data. 
 
All data collected by the research team are considered part of the subject’s confidential 
record. There are several sources of data. In most cases, data from assessments will be 
first written on paper and then entered into the research database.  
 
Physiological data will be collected at BL, EOT, and F1. Data will be collected via Biopac’s 
integrated psychophysiological system (MP150) to obtain continuous non-invasive 
measures of blood pressure, electrocardiograph (ECG) and impedance cardiograph (IC), 
which allows for the extraction of respiration data. This will require placing three passive 
spot electrodes to the chest area to index electrocardiogram, and four passive spot 
electrodes to the neck and chest region to measure cardiac impedance and respiration. In 
addition, participants will be attached to arm and finger cuffs to continuously index blood 
pressure. Four five-minute segments will be scored using Mindware. Dr. Leyro will oversee 
data scoring.  
 
Fitbit data will be downloaded from the devices using appropriate software. Fitbit data is 
identified only with a randomly generated study ID.  
 
Audio recordings of intervention sessions will be uploaded and stored on a secure server in 
a digital format. A study ID will be used to identify the recordings. Otherwise, they are not 
connected with the primary study database in any way. In addition, all patients in the study 
will be provided with a Google Gmail account to activate their Fitbit. A standardized account 
name and password without identifying information (e.g., absent of name, initials, date of 
birth, exc.) will be established for each patient by a member of the research team. The 
account log and password list will be linked with the patient research identification number 
but will not contain PHI information. The Gmail account will be shared by the research 
interventionist, who will be able to access the patient’ Fitbit activity data for purposes of the 
proposed intervention. Google services and data centers protect data with multiple layers of 
security, including leading encryption technology like HTTPS. The study Gmail accounts 
will be used to establish and sync Fitbit accounts only and not for study-related or any other 
communication purposes. 
16.1 Quality Control Procedures  
At the outset of the study, Dr. Farris and Dr. DiBello (biostatistician) will review the 
incoming data to assess adequacy for analytic purposes (not to evaluate study outcomes). 
As the study progresses, Dr. DiBello will continue to monitor the data. These practices 
ensure data quality so that the primary aims of the study will be met. Given that the 
independent evaluators will be blinded to outcomes during data collection and will not share 
results with any study staff who may interact with participants, the risk of these procedures 
incurring experimenter bias is low. 
16.1.1 Standard Operating Procedures 
Data are monitored on an ongoing basis to produce a number of standard reports that are 
made available to the study PI automatically as data tables are populated. Additional 

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reports can be created as requested. Most reports display data such as recruitment reports 
comparing goal versus actual recruitment; participant retention reports indicating the 
number of participants attending each assessment visit, etc. Monitoring reports will also be 
presented to the DSMC along with outcomes and safety data. 
16.1.2 Data and Form Checks 
Data and form checks will occur weekly/bi-weekly by the study statistician, PI, Dr. Leyro, 
and study personnel. Additionally, computer programming will run to flag any 
discrepancies. Data quality control checks may identify potential data anomalies such as:  
• 
Missing data or forms  
• 
Out-of-range or erroneous data 
• 
Inconsistent and illogical dates over time  
• 
Data inconsistency across forms and visits 
• 
Not completing all fields of a "completed form" or no reason for missing data is 
provided  
16.1.3 Site Monitoring 
Site monitoring may take place through periodic site visits conducted during the study. The 
frequency of visits may depend upon the site's performance and the number of participants 
enrolled.  
The purposes of monitoring visits are to: 
• Ensure the rights and safety of participants 
• Confirm that the study is conducted in accordance with GCP guidelines 
• Ensure maintenance of required documents 
 
• Verify adherence to the protocol 
• Monitor the quality of data collected 
• Ensure accurate reporting and documentation of all AEs and unanticipated 
problems 
During monitoring visits, the recorded data are reviewed and verified against source 
documents to ensure: 
• Informed consent has been obtained and documented in accordance with IRB 
regulations 
• The information recorded on the forms is complete and accurate 
• There are no omissions in the reports of specific data elements 
• Missing examinations are indicated on the forms 
• Participant disposition when exiting the study is accurately recorded 
In preparation for monitoring, the monitor has access to all study documents, including 
informed consent forms, intervention records, and assessments as provided by the PI. 
Once the site visit is complete, a site monitoring report is drafted to provide feedback 
regarding any problems or issues that may have been uncovered during the visit. The 
report should state the problems uncovered during the visit and describe recommendations 
to correct them. A timeline will be agreed upon and included in the report to ensure that the 

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follow-up of the issues is completed and implemented into the study’s procedures. 
17.0 Data and Safety Monitoring Activities 
The data safety monitoring plan (DSMP) for this study focuses primarily on monitoring of 
study progress by the principal investigator in conjunction with the local data/safety 
committee, led by the medical SO. Note: This is a single-site, low risk study, thus we are 
NOT proposing to use a Data and Safety Monitoring Board. Study procedures for 
monitoring recruitment, data collection, data quality and data management/confidentiality 
have been outlined below. All reports will be compiled by Dr. Farris and will be circulated to 
the IRB and the sponsor. Measures to maintain participant privacy and security will be 
implemented.   
Data and Safety Monitoring Committee 
Oversight of the participants’ safety and quality of data will be conducted by the PI, Dr. 
Farris, along with our monitoring committee composed of external faculty outside of the 
Rutgers University IRB. Committee members: 
Francesca Mazzulla, MD (Chair/Safety Officer), Cardiologist at Columbia St. Mary's 
Cardiovascular Specialists 
Joshua Kemp, PhD (Member), Clinical Psychologist at Bradley Hospital/Brown 
Medical School 
Lauren Connell Bohlen, PhD (Member), Behavioral Scientist at Brown School of 
Public Health  
The committee will review rates of adverse events to determine any changes in participant 
risk, recruitment and retention, participant drop out, and will make appropriate 
recommendations for changes in protocol. Any changes in the protocol will be submitted to 
the Rutgers University IRB for review. 
17.1 Reports 
Every six months, study personnel and PI will submit tables indicating progress with 
recruitment, retention at assessment sessions, and reasons for dropouts to the committee 
for review. IRB compliance will be reviewed annually by the committee. They will meet 
twice annually, either in-person or by teleconference, to consider whether corrective action, 
or a change to protocol is required and if so, report that in writing to the PI, the Rutgers IRB 
responsible for oversight of this trial, and the NIH sponsor. At any point during the trial, the 
committee can recommend that a meeting be held to discuss any issues with the progress 
or safety of the trial. The committee members will also be available to meet outside of the 
biannual meetings, if necessary, to discuss concerns regarding a particular participant or 
research problem. 
The SO, Dr. Mazzulla, will receive quarterly reports of expected SAEs and will be informed 
of unexpected SAEs and deaths of actively enrolled participants within 48 and 24 hours, 
respectively. These reports will be synthesized together with all other adverse events into 
biannual reports including a detailed analysis of study progress, data and safety issues, 
which will be submitted for review by Dr. Mazzulla and Safety Monitoring Committee 
members and also reported to the IRB according to their procedures. 

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17.2 Study Completion and Close-Out Procedures  
Study close-out activities will be performed to confirm that the site investigator’s study 
obligations have been met and post-study obligations are understood.  
Close-out activities include, but are not limited to, the following: 
• 
Verification that study procedures have been completed, data have been 
collected, and study intervention(s) and supplies are returned to the responsible 
party or prepared for destruction.  
• 
Assurance that all data queries have been completed. 
• 
Assurance that correspondence and study files are accessible for external 
audits. 
• 
Assurance that the study records are maintained and any relevant study 
information reported to the NIA.  
• 
Assurance that the investigator will notify the IRB of the study’s completion and 
store a copy of the notification. 
• 
Preparation of a report summarizing the study’s conduct. 
• 
Participant notification of the study completion. 
Additional close-out activities can be found in Appendix H. 
17.2.1 Participant Notification 
The PI and study staff will notify participants that the study is over at their 3rd follow-up visit 
(week 24). Participants will be asked whether they would like to be informed of the results 
and then will thank them for their participation.  
17.2.2 Confidentiality Procedures 
All data will be collected for research purposes only and all records will be stored in locked 
files (physical or on computer) in locked rooms accessible only to research staff. Data 
gathered from people who are screened but who do not meet inclusion criteria or decide 
not to participate will be stripped of personal identifiers or links and only demographic 
characteristics and the reason for study exclusion will be kept. Paper forms with personal 
identifiers (such as consent forms or contact information) will be stored in a locked file that 
does not contain subject code numbers. All other data will be stored in files locked in a 
separate location with only code numbers identifying subjects, no personal identifiers. A 
cross-index of code numbers and participant names will be kept in a separate, password-
protected computer file that is available only to research staff (for collecting follow-ups), the 
PI, and mandated auditing agencies during audits. All de-identified research data will be 
entered into Qualtrics, a secure, web application designed to support data capture for 
research studies, providing user-friendly web-based case report forms, real-time data entry 
validation (e.g., for data types and range checks) and a de-identified data export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). Network 
transmissions (data entry, survey submission, web browsing, etc.) in Qualtrics are 
protected via Secure Sockets Layer (SSL) encryption. Access to Qualtrics databases can 
be restricted to specific study personnel. Exported data from Qualtrics will be stored on the 
Rutgers University secure password-protected server. Multiple redundant backup systems 

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are in place to ensure security of data storage. In addition, we ensure local confidentiality 
by requiring rotating password access to client machines and password protected access 
to database clients. Only the participants’ study identification number will appear on any of 
the final paper data collection instruments. Once data have been entered and passed audit 
verification, paper copies of data will be housed at a facility that specializes in the storage 
of medical/research information. Only the subject's study identification number will be 
present on the forms. Any indication of the subject's name will be removed from the 
questionnaires prior to its archiving. The destruction date of these paper files will be at least 
7 years from the termination of the study and will be authorized by the PI of the research 
study. 
The following is a list of study participant confidentiality safeguards: 
• 
Electronic files – Data identifying participants that are stored electronically 
should be maintained in an encrypted form or in a separate file. 
• 
Forms – Forms or pages containing personal identifying information should be 
separated from other pages of the data forms and retained in a secure location.  
• 
Data listings – Participant name, name code, hospital chart, record number, 
Social Security Number, or other unique identifiers should not be included in 
any published data listing. 
• 
Data distribution – Data listings that contain participant name, name code, or 
other identifiers easily associated with a specific participant should not be 
distributed. 
• 
Data disposal – Computer listings that contain participant-identifying 
information should be disposed of in an appropriate manner. 
• 
Access – Participant records should not be accessible to persons outside the 
site without the express written consent of the participant. 
• 
Storage – Study forms and related documents retained both during and after 
study completion should be stored in a secure location 
• 
Passwords – Passwords provide limitations on general access to computer 
systems and to the functions that individuals can use.  Passwords should be 
changed on a regular basis. 
• 
User Training – Study staff with access to clinical computer systems should be 
trained in their use and in related security measures.  Training should include 
explanations of how to access the system and a discussion of the need for, and 
importance of, system security.  
• 
System Testing – Prior to the use of a new computer system, and after any 
modifications, the system should be tested to verify that it performs as 
expected. Testing should verify that the password-activated access system 
performs as intended. 
• 
System Backups – Backup copies of electronic data should be made at 
specified intervals. Backups should be stored in file cabinets or secure areas 
with limited access. Storage areas should have controlled temperature (i.e., 
approximately 68°F (20°C)) and relative humidity (i.e., 50%) so that backup 
tapes are not damaged. 

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17.2.3 Publications 
Rutgers University is committed to the open and timely dissemination of outcomes and 
useful information that stems from the proposed research. Similarly, Dr. Farris 
recognizes that the innovative treatment methods used in this project may have 
potential for future widespread clinical utility and agree to comply with the requirements, 
guidelines, and principles described by NIH in NOT-OD-16-149 “NIH Policy on 
Dissemination of NIH-Funded Clinical Trial Information” for and “NIH Sharing Policies 
and Related Guidance on NIH-funded Research Resources.” Dr. Farris will ensure 
compliance with the requirements. She will register the study on ClinicalTrials.gov no 
later than the beginning of month 6 of Project Year 1 or one month before the first study 
participant is enrolled. The record will include all required content including study 
description details, recruitment status, location and contact information, and 
administrative data. The informed consent documents for the study will include a 
statement that information about the study will be available on clinicaltrials.gov. Study 
results will be added to the clinicaltrials.gov study record no later than the end of the 
project period (anticipated to occur at Year 5, month 12). Rutgers University has an 
internal policy in place via the Office of Sponsored Research to ensure that the clinical 
trials registration and results reporting occur in compliance with NIH policy 
requirements. Data generated by this study will be presented at national and 
international conferences.  Results pertaining to study aims will be published no later 
than 1 year after the end of the project period. All final peer-reviewed manuscripts will 
be submitted to the digital archive PubMed Central. Also, whenever possible, data will 
be deposited to appropriate public repositories. Personnel effort, equipment, and other 
resources necessary to achieve full compliance with requirements for dissemination are 
included in the study budget.    
 
18.0 MOP Maintenance 
The MOP will be continuously reviewed by the study staff to ensure that the operating 
procedures described are accurate. If any procedures have been changed or modified, 
the MOP should be updated, and the revised document distributed, with instructions, for 
replacement in the MOP.  See Appendix D.  
 
 
 
 

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Appendix A - Protocol  
 
 
 
INTERVENTIONAL 
RESEARCH PROTOCOL TEMPLATE 
(HRP-503a) 
 
 
 
 
STUDY INFORMATION 
 
§ 
Title of Project: A Tailored Exposure Intervention for Exercise Anxiety and Avoidance 
in Cardiac Rehabilitation 
 
§ 
Principal Investigator Name: Samantha Farris, PhD 
 
§ 
Principal Investigator Div. & Dept.: Department of Psychology, SAS 
 
§ 
Principal Investigator Contact Info:  
Email: samantha.farris@rutgers.edu 
Work Address: 1 Spring Street, New Brunswick, NJ 08901 
Work Phone Number: (845) 445-2174 
 
§ 
Protocol Version and Date: 1.2 03/04/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue 
 
 
1.0 
Research Design 
 
 
1.1 
Purpose/Specific Aims 
 
 
1.2 
Research Significance 
 
 
1.3 
Research Design and Methods 
 
 
1.4 
Preliminary Data 
 
 
1.5 
Sample Size Justification 
 
 
1.6 
Study Variables 
 
 
1.7 
Drugs/Devices/Biologics 
 
 
1.8 
Specimen Collection 
 
 
1.9 
Data Collection 
 
 
1.10 Timetable/Schedule of Events 
 
 
2.0 
Project Management 
 
 
2.1 
Research Staff and Qualifications 
 
 
2.2 
Research Staff Training 
 
 
2.3 
Other Resources 
 
 
2.4 
Research Sites 
 
 
3.0 
Multi-Center Research 
 
 
4.0 
Subject Considerations 
 
 
4.1 
Subject Selection and Enrollment Considerations 
 
 
4.2 
Obtaining Identifiable Information About Non-Subjects 
 
 
4.3 
Number of Subjects 
 
 
4.4 
Consent Procedures 
 
 
4.5 
Special Consent Populations 
 
 
4.6 
Economic Burden and/or Compensation For Subjects 
 
 
4.7 
Risks of Harm/Potential for Benefits to Subjects 
 
 
5.0 
Special Considerations 
 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
 
5.3 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
5.4 
General Data Protection Regulation (GDPR) 
 
 
5.5 
 NJ Access to Medical Research Act (Surrogate Consent)  
 
 
6.0 
Data Management Plan 
 
 
6.1 
Data Analysis 
 
 
6.2 
Data Security 
 
 
6.3 
Data Safety And Monitoring 
 
 
6.4 
Reporting Results 
 
 
6.5 
Secondary Use of Data 
 
 
7.0 
Research Repositories – Specimens and/or Data 
 
 
8.0 
Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Research Design 
 
1.1 Purpose/Specific Aims 
This study aims to conduct a Stage II randomized-controlled trial of a novel behavioral intervention, 
titled Behavioral Exposure for Interoceptive Tolerance (BE-FIT), to evaluate (1) its efficacy in improving 
exercise adherence in cardiac rehabilitation (CR) and (2) its mechanisms of change.  
 
A. Objectives 
Objective 1. Compare physical activity outcomes (e.g., lifestyle physical activity levels, CR 
adherence) between participants randomized to receive BE-FIT or a health education control 
(HEC).  
Objective 2. Compare exercise anxiety levels between BE-FIT vs. HEC.  
Objective 3. Examine the mechanisms by which BE-FIT affects physical activity outcomes. 
 
B. Hypotheses / Research Question(s) 
Objective 1. We hypothesize that BE-FIT, compared to HEC, will result in higher levels of 
objectively measured, moderate-to-vigorous intensity physical activity at end-of-treatment and 
follow-up sessions. We also predict that BE-FIT vs. HEC control will produce a higher lifestyle 
physical activity (steps/day) on CR and non-CR days and higher rates of CR adherence (% of 
prescribed CR sessions attended).   
Objective 2. We hypothesize that, compared to a health education control, BE-FIT will generate 
greater reductions in exercise anxiety at end-of-treatment and Week 12. Specifically, we expect 
BE-FIT vs. HEC to produce (a) greater decreases in anxious cognitions (e.g., catastrophizing, 
uncertainty, intolerance); (b) greater decreases in safety behaviors; and (c) greater increases in 
cardiac vagal control, at end-of-treatment and Week 12.  
Objective 3. We hypothesize that reductions in exercise anxiety and related components (e.g., 
reduced cognitive bias, safety behaviors, increased vagal control) at end-of-treatment and Week 
12 will mediate the effect of BE-FIT on physical activity outcomes at Weeks 18 and 24.  
 
1.2 Research Significance 
Regular exercise and lifestyle PA are critical for quality of life and longevity among a growing aging 
population and are particularly important for a healthy heart. 1–3 Aging particularly produces changes to 
the structure and function of the heart 4–6, which explains the increase in risk of cardiovascular disease 
(CVD) related to advancing age. 7–11 Out of approximately 80 million Americans with CVD, adults aged 
60 years or older account for nearly 50% of cases and older adults account for more than 80% of CVD 
deaths. 11,12 Exercise can promote adaptations to the cardiovascular and pulmonary system and 
reverse cardiac aging phenotypes, which can help diminish the progression of age-related changes to 
the heart. 13,14  Despite these benefits, increasing age is related to decreased PA and exercise 
engagement. 15,16 Cardiac rehabilitation (CR), a multi-component secondary intervention used to speed 
recovery from acute cardiac events, provides a valuable window-of-opportunity to promote exercise 
and lifestyle PA 17,18, especially in aging adults who would benefit from individually tailored exercise 
prescriptions and supervision to guarantee safe uptake and maintenance of PA. 17  
 
However, adherence to CR is typically low, and exercise adherence in CR is expected to further 
decrease due to the advanced age of CR patients. 19–23 Therefore, there is a need to determine and 
target the obstacles for adherence to (a) exercise in CR and (b) lifestyle PA. One mechanism that is 
relevant to exercise and CR is fear of physical activity, or “exercise anxiety,” a construct with cognitive, 
behavioral, and physiological underpinnings. 24 For CR patients, exercise may be particularly alarming 
because the exercise sensations may be viewed as intolerable or indistinguishable from sensations 
typically associated with CVD (e.g., shortness of breath, dizziness, pain). 25–29 Indeed, our preliminary 
work found that exercise anxiety is common among 40-50% of patients attending outpatient PR and is 
related to exercise non-adherence. 30,31 
 
We developed a mechanism-informed behavioral intervention to target exercise anxiety called 

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Behavioral Exposure for Interoceptive Tolerance (BE-FIT). The three primary components of BE-FIT 
include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use 
before/during/after exercise, and (3) use of a wrist-worn activity monitor for PA feedback and activity 
goal setting. Evidence from our Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and 
produced reductions in exercise anxiety and exercise outcomes (short-term moderate-to-vigorous 
intensity physical activity and steps/day). Our present aim is to conduct a Stage II randomized-
controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in CR patients 
and examine whether changes in this target yield successive changes in exercise adherence outcomes.   
 
1.3 Research Design and Methods 
 
A. Research Procedures 
This study will be a prospective Stage II randomized-controlled trial with patients enrolled in cardiac 
rehabilitation at Robert Wood Johnson (RWJ) University Hospital Cardiac Rehabilitation Program. 
One hundred and forty-six patients in cardiac rehabilitation who have elevated exercise anxiety, as 
indicated by endorsement of much to very much concern about at least 3 items on the Exercise 
Sensitivity Questionnaire (ESQ; Farris et al., 2020), and who meet other eligibility criteria will be 
randomly assigned to either receive BE-FIT, an intervention tailored specifically for CR patients 
with high levels of exercise anxiety, or a health education control (HEC).  
 
B. Data Points 
Patients attending CR orientation at RWJ Cardiac Rehabilitation Program will be screened for study 
eligibility. Aside from screening, five independent assessments will be performed at baseline, end-
of-treatment (EOT), and three follow-ups at Weeks 12, 18, and 24 (See Table 1 in Section 1.9 
below.). All assessments will be performed at RWJ Cardiac Rehabilitation Program.  
 
1. Screening: Patients who are scheduled for CR orientation and have provided verbal 
agreement for study screening procedures (see telephone script) will have their medical 
records reviewed by study staff to assess for any potential inclusion/exclusion criteria (Medical 
Data Extraction Form). During orientation, patients will complete a measure of exercise anxiety 
(Exercise Sensitivity Questionnaire; ESQ) and exercise levels via the 2-item Exercise Vital Sign 
(EVS). Next, all patients will meet with the medical team during orientation, during which the 
physician and assistant review physical exams and cardiac history, administer the MoCA, and 
determine clearance for CR and study participation. Those appearing to meet eligibility criteria 
will be briefed by the research team about the opportunity to participate in a brief lifestyle 
program as an adjunct to CR, consented, and enrolled if interested. 
 
2. Baseline Assessment: Fully consented and enrolled patients will complete the following 
baseline assessment questionnaires (20-25 minutes): 
Self-Report Assessments:  
• 
Cardiac Anxiety Questionnaire (CAQ)32  
• 
Fear of Activity in Coronary Artery Disease (Fact-CAD)33 
• 
Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q)  
• 
Safety Behaviors Assessment Form (SBAF)34 
• 
Threat Perceptions35 
• 
Valuing Questionnaire (VQ)36 
• 
Intolerance of Uncertainty Scale Short Form (IUS-12)37 
• 
Falls Efficacy Scale-International (Short FES-I)  
• 
Discomfort Intolerance Scale-Revised (DIS-R)38  
• 
Body Vigilance Scale (BVS)39 
• 
Multidimensional Assessment of Interoceptive Awareness (MAIA)  
• 
Anxiety Sensitivity Index-3 (ASI-3)40 
• 
General Anxiety Disorder 7-Item Scale (GAD-7)41 
• 
Patient Health Questionnaire-9 (PHQ-9)42 
 

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These assessments, and those administered at end-of-treatment (EOT) and Weeks 12, 18, 
and 24 will be completed by an independent evaluator who will be blinded to aspects of CR 
treatment and study randomization. Patients will be informed to not discuss the nature of their 
treatment with the evaluator to minimize chance of bias.  
 
Physiological Assessment: Fully consented patients will also complete the following 
physiological assessments: a 5-min average resting respiratory sinus arrythmia (RSA), 5-
minute attentional demand, and 5-minute Stroop task. Respiration rate, heart rate, and 
baroceptor reflex will also be assessed at baseline. Participants will also be asked to wear a 
Fitbit activity tracker on their wrist during waking hours for at least 7 consecutive days for 10+ 
hours/day to establish baseline physical activity prior to randomization. Patients will be given 
instructions on using the Fitbit and the study tasks requested of them.  
 
Randomization: After completion of at least 7-days of PA monitoring, patients will be 
randomized to either BE-FIT or HEC using randomization procedures with age (older or equal 
to 65 years old/younger than 65) and sex (male vs. female) as blocking variables. Age and sex 
were selected as stratification variables because they are associated with anxiety and fitness 
levels which could impact PA outcomes.  Intervention sessions will coincide with scheduled CR 
sessions, but the study content (BE-FIT or HEC) is supplemental to CR. Research staff will 
schedule BE-FIT/HEC sessions in the medical record system in consultation with the CR 
coordinator to ensure that study sessions and CR appointments coincide, and patients receive 
reminder calls about the longer appointment times on visit days.  
 
3. Baseline-Week 24: Physical activity adherence will be measured continuously through Week 
24 via the Fitbit activity trackers.  
 
End-of-Treatment (EOT) & Weeks 12, 18, 24: Participants will complete the following self-
report measures (20-25 minutes)ESQ 
CAQ 
Fact-CAD 
PRETIE-Q 
SBAF 
Threat 
VQ 
IUS-12 
FES-I 
DIS-R 
BVS 
MAIA 
ASI-3 
GAD-7 
PHQ-9 
 
4. End-of-Treatment (EOT) & Week 12: Participants will complete the following physiological 
assessments: 5-min average RSA, 5-min attentional demand, and 5-min Stroop task, and 5-
min recovery. Respiration rate, heart rate, and baroceptor reflex will also be measured.  
 
5. At Week 18, the number of CR sessions attended by the participant will be assessed.  
 
 
 

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C. Study Duration 
The overall duration of the study is 24 weeks, or approximately 6 months. Subjects will be involved 
in 6 individual sessions delivered twice weekly during the initial weeks of outpatient CR. Sessions 
occur for 45 minutes either immediately before or after regularly scheduled CR sessions.  
 
1.4 Preliminary Data 
Prior research has found that anxiety sensitivity and fear of exercise are elevated in patients attending 
cardiac rehabilitation 43, and that 43.5% of patients enrolled in CR had scores at or above the cutoff for 
moderate fear of bodily sensations and that fear of bodily sensations was not significantly associated 
with what week in treatment patients were in. This suggests a lack of improvement in fear of bodily 
sensations over the course of standard CR treatment. Additionally, 18.3% of variance in fears and 
exercise avoidance was significantly associated with fear of bodily sensations after adjusting for age, 
sex, week of CR, CVD risk status, and anxiety and depressive symptoms. 
 
In a follow-up study with this same sample, we found that a sizable percent of patients in CR reported 
specific catastrophic exercise cognitions, including: not being able to breathe during exercise (51.3%), 
having a cardiac event during exercise (41.9%), and that something terrible physically might happen 
suddenly during exercise (40.2%); in addition, exercise safety behaviors were common, including 
stopping/slowing during exercise when experiencing sensations (72.6%) and avoiding exercise when 
alone because of heart health (32.5%). 30 We also found that practitioners (n=16; exercise physiologists 
in CR) used significantly fewer cognitive-behavioral strategies compared to safety-behaviors (e.g., 
providing reassurance about HR) in response to a hypothetical exercise anxiety scenario. Thus, both 
patients and CR practitioners may perform safety behaviors that can unintentionally maintain anxiety. 
The majority of patients (73%) and practitioners (100%) said it would be beneficial to address exercise 
anxiety in CR, suggesting wide interest in targeted intervention.  
 
We developed and validated the first measure of exercise anxiety called the Exercise Sensitivity 
Questionnaire (ESQ) for use in CR. 44 The ESQ is an 18-item self-report measure that conceptualizes 
exercise anxiety as worry and fear about the physical sensations of exercise. The ESQ has two 
dimensions: (1) anxiety about cardiopulmonary sensations during exercise (i.e., blurry vision, chest 
pain/tightness, difficulty breathing) and (2) anxiety about pain/weakness sensations during exercise 
(i.e., joint/back/body pain, aches, soreness). Among older adults enrolled in outpatient CR (n = 50): 
ESQ-Total (Mean=29.4, SD=18.0, Median=31.0, Observed Range = 0-66), ESQ-Total and subscales 
demonstrated high internal consistency (alpha’s = .90 to .93), and good convergent validity (with cardiac 
anxiety, discomfort intolerance). We also evaluated predictive validity in two samples. In the first sample 
(n = 252 adults with CVD risk, 23.4% with a CR qualifying condition), we found that adults with high 
exercise anxiety had a 67% lower likelihood of any past 7-day moderate-to-vigorous intensity physical 
activity (MVPA) participation (OR=.33, CI95%=0.13-0.81, p=.016) compared to those with minimal/no 
exercise anxiety. In a second sample of older adults in outpatient CR, exercise anxiety was correlated 
with lower objectively measured MVPA during a 7-day period (r = -.35).  
 
We evaluated BE-FIT in an open trial of patients (n=12) who were attending outpatient CR at the Cardio 
Metabolic Institute (CMI). The pilot study of BE-FIT involved an orientation session, six 30-minute 
individual sessions with a study interventionist delivered 2x weekly during the initial weeks of CR, and 
an exit interview to assess intervention acceptability. Assessments were conducted at baseline, mid-
treatment (session 3), and end-of-treatment (1-week post-treatment). At baseline and end-of-treatment, 
a 7-day PA monitoring period was completed. PA was monitored via wrist-worn activity monitor with 
heart rate sensor, which was provided to patients at orientation. We enrolled 12 patients 
(Mage=72±8.37yrs, range = 53-84yrs, 75% ≥ 65yrs; 25% female). Findings indicated that BE-FIT was 
highly feasible (100% session attendance, 97.5% watch compliance [wear ≥ 10hr/day]), acceptable, 
and safe (no adverse events reported). BE-FIT produced large, significant reductions in exercise 
anxiety and produced significant medium-sized increases in exercise (MVPA mins/day, steps/day), 
which was evidenced on CR and non-CR days.  
 
1.5 Sample Size Justification 
Power analyses focuses on estimating a sample size large enough to detect “true” effects, avoiding 

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Type II errors. Sample size estimates were obtained for intervention contrasts, and mediation effects 
via sample size and power equations using the G*Power software program. Based on pilot data (see 
1.4; Preliminary Data), we anticipate intervention effects of BE-FIT vs HEC to be in the medium to large 
range (d = 0.50-0.60).  Based on the proposed sample size of 146, given 5 assessment points, we 
anticipate the ability to detect effects of intervention contrasts in the medium to large range (Aim 1 and 
2) and mediation in the small to medium range (Aim 3). Considering maximum anticipated attrition rates 
of 15% (N = 124) we will have .80, .85, .90, and .95 power to detect effects sizes of delta = .30, .45, 
.50, and .60, respectively.  
 
1.6 Study Variables 
 
A. Independent Variables, Interventions, or Predictor Variables  
The independent variable will be the type of intervention received: BE-FIT vs. a health education 
control (HEC).  
 
BE-FIT: BE-FIT will consist of a 6-session one-on one program with a clinician that are 
approximately 45 minutes delivered, over the course of 3 weeks (twice/week). Sessions will 
coincide with scheduled cardiac rehabilitation sessions at RWJ Cardiac Rehabilitation Program. 
The elements of BE-FIT are (1) psychoeducation about avoidance/anxiety and values clarification 
and committed action for exercise and lifestyle PA; (2) graded, repeated exposure to bodily 
sensations and exercise to build tolerance of discomfort; (3) fading safety behaviors and elimination 
of exercise avoidance behaviors to promote tolerance of uncertainty and reduce catastrophizing; 
and (4) use of Fitbit activity tracker to facilitate physical activity monitoring and provide physical 
activity feedback and goal-setting.  
 
Session content is as follows*:  
• 
Session 1: Psychoeducation & Setting PA Goals 
 
In Session One, patients will be provided with a rationale for the BE-FIT via targeted 
psychoeducation about the relationship between bodily sensations, anxiety, and related 
exercise avoidance, and it will be explained that they can improve both their physical and 
mental health by actively participating in this program. The interventionist will review the 
patient’s anxiety about exercise, the specific feared sensations endorsed on the ESQ and 
their relationship to the patient’s cardiac events/procedures (e.g., surgery).  
 
Interventionists review the cognitive-behavioral model of anxiety, discuss normal 
(healthy) vs. feared exercise sensations, and the role of avoidance in maintaining anxiety 
and suffering. The interventionist will also review the role of exercise and lifestyle PA for 
healthy aging, and discuss how daily accumulation of short bouts (≥10 minutes) of both 
planned and unplanned activities as part of day life can aid in manageable and 
sustainable changes to lifestyle PA. Interventionists will help patients to identify values for 
exercise and PA change to aid in motivational enhancement for lifestyle change 
throughout the intervention. 
 
• 
Session 2: Rationale for Exposure/Fading Safety Behaviors & Developing Exposure 
Hierarchy 
 
Within the manualized intervention, therapists will follow a procedure to identify and 
target each participant’s feared exercise sensations. It is anticipated that patients will 
present with a variety of qualifying and co-morbid medical conditions, as well as a varied 
array of feared sensations which contribute to avoidance of PA. Any exercise sensations 
whether cardiopulmonary in nature or related to other sensitivities (e.g., pain, weakness, 
instability) are relevant to older adults with a variety of cardiovascular and other health 
issues, thus are targeted in BE-FIT. Patients will be provided the rationale and participate 
in guided practice of exposure – regular and systematic practice of avoided activities and 
activities that intentionally elicit feared bodily sensations. The goal of exposure is to 

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facilitate interoceptive tolerance and learning that sensations can be experienced without 
avoidance.45 Exposures will be planned by the interventionist in collaboration with the 
patient, exercise physiologist and cardiac technician, and tailored to each patients’ needs 
based on the nature of their anxiety and avoidance behaviors. Exposures will increase in 
difficulty during treatment to maximize tolerability and acceptance of bodily sensations. 
Patients will be reminded that sensations are normal reactions and that while they are 
uncomfortable, experiencing them during exposure will help them build tolerance and 
help to facilitate exercise and PA in the long term. Exposures will be practiced in session 
with the guidance of the interventionists: for example -- short bouts (1-2 min. intervals) of 
aerobic or resistance training to elicit certain body sensations, or other activities that elicit 
sensations like breathing through a straw (shortness of breath) or standing on one foot 
(wobbly balance).46,47 In addition, patients will be assigned exposure practice to be 
completed at home during lifestyle PA in order to facilitate generalizability of learning.  
 
• 
Sessions 3, 4, 5: Exposure Practice & Fading Safety Behaviors 
 
The interventionist will help patients to recognize and increase awareness of anxiety-
motivated behaviors and aid in identifying any patterns or persistent themes of 
avoidance. Interventionist will discuss how anxiety’s effect on avoidance can be overt 
(choosing not to engage in exercise when unsupervised, skipping CR because of anxiety) 
and subtle (i.e., less obvious ways). For example: ending bouts of walking earlier than 
planned, walking at a slower pace (lower intensity), or relying on safety (“just in case”) 
behaviors (e.g., calling someone to seek reassurance about bodily sensations). Because 
excessive HR checking is a common safety behavior in CR, thus will be proactively 
targeted as a ‘teachable moment’.  
 
Patients will be taught how checking HR during exercise (e.g., via Fitbit) provides safety 
reassurance in the moment but can reinforce false beliefs that exercise is only safe 
because of HR feedback (e.g., “It’s only ok for me to be active because I’ve checked to 
be sure my heart rate is in the safe zone), thus while safety checking behaviors 
temporarily alleviating distress, they ultimately narrow the range of tolerated conditions 
for exercise. Fading and eventual elimination of safety behaviors will be encouraged 
during exercise to aid in reduction of anxiety, including shifts in cognitions about exercise 
(e.g., increase tolerance for uncertainty; reduce catastrophizing).  
 
• 
Session 6: Goal Setting and Planning for Maintenance of Physical Activity 
 
BE-FIT will be administered by doctoral-level clinicians who are trained exclusively to deliver BE-
FIT. The interventionist will work with the study exercise physiologist to coordinate tailoring of BE-
FIT content to the patient.  
 
*Note: Physical activity monitoring and feedback occur at each session.  
 
Health Education Control (HEC): HEC is a time-matched control intervention that will be 
administered on the same “delivery schedule” as BE-FIT. The intervention content includes: (1) 
educational information about health topics relevant to healthy aging, and (2) Use of the Fitbit 
activity watch for PA monitoring. The 6 topics introduced in the HEC include: nutrition, sleep, brain 
health, emotional health, living with chronic conditions, how to be a smart patient. The health 
information will be conveyed through lectures and handouts. The goal of sessions will be to provide 
education, particularly as it relates to healthy aging. Patients will be given the same Fitbit as in the 
BE-FIT but will not be given PA goals.  
 
The HEC will be delivered by two doctoral-level clinicians who will be trained to exclusively deliver 
HEC and will differ from the interventionists administering BE-FIT to avoid contamination. 
Interventionists will routinely address questions related to the Fitbit such as syncing issues, 
charging the battery, and any other technical problems that may arise. 

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B. Dependent Variables or Outcome Measures  
The primary outcome is objectively measured exercise (moderate-to-vigorous intensity physical 
activity mins/day) on both CR and non-CR days. The secondary outcomes are (1) % of prescribed 
CR sessions attended and (2) objectively measured lifestyle PA (steps/day). Target mechanisms 
are exercise anxiety and its components (cognitions, safety behaviors, and cardiac vagal control).  
 
1.7 Drugs/Devices/Biologics  
N/A 
 
1.8 Specimen Collection 
N/A 
 
1.9 Data Collection 
 
A. Primary Data Collection 
§ 
Location: All data collection will occur at RWJ Cardiac Rehabilitation Program locations in 
New Brunswick and East Brunswick.  
§ 
Process of Data Collection: Data will be collected via participant self-reports and Fitbit 
Charge 5 activity trackers that will be worn by enrolled participants. An independent evaluator 
will collect self-report assessments. Graduate-level research assistants will administer the 
physiological assessments and treatment sessions (BE-FIT or HEC) to participants. Dr. Farris 
will be responsible for overseeing the data collection process.  
§ 
Timing and Frequency: All participant study visits will occur during their regularly scheduled 
CR appointments at RWJ Cardiac Rehabilitation Program. The screening visit will occur 
during the patient’s orientation. The treatment sessions will occur for 45 minutes biweekly for a 
period of 3 weeks either immediately before or after their regularly scheduled CR sessions. 
EOT and 12-week Follow-Ups will coincide with patients’ CR appointments. Week 18 and 24 
Follow-Up appointments will be scheduled at participants’ convenience, coinciding with 
medical appointments when possible. 
§ 
Procedures for Audio/Visual Recording: Drs. Farris and Leyro will monitor adherence 
through weekly supervision and audiotape-review of sessions (separate supervision groups 
for BE-FIT and HEC interventionist). Additional details regarding audio recordings will be 
included in the consent document given to patients. All audiotapes will be erased upon 
completion of data analysis. Audio-recorded data will be stored in a locked filing cabinet and 
the tapes will be destroyed after the data is analyzed.  
 
 

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§ 
Study Instruments:  
 
 
 
Demographics. General demographic information including age, sex, race/ethnicity, income 
level and level of education will be collected from medical records and/or at the baseline 
assessment. 
 
Health and Exercise History. Psychological and health history will be evaluated at baseline. 
Medical records will be referenced at baseline to determine eligibility based on cardiac 
diagnosis, medical conditions and medications, and score on Exercise Sensitivity Questionnaire 
(ESQ; see preliminary data). Cognitive ability will be assessed using the Montreal Cognitive 
Assessment (MoCA). 48 The 2-item Exercise Vital Sign will be utilized to measure patients’ self-
reported exercise levels. 49 
 
Exercise Anxiety. The Exercise Sensitivity Questionnaire (ESQ) will be used to measure 
exercise anxiety. 31 Please see the preliminary data section for more information related to the 
measure’s reliability and validity.  
 
Psychological Functioning. Validated measures commonly used in medical settings to screen 
for common psychiatric conditions (PHQ-942, GAD-741),a measure of values-consistent living 
validated for use in CVD populations (Valuing Questionnaire36,50; VQ), and a general index of 
anxiety sensitivity (Anxiety Sensitivity Index; ASI-3)will be administered. 
 
Anxious Cognitions. Validated report assessment of anxious cognitions will be used to tap 
catastrophizing (Cardiac Anxiety Questionnaire; CAQ40 and Threat Perceptions), intolerance of 
uncertainty (Intolerance of Uncertainty Scale-Short; IUS-12)51, discomfort intolerance 
(Discomfort Intolerance Scale; DIS)52, interoceptive awareness and appraisal (Body Vigilance 
Scale; BVS and Multidimensional Assessment of Interoceptive Awareness; MAIA), and fear of 
falling (Falls Efficacy Scale-International (Short FES-I).  
 

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Avoidance/Safety Behaviors. Avoidance behaviors will be assessed via the Safety Behaviors 
Assessment Form (SBAF)14 and  Fear of Activity in Coronary Artery Disease (Fact-CAD), and  
The Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q). 
 
Physical Activity. A Fitbit activity tracker will be used to assess how much physical activity 
participants partake in per day and objective exertion of exercise. A number of options exist 
for goal-setting and we will customize each participant’s account to display the following: daily 
steps, very active minutes, and activity during each hour of the day. While the vast majority of 
lifestyle PA will consist of walking, Fitbit trackers are waterproof and can be worn while 
swimming. Also, we will provide exchangeable clips to allow for trackers to be attached to a 
sneaker when cycling. In doing so, we likely capture all types of lifestyle activities.  
 
During Session One, the interventionist will review baseline PA from the baseline assessment, 
including daily steps and MVPA. The interventionist will use these data to tailor two possible 
PA prescriptions (goals) – (1) Increasing steps/day: If baseline steps/day reflect  
sedentary/low activity (accumulate avg<4,000 steps/day),54 patients will be given the goal of 
achieving 4,500 steps/day and increasing each session by 500 steps/day (about 1/4 mile 
increase), as recommended by the recent update to PA guidelines.55 At this rate, patients will 
reach ~7,500 steps/day by EOT, which is an empirically-derived minimum for daily PA in older 
adults for longevity;56 and/or (2) Increasing PA intensity: If baseline active min/day reflect low 
MVPA (accumulated avg < 30 active mins/day), patients will be given the goal of working 
gradually towards achieving and maintaining 30 very active minutes/day. This gradual 
approach is consistent with implementation of exposure therapy46 and will ensure that patients 
are not engaging in anxiety-driven avoidance of higher intensity-PA. 
 
Physiological Parameters. To assess cardiac vagal control as a physiological parameter of 
exercise anxiety and a putative BE-FIT target, respiratory sinus arrhythmia (RSA), an index of 
cardiac vagal control will be indexed at baseline, end-of-treatment, and 12-Week follow-up. At 
each time point, we will specifically assess cardiac vagal control during a 5-minute resting period 
(i.e., tonic) and cardiac vagal reactivity during a 5-minute attentional demand (i.e., phasic 
changes in RSA), which has previously been used to assess acute changes in cardiac vagal 
control as an index of psychological flexibility and vulnerability.57 We will also assess heart 
rate deceleration (event-related potential) in response to a 5-min Stroop task. Continuous 
measures of electrocardiograph (ECG), impedance cardiograph (IC), and blood pressure (BP) 
will be acquired at 1000 Hz using a Biopac MP150 and an integrated CNAP blood pressure 
monitor. Signals will be scored and offline in 1-minute bins in accordance with 
recommendations of the Society for Psychophysiological Research58–60 using MindWare’s 
integrated system (BioNex 8SLT Biolab Acquisition Application, MindWare Technologies, 
Gahanna OH).  
 
RSA will be specified as the integral power within typical adult respiration frequency (.12 to .4 
Hz), and respiration rate will be derived from IC. Reactivity will be computed by subtracting 
baseline scores from the attentional demand scores; because RSA decreases during 
attentional demand, lower numbers for vagal reactivity represent greater reactivity. Cardiac 
output will be calculated with the Kubicek formula to provide an estimate of the amount of 
blood processed by the heart in 1 min. The pre-ejection period will be measured as the time in 
ms from the onset of ventricular depolarization to the aortic valve opening. Continuous 
assessment of BP will allow scoring of the baroreceptor reflex, defined as changes in the 
interbeat interval per unit change in BP (ms/mmHG), a supplemental index of vagal control. 
Use of beta blockers will be used as a covariate when interpreting parameters given its 
physiological effects. 
 
§ 
Subject Identifiers: All study data will be coded with a de-identified study ID number. 

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1.10 Timetable/Schedule of Events 
 
CR Orientation: Prior to the eligibility screen, patients will already be scheduled for their CR orientation at 
RWJ Cardiac Rehabilitation Program in New Brunswick, NJ. Medical records for these patients will be 
screened by study staff to assess potential eligibility.  
 
Eligibility Screen/Medical Clearance: In addition to reviewing patient medical records, patients will 
complete an assessment of exercise anxiety (ESQ) and exercise levels via the 2-item Exercise Vital Sign 
(EVS) during CR orientation. Next, all patients meet with the medical team during orientation, during which 
the physician and assistant will review physical exams and cardiac history, administer the MoCA, and 
determine clearance for CR and study participation. Potentially eligible subjects will be approached by study 
staff at their CR orientation visit to see if they’re interested in the study.  
 
Recruit & Consent: Those appearing to meet eligibility criteria will then be fully briefed by the research 
team about the opportunity to participate in a brief lifestyle program as an adjunct to CR. After receiving 
this thorough introduction, they will complete informed consent for study enrollment, if interested. 
 
Baseline: Baseline appointments will be scheduled with interested and potentially eligible patient on the 
same day as orientation or on a subsequent day, based on patient preference. Enrolled patients will 
complete the baseline assessments, be provided with the Fitbit, and be shown how to wear and charge it. 
Patients will be required to wear the Fitbit for at least 7 consecutive days for 10+hrs/day to establish 
baseline PA activity prior to randomization. The following self-reports will be administered at baseline:  
 
• 
Fact-CAD 
• 
PRETIE-Q 
• 
PHQ-9 
• 
GAD-7 
• 
VQ 
• 
CAQ 
• 
IUS-12 
• 
FES-I 
• 
DIS-R 
• 
BVS 
• 
SBAF 
• 
Threat Perceptions 
• 
MAIA 
• 
ASI-3 
 
 
 

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The following physiological assessments will be completed:  
• 
Vagal tone 
• 
Vagal flexibility  
• 
Respiration rate, heart rate, and baroceptor reflex 
 
Randomization to BE-FIT/HEC: After completion of at least 7-days of PA monitoring, patients will be 
randomized to either BE-FIT or HEC. Intervention sessions will coincide with scheduled CR sessions, but 
study content will be supplemental to the CR. The sessions are scheduled in this way to minimize risk of 
treatment contamination. Research staff will schedule BE-FIT/HEC sessions in the medical record system 
in consultation with the CR coordinator to ensure that study sessions and CR appointments coincide, and 
patients receive reminders about longer CR visits on study days. BE-FIT or HEC will be delivered biweekly 
for 3 weeks before or after a patient’s scheduled CR sessions (please see Independent Variables, 
Interventions, or Predictor Variables for more details on these treatment types).  
 
End-of-Treatment (EOT) and Follow-up Assessments (Week 12, 18, and 24): At EOT and weeks 12, 
18, and 24, patients will complete assessments that involve multimethod approaches including a medical 
record review, interview with independent evaluator, self-report questionnaires, and objective physical 
activity monitoring.  
• 
The following self-report assessments will be administered at EOT and Weeks 12, 18 & 24: ESQ  
• 
Fact-CAD 
• 
PRETIE-Q 
• 
PHQ-9 
• 
GAD-7 
• 
VQ 
• 
CAQ 
• 
IUS-12 
• 
FES-I 
• 
DIS-R 
• 
BVS 
• 
SBAF 
• 
Threat Perceptions 
• 
MAIA 
ASI-3Physiological assessments via ECG/Impedance Cardiography using Biopac MP150 will be 
administered at EOT and Week 12:  
 
• 
Vagal tone 
• 
Vagal flexibility  
• 
Respiration rate, heart rate, and baroceptor reflex 
 
Physical activity adherence will be assessed throughout the study (Baseline to Week 24) via the Fitbit 
activity trackers.  
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
Samantha G. Farris, Ph.D., (Principal Investigator, Director of REHAB Lab). Dr. Farris is an 
Assistant Professor in the Department of Psychology at Rutgers University and is a licensed clinical 
psychologist. Dr. Farris has published over 80 peer-reviewed publications, with a primary focus on 
fear of bodily sensations and somatization and its role in the maintenance of problem health 
behaviors, including physical inactivity. Dr. Farris’ training and research has been supported by NIH 
for the past 6 years (R25-CA057730; T32-HL076134; F31 DA035564; PI Farris) and has served as a 
project director on 8 NIH-funded intervention trials. Dr. Farris completed a two-year fellowship in 
Cardiovascular Behavioral Medicine at the Brown Medical School (Providence, Rhode Island), during 
which she conducted research and clinical work in Outpatient Cardiac Rehabilitation. Dr. Farris has 
expertise in cognitive-behavioral and exposure-based interventions for anxiety disorders, including 

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fear of bodily sensations, and has trained and supervised research therapists on the delivery of 
interoceptive exposure to target somatization. On the present study, Dr. Farris will be the overall 
scientific director of the proposed work and will be responsible for maintaining the scientific and 
procedural integrity of the project. She will work closely with the co-investigators to provide training 
and ongoing weekly supervision to research staff involved in assessment procedures and to 
therapists in the provision of the treatment. Additionally, Dr. Farris will oversee the data management 
and analysis and will assume primary responsibility for the preparation of scientific reports and the 
dissemination of the results of the study. 
Teresa Leyro, Ph.D. (Co-Principal Investigator, Director of ABUSA Lab). Dr. Leyro is a licensed 
clinical psychologist experienced in research on anxiety, including adults with panic disorder 
(F31DA024919) and adults with mixed anxiety/depression (R34DA043751; R03DA041556). She also 
has experience in the measurement of physiological parameters (R34DA043751; R03DA041556). 
She completed a Ph.D. in Clinical Psychology at the University of Vermont where she served as a 
member of the Vermont Tobacco Evaluation and Review Board. Dr. Leyro completed post-doctoral 
training in substance abuse treatment and services research at the University of California, San 
Francisco. She will be aiding in referrals and recruitment of participants through a shared universal 
phone screen. Dr. Leyro will work closely with Dr. Farris to provide training and ongoing weekly 
supervision to research staff involved in assessment procedures and to therapists in the provision of 
the treatment. She will also oversee the data management and analysis with Dr. Farris.  
Brandon Alderman, Ph.D., Co-Investigator. Dr. Alderman is an Associate Professor and Vice Chair 
in the Department of Kinesiology and Health at Rutgers University, and is the Director of the Rutgers 
Exercise Psychophysiology Lab. Dr. Alderman has established a patient-oriented research program 
to study how exercise and other behavioral interventions can be used to enhance physiological, 
neurocognitive and psychological resilience. His work utilizes the use of advanced 
psychophysiological techniques including impedance cardiography and electroencephalography to 
better inform intervention development. Dr. Alderman will provide input on all aspects of the project. 
Additionally, Dr. Alderman will assist with biofeedback and exercise monitoring to maximize efficacy 
of the intervention protocol. During the later stages of the project, Dr. Alderman will assist with data 
management protocols for exercise data and will participate in the preparation of scientific reports and 
dissemination of study results. 
Angelo DiBello, Ph.D., Co-Investigator. Dr. DiBello is an Associate Professor in the Center for 
Alcohol & Substance Use Studies at Rutgers University. Dr. DiBello has expertise in advanced data 
analyses and experience in conducting longitudinal analyses specific to behavior change 
interventions. He has specific training and proficiency in areas consistent with this research 
application and is well-prepared to serve as a Co-Investigator and lead analyst for the study being 
proposed in this application. Over the past 7 years he has contributed to the execution of 5 RCTs, 
and he has relevant experience running large scale NIH-funded projects. Dr. DiBello will serve as the 
primary data analyst and conduct primary and secondary analyses with a specific focus on modeling 
non-normal exercise related outcomes.   
Michael Steinberg, MD, MPH (Collaborator, RWJ Cardiac Rehabilitation Program). Dr. Steinberg 
Professor and Chief in the Division of General Internal Medicine as well as Vice-Chair of Research for 
the Department of Medicine at Rutgers Robert Wood Johnson (RWJ) Medical School. He is involved 
in connecting researchers with primary care clinics within the RWJ University Hospital network where 
they can evaluate their treatments. He will facilitate recruitment efforts and providing additional 
support, if needed, to recruit subjects at other clinics in order to meet study enrollment goals.    
Anagha Babu, B.S. (Lab Manager). Ms. Babu is the laboratory manager of the Rutgers Emotion 
Health and Behavior Laboratory (REHAB Lab), which Dr. Farris serves as the director of. Ms. Babu 
completed her B.A. in Applied Mathematics & Statistics at Johns Hopkins University. Ms. Babu will 
assist in the preparation of all assessment materials, subject recruitment, screening, and scheduling 
participants, and will assist with conducting baseline and follow-up visits. She will also be responsible 
for the coding, entry, and verification of study data and oversee all research assistants. 
Sonali Singal, (Lab Manager): Ms. Singal is the laboratory coordinator of the Affective and 
Biological Underpinnings of Substance Abuse Laboratory (ABUSA Lab) under the direction of Dr. 
Teresa Leyro (Co-I). Ms. Singal has completed her B.S. in Psychology from Northeastern University 
and has multiple years of experience conducting research in psychology, as well as working with 
clinical populations. Ms. Singal oversees study protocol for Dr. Leyro’s various projects, which include 

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data management, subject assessments, conducting intervention, baseline, and follow-up protocols, 
and overseeing undergraduate research assistants. 
Sayaka Carpenter, (Study Coordinator): Ms. Carpenter is a study coordinator in the Rutgers 
Emotion Health and Behavior Laboratory (REHAB Lab), directed by Dr. Samantha Farris. Ms. 
Carpenter completed her B.S. in Exercise Science at Rutgers University during which time she 
conducted research in Dr. Brandon Alderman’s (Co-I) Exercise Psychophysiology Laboratory. Ms. 
Carpenter will be assisting in the preparation of BE-FIT study materials and overseeing 
undergraduate research assistants. She will also serve as the primary Independent Assessor during 
study start-up, collecting physiological and self-report data at baseline and follow-up visits, 
 
 
 
• 
Undergraduate and Post-bacc Research AssistantsAastha Parikh 
• 
Aisha Ghauri 
• 
Asher Hong 
• 
Dana Steinberg 
• 
Dipabali Jana 
• 
Eric Quartey 
• 
Sarah Farhan 
• 
Huong Le 
• 
Jason Marum 
• 
Kathleen Kildosher 
• 
Kunj Patel 
• 
Melissa Kao 
• 
Muhammad Razi Hussain 
• 
Samantha Stucchi 
• 
Sarah Farhan 
• 
Sathya Gopinath 
Yuthikaa RajUndergraduate and Post-bacc research assistants may assist in entering, cleaning, and 
scoring participant data at the REHAB Lab. 
 
2.2 Research Staff Training 
Study staff will complete CITI training for working with human subjects and will be trained using Fitabase 
software and Fitbit physical activity watches. BE-FIT training will be conducted by Drs. Farris and Leyro, 
Graduate Student Interventionists and Independent Assessors. 
• 
Mindy Kibbey, M.S 
• 
Erick Fedorenko, M.S 
• 
Jacqueline Smith, M.S. 
• 
Hannah Brinkman, M.S 
• 
Danielle Hoyt, M.A. 
• 
Andrew Ude,, M.S. 
• 
Lilly Derby, B.S. 
• 
Shelby Bandel, M.S.  
• 
Taylor Rodriguez, M.
Ms. Kibbey, Mr. Fedorenko, Ms. Smith, Ms. Brinkman,  Ms. Hoyt, Ms. Derby, Ms. Bandel, and Ms. 
Rodriguez are all current graduate students in the Clinical Psychology Ph.D. program at Rutgers 
University. They will serve as either (1) interventionists at RWJ Cardiac Rehabilitation Program, 
meeting with patients in order to deliver their treatment sessions in either the BE-FIT or HEC 
condition, or (2) independent assessors administering study measurement tools and 
psychophysiological monitoring protocols. Mr. Ude is a current graduate student in the Department of 
Kinesiology under the supervision of Dr. Brandon Alderman (Co-I ) and has experience in 
psychophysiological assessment and exercise science. He will serve as an independent assessor. 
Under the oversight of PI Dr. Farris, all graduate student evaluators will be trained in intervention 
protocol in order to ensure optimal practice of patient interactions and informed delivery of patient 
care. All graduate student research assistants have prior research and clinical experience and are 
familiar with standard research procedure including confidentiality and ethical practice. 

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who will provide overviews of the conceptual and theoretical bases of the approaches, as well as 
providing practical recommendations for protocol delivery and opportunities to practice the 
implementation of the protocols. We will employ a previously developed treatment fidelity assessment 
tool 61 based on NIH’s Behavior Change Consortium (BCC) framework that includes the 5 domains: 
treatment design, training providers, delivery of treatment, receipt of treatment, and enactment of 
treatment skills. This framework has been employed in the context of PA interventions 62. We also 
developed an adherence manual for BE-FIT. The fidelity rater will indicate whether a specific treatment 
component was discussed in the session. If interventionist-drift is detected, interventionists will be given 
feedback and the problem will be corrected through supervision.  
 
2.3 Other Resources  
The primary research setting will be RWJ University Hospital Cardiac Rehabilitation Program in New 
Brunswick and East Brunswick, NJ. See Letter of Support from Dr. Steinberg. The RWJ Cardiac 
Rehabilitation Program is an American Association of Cardiovascular and Pulmonary Rehabilitation 
nationally certified program that provides supervised exercise regimens and health education for CR 
patients. RWJ Cardiac Rehabilitation Program has electronic medical database and paper charts with 
patient records that clinicians and therapists will use to inform the study in terms of patient eligibility 
and scheduling. The RWJ Fitness and Wellness Centers contain state-of-the-art exercise facilities 
including exercise bike ergometers, treadmills, step machines, exercise arm ergometers, and elliptical 
machines which will be utilized by participants in the study. There are also private rooms used to 
conduct individual assessments and interventions. These rooms include computers that can be used 
to assess medical records. Participants will be patients at RWJ Cardiac Rehabilitation Program, and 
all assessments will take place the same day as their sessions there.  
 
The REHAB Lab will be utilized for data analysis. The lab includes a 7-room suite (approximately 
1,200 square feet) and a research exercise facility (600 square feet), all dedicated for Dr. Farris’ 
research. Each of the offices used by the REHAB Lab contains at least one or more networked 
computers (Dell PC computer). These machines are used for data entry, data analysis, and 
centralized communications among Dr. Farris and research staff. All workstations are equipped with 
computers that operate on Windows XP platforms and are linked to a local secure network with email, 
a dedicated server and remote access to Rutgers University libraries and catalogs. The REHAB Lab 
is equipped with a high-capacity Hewlett Packard LaserJet printer, an additional HP color printer, a 
high-capacity copy machine, a fax machine, and a color scanner. All computers are equipped with a 
variety of licensed research related software packages including Microsoft Office, SPSS (v. 25), and 
Stata (v. 10). The Psychology Department provides full IT and application support by a full-time 
dedicated employee. 
 
2.4 Research Sites 
The research will be conducted in partnership Robert Wood Johnson (RWJ) University Hospital 
Cardiac Rehabilitation Program. Research activities will take place at the program’s New Brunswick 
location at 100 Kirkpatrick St, #201, New Brunswick, NJ 08901 and at the East Brunswick location at 
593 Cranbury Road, East Brunswick, NJ 08816.  
 
3.0 Multi-Center Research 
 
All research will be conducted in collaboration with RWJ University Hospital Cardiac Rehabilitation 
Program. 
 
Data will be accessed by IRB-approved personnel for analysis at the Rutgers Emotion, Health and 
Behavior (REHAB) Laboratory overseen by Dr. Farris in the Department of Psychology at Rutgers 
University, 1 Spring St., New Brunswick, NJ, 08901. 
 
4.0 Subject Considerations 
 
4.1 Subject Selection and Enrollment Considerations  

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A.   Method to Identify Potential Subjects and Recruitment Details 
Subjects will be recruited at RWJ Cardiac Rehabilitation Program. Potential subjects will be 
identified via the RWJ Cardiac Rehabilitation Program medical records system which will include 
both electronic records and paper charts. Patients scheduled for CR orientation who verbally agree 
to screening procedures will have their medical record pre-reviewed by study staff prior to their 
orientation visit to assess potential inclusion and exclusion criteria.  
 
Patients who are identified as eligible by study staff and have been cleared by staff at RWJ Cardiac 
Rehabilitation program will be approached by a member of the study team who will use a 
recruitment script to introduce themselves to the patient and provide initial information about the 
study. Patients will also receive a study brochure that will include more details about the study.  
 
B.   Subject Screening 
Individuals who are attending CR orientation at RWJ Cardiac Rehabilitation Program in New 
Brunswick and East Brunswick will be screened for study eligibility.  
§ 
Inclusion Criteria: 
1. ≥ 40 years of age 
2. Elevated exercise anxiety (score of ≥ 30 on ESQ-18) 
3. Low active (< 90 min self-reported moderate-to-vigorous intensity physical 
activity/day in past three months) 
4. Medically approved cardiac rehabilitation  
5. English proficiency  
§ 
Exclusion Criteria:  
1. Evidence of cognitive impairment (< 23 on Montreal Cognitive Assessment; MoCA) 
2. Severe disabling chronic medical and/or psychiatric comorbidities determined on a 
case-by-case basis that prevents safe or adequate participation  
3. Expectation that patient will not live through study periods  
 
C. Privacy Protections 
Subject identifiers will be coded with a de-identified study ID number. There will be one physical 
copy of names with corresponding study ID numbers that will be kept under lock and key at the 
REHAB Lab suite in Spring Street. There will also be a password-protected digital copy of the 
participant database that can be accessed by 1-2 members of the research staff (study coordinator 
and Dr. Farris). Patient health records can only be accessed via the RWJ Cardiac Rehabilitation 
Program electronic records system or paper charts and will only be accessed by trained study staff 
at the site according to RWJ Cardiac Rehabilitation policy.  
 
4.2 Obtaining Identifiable Information About Non-Subjects 
We may potentially collect the name and phone number of caretakers or family members who help 
manage the scheduling and/or transportation for patients at RWJ Cardiac Rehabilitation Program. 
This information will be collected to advise the caretaker of the patient’s appointment schedule. We 
will first ask patients to provide contact information for their family member/caretaker and then obtain 
verbal consent from the caretaker to contact them and to have their contact information saved in a 
secure file. These non-subjects will also be briefed on the study protocol.  
 
4.3 Number of Subjects 
 
A. Total Number of Subjects 
We will recruit 146 subjects enrolled in CR with elevated exercise anxiety across both locations 
of RWJ Cardiac Rehabilitation Program. This is the total number of subjects needed to complete 
the research procedures.   
     B. Feasibility  
In our Phase I pilot study, we screened a total of 79 patients over the course of 9 months (~8.5 
/month). Of those screened, roughly 50% were eligible, of which ~50% enrolled (2.5/month). 
Notably though, this pilot was operating with a lean research staff which limited our capacity to 

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fully screen all patients scheduled for CR orientations, in addition to our inability to enroll eligible 
patients (n=7 not enrolled due to staffing limitations). Given the planned, slower pace of 
recruitment for our pilot study, our original recruitment rates do not fully reflect our capabilities. 
With increased effort and resources devoted to recruitment, we expect to enroll a greater 
proportion of eligible patients and eliminate instances where enrollment/recruitment is otherwise 
limited by staffing availability.  
 
Given the proposed staffing and resources from our grant, we will be positioned to allow all 
eligible and interested patients into the RCT. With our expanded capacity, we expect to be able to 
enroll all eligible and interested patients, which based on the pilot numbers would be ~60% of 
eligible patients (and 33% of screened patients). Given that RWJ Cardiac Rehabilitation Program 
treats ~150 pts/year in CR, we expect that approximately 75 patients/year would be eligible, of 
which ~45 patients would enroll per year (~3-4 pts/month). At this rate, we would be able to meet 
our planned recruitment of 146 over ~40 months.  
 
In the event that further assistance is needed to support recruitment for the proposed study, we 
will work with Co-I Dr. Steinberg to facilitate the necessary recruitment efforts within additional 
outpatient cardiac rehabilitation clinics at RWJ University Hospital.  
 
4.4 Consent Procedures 
 
A. Consent Process 
§ 
Location of Consent Process 
Informed consent will be obtained at RWJ Cardiac Rehabilitation Program, an outpatient 
cardiac rehabilitation program in New Brunswick, NJ.  
§ 
Individual Roles for Researchers Involved in Consent 
REHAB laboratory staff, including project coordinators, graduate students, and research 
assistants will all be appropriately trained to obtain verbal and written consent from potential 
participants.  
§ 
Consent Discussion Duration 
The consent discussion will take approximately 15-20 minutes. At this time, patients will have 
the study pitched to them, be told of the potential benefits and risks of participation and have 
the chance to ask questions about procedures/participation. If subject is still interest after the 
consent discussion, they will be asked to sign and date the consent form.  
§ 
Coercion or Undue Influence 
Interested and eligible patients will be told that their decision to participate is completely 
voluntary. Study staff will emphasize to patients that they will still complete their regular CR at 
RWJ Cardiac Rehabilitation Program if they choose not to participate, that there is no penalty 
to them if they choose not to participate, and they will not lose any benefits that are entitled to 
as a patient at RWJ Cardiac Rehabilitation Program.  
§ 
Subject Understanding 
Potential participants will be approached by a trained member of REHAB laboratory staff who 
will explain all aspects of the study, including potential risks and benefits and the expected 
duration and time commitment. If a patient verbally consents, they will be a given a written 
consent form detailing the nature of the study, as well as the opportunity to ask any 
questions. Subjects will be informed that they may discontinue their participation at any time. 
The consent form will also include authorization of use of protected health information (PHI) 
from patients’ medical records and the participant will also be made aware they are signing 
over access to that information.  
§ 
Protecting Privacy 
There will be a designated space at RWJ Cardiac Rehabilitation Program for communication 
between study staff and patients where they will be able to privately sign consent and ask 
any questions regarding participation. This designated space will also have the same 
safeguards in place as the spaces dedicated to regularly scheduled appointments at RWJ 
Cardiac Rehabilitation Program.  
 

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B. Waiver or Alteration of Consent Process  
We are not requesting Waiver of Documentation of Consent, Waiver or Alteration of Consent 
Process, Destruction of Identifiers, or Use of Deception/Concealment. 
 
C. Documentation of Consent 
§ 
Documenting Consent 
Trained REHAB laboratory staff will obtain verbal consent from potential participants prior to 
giving them a written consent form at RWJ Cardiac Rehabilitation clinics. Written informed 
consent will only be from patients medically cleared for the study by their attending 
cardiologist who are scheduled to start CR. Individuals will be asked to sign the consent 
document in front of a trained member of the REHAB laboratory.   
 
4.5 Special Consent Populations 
      N/A 
 
4.6 Economic Burden and/or Compensation for Subjects 
 
A. Expenses  
Patients will partake in the study at RWJ Cardiac Rehabilitation Clinics on the same day as their 
scheduled cardiac rehabilitation sessions. They are not expected to unduly undertake additional 
expenses as all equipment will be provided to them. 
 
B. Compensation/Incentives 
Patients will be compensated up to $705.00 for participation via cash:  
• 
$100 for the baseline assessment 
• 
$100 for end-of-therapy follow-up at week 6 
• 
$100 for 12-week follow-up  
• 
$50 for 18-week follow-up 
• 
$50 for 24-week follow-up 
• 
$100 bonus for completing all assessment visits  
• 
$10 per week for every week of 5 or more days of valid wear time (i.e., 10 hours/day;  
25 weeks = max $250) 
 
C. Compensation Documentation 
Compensation will be recorded and tracked via a password-protected subject payment 
database within Excel that can only be accessed by research staff. The Excel file can be 
accessed via the Dell PC computers within the REHAB laboratory suite in 1 Spring Street that 
are connected to a local secure network. Participants will also sign and date two receipts to 
confirm that they were compensated. Participants will keep one copy, and the other will be 
stored in the respective participant’s folder that will be housed in one of our filing cabinets in 1 
Spring Street under lock and key.  
. 
  
4.7 Risks of Harm/Potential for Benefits to Subjects 
 
A. Description of Risks of Harm to Subjects 
• 
Reasonably Foreseeable Risks of Harm 
 
Injury or medical complications during physical activity 
 
Risks. There are minimal risks associated with participation in moderate-intensity bouts 
of physical activity.  
Minimization. The most common injuries include muscle strains, joint sprains, and bone 
injuries. To minimize the risk of injury, participants will be instructed in appropriate warm-
up and cool-down exercises. During brisk walking, heart rate and blood pressure may 

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increase. Under extreme conditions, this can lead to a serious cardiac event. Only 
patients deemed medically appropriate by their cardiologist will be enrolled in the study. 
Home-based moderate-intensity physical activity is consistent with exercise goals in 
cardiac rehabilitation. Patients will be instructed to engage in moderate-intensity physical 
activity (64-76% age-predicted heart rate max) and will be given biofeedback during 
treatment to ensure that exercise is occurring at the appropriate intensity. Study staff will 
be able to monitor activity and heart rate levels in real-time. Attending cardiologist will be 
consulted for any patients who have a heart rate that exceeds 85% of age predicted 
maximum heart rate during at-home exercise. Patients will be encouraged to continue 
compliance with home-medications (e.g., beta blockers). It is important to emphasize that 
moderate-intensity home-based physical activity is recommended for patients with 
cardiovascular disease. In the unlikely event of any suspected or actual imminent cardiac 
event, patients will be instructed to call 911 for immediate medical care. Any medically 
related incidents will be reported immediately to patients’ attending cardiologist at the 
RWJ University Hospital Cardiac Rehabilitation Program. 
 
• 
Risk of Harm from an Intervention on a Subject with an Existing Condition 
 
Panic attacks/increased somatic sensations from exercise sensitivity treatment 
 
Risks. In this type of patient population, the risk of panic attacks or subjective somatic 
distress is present, which may be exacerbated from interoceptive exposures (i.e., 
moderate-intensity walking). 
Minimization. Patients will be provided with information about common bodily sensations 
that accompany panic attacks: e.g., increased heart rate, sharp/stabbing chest pain that 
is temporary (last 5-10 seconds), localized pain to one small area, pain 
relieved/worsened when changing body position. Patients will be provided with 
psychoeducation about what sensations are potentially indicative of a true cardiac 
emergency: e.g., escalating crushing pain in chest reaching maximum severity for several 
minutes; constant pain, pressure, fullness or aching in chest; radiating pain from chest to 
other areas (arms, abdomen, back, shoulders, neck, throat, or jaw). Patient’s specific 
feared bodily sensations will be reviewed prior to treatment initiation to assist the 
therapist and patient with appropriate planning for addressing symptoms if they arise. 
Patients will be fully informed about the nature and intention of exposure treatment (to 
intentionally elicit feared yet benign uncomfortable bodily sensations) and will be given 
the opportunity to ask questions. Patients will likely experience a range of sensations 
during brisk walking (muscle tightness, increased heart rate, shortness of breath). These 
symptoms are temporary, not harmful (although may be fearful). It is worth noting that the 
experience of a panic attack is not harmful or dangerous, and symptoms peak/dissipate 
typically within 20-30 minutes. While there is risk for experiencing these sensations, 
engagement in exposure techniques and physical activity is the treatment for anxiety and 
walking is also critical for heart health. Thus, while intervention techniques can initially 
elicit anxiety/somatic sensations, repeated practice and engagement will serve to 
decrease anxiety and likelihood of fearful responses to bodily symptoms. Dr. Farris has 
extensive experience in conducting interoceptive exposure interventions, including use of 
more intensive forms of interoceptive exposure than proposed in this study. Exposures 
are safe, typically well-tolerated by patients, and no significant adverse events have 
resulted from Dr. Farris’ prior use of these interventions. Patients will be informed that 
they can stop exposures at any time. Continuing participation of the patients will remain 
voluntary, and patients will remain free to terminate participation at any time.  
 
• 
Other Foreseeable Risks of Harm 
 
Breach of Confidentiality 
 
Risks. The risk of loss of privacy is judged to be minimal. 

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Minimization. Breach of confidentiality is highly unlikely because all data are identified 
only by numeric code and are stored in locked file cabinets. A master list of names and 
numbers is kept in a separate location and is used to facilitate the collection of follow-up 
data. Only senior grant staff will have access to the master list linking names and code 
numbers. Clinically important assessment data (e.g., suicidal ideation) will be made 
available to clinical staff to coordinate services more effectively. All staff will be fully 
trained in relevant ethical principles and procedures, particularly around confidentiality. 
All assessment and treatment procedures will be closely supervised by the project’s 
professional staff. All audiotapes will be erased upon completion of data analysis. No 
personal participant information will be presented in any publication or presentations 
resulting from this research.  
 
B. Assessment of Social Behavior Considerations 
 
Depression or suicidal ideation  
 
Risks. The risk of depression or suicidal ideation may be present in this patient population.  
Minimization. All research staff who have direct involvement with patients will be fully trained 
by the principal investigator in procedures for assessment and intervention in cases where 
significant depression or suicidal ideation is expressed. In such cases, research staff will also 
immediately contact the principal investigator (Dr. Farris) who will always be on-call. 
Appropriate clinical action will be taken in such circumstances, which may include 
hospitalization and/or referral to another level of clinical care. These are standard 
procedures, and these services are readily available at Rutgers Behavioral Health Care in 
Piscataway, NJ.  
 
C. Minimizing Risks of Harm 
• 
Certificate of Confidentiality 
This study is an NIH-funded study for which a Certificate of Confidentiality is automatically 
issued to protect the data obtained.  
• 
Provisions to Protect the Privacy Interests of Subjects 
All data from questionnaires and the Fitbit Inspire 2 data will be stored confidentially, using a 
secure web server with a 128-bit encryption. Participants will be identified with a unique 
patient identification number not utilized outside research purposes. Consent forms 
containing identifying information will be locked securely and filed separately from the actual 
data. Information linking participant IDs to their name will be kept in a password protected 
computer file only accessible by senior research staff. When applicable, hard-copy data will 
also be locked away and will not have any personal identifiers. Audio-recorded data will be 
stored in a locked filing cabinet and the tapes will be destroyed after the data is analyzed. 
Data will be aggregated through qualitative analysis. Data from medical records kept securely 
at the Cardio Metabolic Institute is only accessed by trained clinicians working at the site. 
 
D. Potential Direct Benefits to Subjects 
The risks to patients in the HEC are expected to be minimal given that they will be receiving their 
typically prescribed exercise regimen during CR sessions and will not assigned any additional 
physical activity goals by study staff. Additionally, the risks to patients randomized to BE-FIT are 
judged to be acceptable relative to the anticipated benefits. By participating in this clinical 
research project, patients may benefit from the additional intervention that they will receive. In 
addition, all patients will receive a Fitbit Inspire 2 sports watch for exercise tracking, which can 
also help to increase activity levels. The risks of significant psychiatric symptoms (panic attacks, 
exacerbated anxiety/fear, depression, suicidal ideation) are inherent in this patient population. 
However, exacerbated short-term anxiety and panic attacks are the only side effects we 
anticipate due to this intervention. These symptoms are short-lived, leave no long-term effects on 
physical or mental health, and the risk of experiencing them is no more acute than that of 
standard cardiac rehabilitation. Our intervention program will provide potential opportunities to 
identify and respond to symptoms of exercise sensitivity that might remain undetected if patients 

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were not in this study. The risks associated with participation in brisk at-home walking are 
minimal. Given this level of risk(s) to the patients and the likelihood that many will benefit from the 
additional treatment (or from the additional assessment contacts) and the even greater possibility 
of benefits to the larger population of patients in cardiac rehabilitation, the risk/benefits ratio 
seems favorable.  
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
      N/A 
 
5.2 Family Educational Rights and Privacy Act (FERPA) 
      N/A 
 
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
      N/A 
 
5.4 General Data Protection Regulation (GDPR) 
      N/A 
 
5.5 NJ Access to Medical Research Act (Surrogate Consent) 
      N/A 
 
6.0 Data Management Plan 
 
6.1 Data Analysis 
Aims 1 and 2 will be evaluated using generalized linear mixed models and structural equation 
modeling (SEM), an extension of general linear models allowing for multi-level data with non-normal 
distributions. 63,64 With respect to evaluating main effects of experimental conditions on exercise 
adherence, each participant will provide up to five assessments (baseline, EOT, Wk 12, Wk 18, Wk 
24 follow-up data). Hypotheses will be tested using specific contrast vectors, using a general linear 
hypothesis framework. 65 Aim 3 will utilize an alternative approach which has arisen out of the 
structural equation modeling (SEM) tradition. 66,67 Linear and non-linear growth curve models and 
growth mixture models can accommodate non-normal distributions, count outcomes, zero-inflation, 
and two-part hurdle models. These approaches model individual trajectories and offer relatively 
straightforward means of addressing missing data with state-of-the-art strategies including maximum 
likelihood (i.e., FIML) or multiple imputation. The SEM approach can accommodate models 
simultaneously assessing multiple distinct mediation pathways and can readily address the limitations 
inherent in regression-based conditional process models.68  
 
Aim 1. The primary outcome of interest in Aim 1, overall minutes of exercise, will be evaluated as a 
function of a dummy coded variable representing BE-FIT and HEC with HEC as the reference group. 
Time X BE-FIT will provide a direct test of differences in change between BE-FIT and HEC groups in 
overall minutes of exercise. Secondary outcomes of interest, changes in overall steps/day and CR 
adherence, will be modeled using the same framework with CR (vs. non-CR) days examined as an 
effect modifier. We will utilize a Bonferroni correction with Šídák adjustment for correlated outcomes 
to reduce alpha inflation associated with multiple outcomes (i.e., number of CR sessions attended, 
exercise on CR days and lifestyle PA (exercise on non-CR days)).  For these analyses, each 
participant will provide up to 5 repeated measures, yielding up to 730 Level 1 cases (repeated-
measures across 146 Level 2 cases). Assuming outcomes follow a negative binomial distribution with 
a natural log link, the following model will be the basis for evaluating intervention effects as specified 
in Aim 1 hypotheses: 
Level 1: 
log (E[DV]ti) = p0i + p1i(Time)ti + εti  
εti ~ N((0, 
)
)  
Level 2: 
p0i = b00 + b01(BE-FIT)i +b +r00i  
p1i = b10 + β11(BE-FIT)i + r10i 
2
e
s
I
2
e
s
I

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where t indexes repeated-measures and i indexes participants. BE-FIT reflects difference 
between conditions. DVti represents the outcome for each individual at each time point. Timeti 
measures weeks since baseline.  
 
Aim 2 will be evaluated examining target engagement outcomes (i.e., exercise anxiety, anxiety 
cognitions, avoidance and safety behavior use, vagal tone and flexibility) as a function of a dummy 
coded variable representing BE-FIT and HEC with HEC reference group. Time X BE-FIT outcomes 
will provide direct tests of differences in change between BE-FIT and HEC groups. We will again 
utilize a Bonferroni correction with Šídák adjustment for correlated outcomes to reduce alpha inflation 
associated with multiple outcomes (i.e., exercise anxiety, anxiety cognitions, avoidance and safety 
behavior use, vagal tone, and flexibility). 
 
Aim 3 will evaluate mediators of intervention effects. We will use SEM to test the hypothesis that 
decreases in exercise anxiety and its associated components (reduced cognitive bias, safety 
behaviors; increased cardiac vagal control), at EOT and Wk 12 will mediate the association between 
BE-FIT (vs. HEC) and PA outcomes at later follow-ups (i.e., Wks 18 and 24). Following the 
recommendations of Fritz and MacKinnon, we will use the bias-corrected bootstrap confidence 
interval estimates to test the mediation hypotheses. We will use MPlus statistical software to estimate 
the structural equation models. Power to test mediation depends on the effect of treatment on the 
mediator (path a) and the effect of the mediator on the outcome (path b). Fritz and MacKinnon 
describe a standardized effect of .14 as a small effect, and .39 as a medium effect. Our power 
estimate is generally consistent with the sample size requirements suggested by Fritz and 
MacKinnon in their simulation.  
 
6.2 Data Security 
All data will be completed confidentially, using a secure web server with a 128-bit encryption. 
Participants will be identified with a unique patient identification number not utilized outside research 
purposes. Consent forms containing identifying information will be locked securely and filed 
separately from the actual data. Information linking participant IDs to their name will be kept in a 
password protected computer file. When applicable, hard-copy data will also be locked away and will 
not have any personal identifiers. Once audio recordings of exit interviews are analyzed by research 
staff, they will be destroyed. Until that point, they will be under lock and key. 
 
6.3 Data and Safety Monitoring 
N/A 
 
6.4 Reporting Results 
 
A. Individual Subjects’ Results  
Full study results will only be shared with study participants if they contact Dr. Farris and express 
their desire to receive these results at the end of the study. Results from Fitbit activity monitoring 
will be shared with participants.  
 
B. Professional Reporting 
Results from this study, negative or positive, will be shared with the greater scientific community 
via manuscripts published in peer-reviewed journals, as well as through posters and presentations 
at relevant scientific conferences.  
 
6.5 Secondary Use of the Data    
After data have been collected and study results published, de-identified data will be made available 
to other qualified researchers upon request, on a CD or other electronic means compatible with our 
systems. The request will be evaluated by the PIs to ensure that it meets reasonable standards of 
scientific integrity. We may also choose to share de-identified data with colleagues/collaborators at 
other institutions. We will work on the data dictionary throughout the study. We will submit primary 
results for publication by the end of the project period and will have final de-identified datasets and 
data dictionaries available by the end of the project period.   

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7.0 Research Repositories – Specimens and/or Data 
As previously described, de-identified data, apart from audio interview recordings, will be kept electronically 
by the study PI to be analyzed for future manuscripts and presentations. Recorded interviews will be 
destroyed. 
 
8.0 Approvals/Authorizations 
 
N/A  
 
9.0 Bibliography 
 
1.  
Drewnowski A, Monsen E, Birkett D, et al. Health screening and health promotion programs for the 
elderly. Dis Manag Heal Outcomes. 2003;11(5):299-309. doi:10.2165/00115677-200311050-
00003 
2.  
Peel NM, McClure RJ, Bartlett HP. Behavioral determinants of healthy aging. Am J Prev Med. 
2005;28(3):298-304. doi:10.1016/j.amepre.2004.12.002 
3.  
Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, et al. Exercise and physical activity for older 
adults. Med Sci Sports Exerc. 2009;41(7):1510-1530. doi:10.1249/MSS.0b013e3181a0c95c 
4.  
Strait JB, Lakatta EG. Aging-Associated Cardiovascular Changes and Their Relationship to Heart 
Failure. Heart Fail Clin. 2012;8(1):143-164. doi:10.1016/j.hfc.2011.08.011 
5.  
Paneni F, Diaz Cañestro C, Libby P, Lüscher TF, Camici GG. The Aging Cardiovascular System: 
Understanding It at the Cellular and Clinical Levels. J Am Coll Cardiol. 2017;69(15):1952-1967. 
doi:10.1016/j.jacc.2017.01.064 
6.  
Kovacic JC, Moreno P, Nabel EG, Hachinski V, Fuster V. Cellular senescence, vascular disease, 
and aging: Part 2 of a 2-part review: Clinical vascular disease in the elderly. Circulation. 
2011;123(17):1900-1910. doi:10.1161/CIRCULATIONAHA.110.009118 
7.  
Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forcasing the future of cardiovascular disease in 
the United States. Circulation. 2011;123(8):933-944. doi:10.1161/CIR.0b013e31820a55f5 
8.  
Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics-2013 update: A report 
from the American Heart Association. Circulation. 2013;127:e6-e245. 
doi:10.1161/CIR.0b013e31828124ad 
9.  
North BJ, Sinclair DA. The intersection between aging and cardiovascular disease. Circ Res. 
2012;110(8):1097-1108. doi:10.1161/CIRCRESAHA.111.246876 
10.  
Arnold AM, Psaty BM, Kuller LH, et al. Incidence of cardiovascular disease in older Americans: 
The Cardiovascular Health Study. J Am Geriatr Soc. 2005;53(2):211-218. doi:10.1111/j.1532-
5415.2005.53105.x 
11.  
Yazdanyar A, Newman AB. The Burden of Cardiovascular Disease in the Elderly: Morbidity, 
Mortality, and Costs. Clin Geriatr Med. 2009;25(4):563-577. doi:10.1016/j.cger.2009.07.007 
12.  
Mozaffarian D, Benjamin E, Go A, et al. Heart disease and stroke statistics—2016 update: a report 
from the American Heart Association. Circulation. 2016;133(4):e38-e360. 
13.  
Kemi O, Hoydal M, Macquaide N, Haram P, Koch L, Britton S. The effect of exercise training on 
transverse tubules in normal, remodeled, and reverse remodeled hearts. J Cell Physiol. 
2011;226:2235-2243. doi:10.1002/jcp.22559 
14.  
Tjønna AE, Rognmo Ø, Bye A, Stølen TO, Wisløff U. Time course of endothelial adaptation after 
acute and chronic exercise in patients with metabolic syndrome. J Strength Cond Res. 
2011;25(9):2552-2558. 
15.  
Campkin L, Boyd J, Campbell D. Coronary artery disease patient perspectives on exercise 
participation. J Cardiopulm Rehabil Prev. 2017;37(5):305–14. 
16.  
Borg S, Öberg B, Leosdottir M, Lindolm D, Nilsson L, Bäck M. Factors associated with non-
Attendance at exercise-based cardiac rehabilitation. BMC Sports Sci Med Rehabil. 2019;11(1):1-
10. doi:10.1186/s13102-019-0125-9 
17.  
Schopfer DW, Forman DE. Cardiac Rehabilitation in Older Adults. Can J Cardiol. 
2016;32(9):1088-1096. doi:10.1016/j.cjca.2016.03.003 
18.  
Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J 

Rutgers MOP Version 1.0 January 2022  
    
Page 64 of 107 
 
 
 
Med. 2001;345(12):892-902. doi:10.1056/NEJMra001529 
19.  
Brown TM, Hernandez AF, Bittner V, et al. Predictors of cardiac rehabilitation referral in coronary 
artery disease patients: findings from the American Heart Association’s Get With The Guidelines 
Program. J Am Coll Cardiol. 2009;54(6):515-521. doi:10.1016/j.jacc.2009.02.080 
20.  
Beswick AD, Rees K, West RR, et al. Improving uptake and adherence in cardiac rehabilitation: 
literature review. J Adv Nurs. 2005;49(5):538-555. doi:10.1111/j.1365-2648.2004.03327.x 
21.  
Clark AM, King-Shier KM, Spaling MA, et al. Factors influencing participation in cardiac 
rehabilitation programmes after referral and initial attendance: qualitative systematic review and 
meta-synthesis. Clin Rehabil. 2013;27(10):948-959. doi:10.1177/0269215513481046 
22.  
Audelin MC, Savage PD, Ades PA. Changing clinical profile of patients entering cardiac 
rehabilitation/ secondary prevention programs: 1996 to 2006. J Cardiopulm Rehabil Prev. 
2008;28(5):299-306. doi:10.1097/01.HCR.0000336139.48698.26 
23.  
Gaalema DE, Savage PD, Leadholm K, et al. Clinical and Demographic Trends in Cardiac 
Rehabilitation: 1996-2015. J Cardiopulm Rehabil Prev. 2019;39(4). 
doi:10.1097/HCR.0000000000000390 
24.  
Mason JE, Faller YN, LeBouthillier DM, Asmundson GJG. Exercise anxiety: A qualitative analysis 
of the barriers, facilitators, and psychological processes underlying exercise participation for 
people with anxiety-related disorders. Ment Health Phys Act. 2019;16(November 2018):128-139. 
doi:10.1016/j.mhpa.2018.11.003 
25.  
Aikens JE, Zvolensky MJ, Eifert GH. Differential fear of cardiopulmonary sensations in emergency 
room noncardiac chest pain patients. J Behav Med. 2001;24(2):155-167. 
doi:10.1023/A:1010710614626 
26.  
Zvolensky MJ, Eifert GH, Feldner MT, Leen-Feldner E. Heart-focused anxiety and chest pain in 
postangiography medical patients. J Behav Med. 2003;26(3):197-209. 
doi:10.1023/A:1023456419736 
27.  
Khalsa SS, Lapidus RC. Can interoception improve the pragmatic search for biomarkers in 
psychiatry? Front Psychiatry. 2016;7(JUL):1-19. doi:10.3389/fpsyt.2016.00121 
28.  
Jeejeebhoy FM, Dorian P, Newman DM. Panic disorder and the heart: a cardiology perspective. J 
Psychosom Res. 2000;48(4):393-403. doi:10.1016/S0022-3999(99)00103-8 
29.  
Korczak DJ, Goldstein BI, Levitt AJ. Panic disorder, cardiac diagnosis and emergency department 
utilization in an epidemiologic community sample. Gen Hosp Psychiatry. 2007;29(4):335-339. 
doi:10.1016/j.genhosppsych.2007.03.006 
30.  
Farris SG, Abrantes AM, Bond DS, Stabile LM, Wu WC. Anxiety and Fear of Exercise in 
Cardiopulmonary Rehabilitation: PATIENT AND PRACTITIONER PERSPECTIVES. J Cardiopulm 
Rehabil Prev. 2019;39(2):E9-E13. doi:10.1097/HCR.0000000000000401 
31.  
Farris SG, Burr EK, Kibbey MM, Abrantes AM, DiBello AM. Development and initial validation of 
the Exercise Sensitivity Questionnaire. Ment Health Phys Act. 2020;19. 
doi:10.1016/j.mhpa.2020.100346 
32.  
Eifert GH, Thompson RN, Zvolensky MJ, et al. The Cardiac Anxiety Questionnaire: Development 
and preliminary validity. Behav Res Ther. 2000;38(10):1039-1053. doi:10.1016/S0005-
7967(99)00132-1 
33.  
Ozyemisci-Taskiran O, Demirsoy N, Atan T, et al. Development and Validation of a Scale to 
Measure Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD). Arch Phys Med 
Rehabil. 2020;101(3):479-486. doi:10.1016/J.APMR.2019.09.001 
34.  
Goodson JT, Haeffel GJ, Raush DA, Hershenberg R. The Safety Behavior Assessment Form: 
Development and Validation. J Clin Psychol. 2016;72(10):1099-1111. doi:10.1002/jclp.22325 
35.  
Cornelius T, Agarwal S, Garcia O, Chaplin W, Edmondson D, Chang BP. Development and 
Validation of a Measure to Assess Patients’ Threat Perceptions in the Emergency Department. 
Acad Emerg Med. 2018;25(10). doi:10.1111/acem.13513 
36.  
Smout M, Davies M, Burns N, Christie A. Development of the Valuing Questionnaire (VQ). J 
Context Behav Sci. 2013;3(3):164-172. doi:10.1016/j.jcbs.2014.06.001 
37.  
Carleton RN, Norton MAPJ, Asmundson GJG. Fearing the unknown: A short version of the 
Intolerance of Uncertainty Scale. J Anxiety Disord. 2007. doi:10.1016/j.janxdis.2006.03.014 
38.  
Schmidt NB, Richey JA, Fitzpatrick KK. Discomfort intolerance: Development of a construct and 
measure relevant to panic disorder. J Anxiety Disord. 2006;20(3):263-280. 
doi:10.1016/j.janxdis.2005.02.002 

Rutgers MOP Version 1.0 January 2022  
    
Page 65 of 107 
 
 
 
39.  
Olatunji BO, Deacon BJ, Abramowitz JS, Valentiner DP. Body Vigilance in Nonclinical and Anxiety 
Disorder Samples: Structure, Correlates, and Prediction of Health Concerns. Behav Ther. 
2007;38(4):392-401. doi:10.1016/j.beth.2006.09.002 
40.  
Taylor S, Zvolensky MJ, Cox BJ, et al. Robust dimensions of anxiety sensitivity: development and 
initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007;19(2):176-188. 
doi:10.1037/1040-3590.19.2.176 
41.  
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety 
disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097. doi:10.1001/archinte.166.10.1092 
42.  
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J 
Gen Intern Med. 2001;16(9):606-613. 
43.  
Farris SG, Bond DS, Wu W-C, Stabile LM, Abrantes AM. Anxiety sensitivity and fear of exercise in 
patients attending cardiac rehabilitation. Ment Health Phys Act. 2018;15:22-26. 
doi:10.1016/j.mhpa.2018.06.005 
44.  
Farris SG, Burr EK, Kibbey MM, Abrantes AM, DiBello AM. Development and Initial Validation of 
the Exercise Sensitivity Questionnaire (ESQ). Ment Health Phys Act. 2020;19:100346. 
45.  
Craske MG, Kircanski K, Zelikowsky M, Mystkowski J, Chowdhury N, Baker A. Optimizing 
inhibitory learning during exposure therapy. Behav Res Ther. 2008;46(1):5-27. 
doi:10.1016/j.brat.2007.10.003 
46.  
Barlow DH, Craske MG. Mastery of Your Anxiety and Panic. Workbook. 4th ed. New York: Oxford 
University Press; 2007. 
47.  
Smits JAJ, Berry AC, Tart CD, Powers MB. The efficacy of cognitive-behavioral interventions for 
reducing anxiety sensitivity: A meta-analytic review. Behav Res Ther. 2008;46(9):1047-1054. 
doi:10.1016/j.brat.2008.06.010 
48.  
Nasreddine Z, Phillips N, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief 
screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695–699. doi:doi: 
10.1111/j.1532-5415.2005.53221.x 
49.  
Golightly Y, Allen K, Ambrose K, et al. Physical Activity as a Vital Sign: A Systematic Review. Prev 
Chronic Dis. 2017;14:170030. doi:http://dx.doi.org/10.5888/pcd14.170030external icon 
50.  
Kibbey MM, DiBello AM, Babu AA, Farris SG. Validation of the Valuing Questionnaire (VQ) in 
adults with cardiovascular disease and risk. J Context Behav Sci. 2020;17:144-151. 
doi:10.1016/j.jcbs.2020.07.006 
51.  
Thayer J, Åhs F, Fredrikson M, Sollers J, Wager T. A meta-analysis of heart rate variability and 
neuroimaging studies: Implications for heart rate variability as a marker of stress and health. 
Neurosci Biobehav Rev. 2012;36(2):747-756. 
52.  
Thayer J, Lane R. A model of neurovisceral integration in emotion regulation and dysregulation. J 
Affect Disord. 2000;61(3):201-216. 
53.  
Todaro JF, Shen BJ, Raffa SD, Tilkemeier PL, Niaura R. Prevalence of anxiety disorders in men 
and women with established coronary heart disease. J Cardiopulm Rehabil Prev. 2007;27(2):86-
91. doi:10.1097/01.HCR.0000265036.24157.e7 
54.  
Tudor-Locke C, Bassett Jr. D. How many steps/day are enough? Preliminary pedometer indices 
for public health. Sport Med. 2004;34(1):1-8. 
55.  
2018 Physical Activity Guidelines Advisory Committee. 2018 Physical Activity Guidelines Advisory 
Committee Scientific Report. Washington, DC; 2018. 
56.  
Lee IM, Shiroma EJ, Kamada M, Bassett DR, Matthews CE, Buring JE. Association of Step 
Volume and Intensity with All-Cause Mortality in Older Women. JAMA Intern Med. 
2019;179(8):1105-1112. doi:10.1001/jamainternmed.2019.0899 
57.  
Muhtadie L, Koslov K, Akinola M, Mendes W. Vagal flexibility: A physiological predictor of social 
sensitivity. J Pers Soc Psychol. 2015;109(1):106-120. 
58.  
Berntson GG, Thomas Bigger J, Eckberg DL, Grossman P, Kaufmann PG, Malik M. Heart rate 
variability: Origins, methods, and interpretive caveats. Psychphysiology. 1977;34:623-648. 
59.  
Sherwood A, Allen M, Fahrenberg J, Kelsey R, Lovallo W, Van Doornen L. Methodological 
guidelines for impedance cardiography. Psychophysiology. 1990;27(1):1-23. 
60.  
Shapiro D, Jamner L, Lane J, et al. Blood pressure publication guidelines. Psychophysiology. 
1996;33(1):1-2. 
61.  
Borrelli B, Sepinwall D, Ernst D, et al. A new tool to assess treatment fidelity and evaluation of 
treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol. 

Rutgers MOP Version 1.0 January 2022  
    
Page 66 of 107 
 
 
 
2005;73(5):852-860. doi:10.1037/0022-006X.73.5.852 
62.  
Lambert J, Greaves C, Farrand P, Cross R, Haase A, Taylor A. Assessment of fidelity in individual 
level behaviour change interventions promoting physical activity among adults: a systematic 
review. BMC Public Heal. 2017;17(1):765. doi:10.1186/s12889-017-4778-6 
63.  
Atkins DC, Baldwin S, Zheng C, Gallop RJ, Neighbors C. A tutorial on count regression and zero-
altered count models for longitudinal substance use data. 2013;27:166-177. 
64.  
Hedeker D, Gibbons RD. Longitudinal Data Analysis. Hoboken, NJ: John Wiley & Sons.; 2006. 
65.  
Fox J. Applied Regression Analysis and Generalized Linear Models. Sage Publications; 2008. 
66.  
Duncan SC, Duncan TE, Strycker LA. Alcohol use from ages 9 to 16: A cohort-sequential latent 
growth model. Drug Alcohol Depend. 2006;81(1):71-81. 
67.  
Little TD. Longitudinal Structural Equation Modeling. (Press. G, ed.).; 2013. 
68.  
Stride CB, Gardner S, Catley N, Thomas F. Mplus Code for the Mediation, Moderation, and 
Moderated Mediation Model Templates from Andrew Hayes’ PROCESS Analysis Examples.; 
2015. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix B - Protocol Deviation/Violation Log 
Protocol Title: ___________________  
Protocol Number: _________________
Site:   
                                               Principal Investigator:   
 
 
Protocol 
Deviation/ 
Violation Code: 
Participant 
Initials 
Participant 
ID# 
Date Deviation / 
Violation 
Occurred: 
Date Protocol 
Deviation 
/ Violation Form 
Contact 
Person 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAMPLE PROTOCOL DEVIATION / VIOLATION CODES 
Consent Form: 
1. 
Missing or not obtained 
2. 
Not signed and dated by participant 
3. 
Does not contain all required signatures 
4. 
Outdated, current IRB-approved version not used 
5. 
Not protocol specific. 
6. 
Does not include updates or information required by 
the IRB 
Randomization: 
7. 
Ineligible participant enrolled and/or randomized 
8. 
Participant is randomized prior to determining 
whether eligible for study 
9. 
Occurs outside protocol window 
 
 
 
IRB: 
10. Not reporting a serious complication within 24 hours 
11. Approvals not kept up to date 
12. Enrollment and/or treatment occurs prior to IRB 
approval or during period when “on hold” 
13. Reportable serious adverse events not reported to 
IRB 
Participant: 
14. Receives wrong treatment 
15. Visits occur outside expected follow-up window 
16. Entered into another study 
Study Data and/or Forms: 
17. Missing data and/or forms 
18. Missing radiology and/or operative reports 
19. Forms or data not sent from clinical site to 
coordinating center 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C - Consent Forms 
 
CONSENT TO TAKE PART IN A RESEARCH STUDY 
 
 
Title of Study: Behavioral Factors Influencing Treatment Outcomes in Cardiac 
Rehabilitation (BE-FIT) 
 
Principal Investigator: Samantha G. Farris, Ph.D. 
 
Co-Investigator: Teresa Leyro, Ph.D., Brandon Alderman, Ph.D, Michael Steinberg, 
M.D. 
 
 
STUDY SUMMARY: This consent form is part of an informed consent process for a 
research study and it will provide information that will help you decide whether you 
want to take part in this study.  It is your choice to take part or not.  
 
The purpose of the research is to examine how different supplemental treatments 
enhance cardiac rehabilitation outcomes. You will be randomly assigned to 1 of 2 
supplemental treatments. If you take part in the research, you will be asked to 
participate in an interventional research treatment, in which you will meet with a 
behavior coach for 6 sessions. You will also complete baseline and follow-up 
questionnaires, undergo measurement of heart rate and blood pressure activity, and 
wear a physical activity tracker (Fitbit). Your time in the study will take around 24 
weeks, or 6 months.  
 
Possible harms or burdens of taking part in the study may be distress during the 
assessments as we will ask you about your thoughts and emotional symptoms, 
discomfort during physiological tasks, skin irritation from wearing the sports watch, 
bodily discomfort during physical activity. Possible benefits of taking part may be 
improvement in mental and physical health through education in how to maintain and 
engage in exercise behavior. Your feedback may also provide researchers with new 
information to improve our intervention to treat people in cardiac rehabilitation more 
effectively. However, there may be no direct benefit to you for participating. 
 
Your alternative to taking part in the research study is not to take part in it. You will 
complete the regular cardiac rehabilitation at the RWJ Cardiac Rehabilitation Program 
if you choose not to participate. There will be no penalty to you if you choose not to 
participate in this study and you will not lose any benefits you are entitled to as a 
patient at the RWJ Cardiac Rehabilitation Program.  
 
 
The information in this consent form will provide more details about the research study 
and what will be asked of you if you choose to take part in it. If you have any questions 
now or during the study, if you choose to take part, you should feel free to ask them and 

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should expect to be given answers you completely understand.  After your questions 
have been answered and you wish to take part in the research study, you will be asked 
to sign this consent form. You are not giving up any of your legal rights by agreeing to 
take part in this research or by signing this consent form. 
 
Who is conducting this study? 
 
Dr. Farris is the Principal Investigator of this research study from the Department of 
Psychology at Rutgers University.  A Principal Investigator has the overall responsibility 
for the conduct of the research. However, there are often other individuals who are part 
of the research team. Dr. Farris is collaborating with co-investigator Teresa Leyro from 
the Rutgers Department of Psychology. We are doing this work in conjunction with your 
treatment team at the Robert Wood Johnson University Hospital Cardiac Rehabilitation 
Program. Dr. Farris or another member of the study team will also be asked to sign this 
informed consent. You will be given a copy of the signed consent form to keep.  
 
Dr. Farris can be contacted at:  
 
1 Spring Street, Suite 200 
Department of Psychology,  
Rutgers University,  
New Brunswick, NJ 08901  
Email: samantha.farris@rutgers.edu 
 
The Principal investigator or another member of the study team will also be asked to 
sign this informed consent.  You will be given a copy of the signed consent form to 
keep. 
 
 
 
Sponsor of the Study: This study is being sponsored by the National Institutes of 
Health, National Institute on Aging. 
 
 
 

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Why is this study being done? 
 
 
 
The purpose of this study is to promote healthy aging. We aim to discover whether there 
are any differences in outcomes between patients who receive two different types of 
interventions.  
 
Who may take part in this study and who may not? 
 
Your cardiologist at RWJ Cardiac Rehabilitation Program has already cleared you as 
physically capable of participation in this study. You must also have had a recent (within 
the past 3 months) diagnosis of myocardial infarction, percutaneous coronary 
intervention (stent or revascularization), chronic angina, or valve surgery (in other 
words, a recent heart attack or some medical procedure to improve the function of your 
heart or arteries). There are also baseline mental health criteria that must be met in 
order to participate in the study based on measures you completed during orientation 
with the cardiac rehabilitation nurse.People not attending outpatient RWJ are not able to 
participate in this study. 
 
Why have I been asked to take part in this study? 
 
You have been asked to participate in this study because you are a patient in cardiac 
rehabilitation at the RWJ Cardiac Rehabilitation Program and your cardiologist has 
assessed that you are physically capable of participating based on your medical 
records.   
 
How long will the study take and how many subjects will take part? 
 
A total of 146 patients attending cardiac rehabilitation will take part in our treatment 
study. The study will take place over the course of 24 weeks or approximately 6 months. 
The first week will be a 7-day baseline assessment of physical activity with no treatment 
sessions or time commitment outside of your normal daily routine. During the following 
three weeks, you will be asked to attend 6 treatment sessions (2x weekly). Each 
session is approximately 45 minutes long. You will also be asked to wear a FitBit  
throughout the course of the study to monitor your physical activity levels. After you 
complete all treatment sessions, you will be asked to return for 4 follow-up visits.  
 
What will I be asked to do if I take part in this study? 
 
If you consent to this study and are eligible based on a questionnaire, you will complete 
a few brief baseline questionnaires (~20-25 minutes) and we will obtain additional 
information from your medical record at RWJ Cardiac Rehabilitation Program on your 
medical history, cardiac diagnosis, and medication treatment.  
 
We will also ask you to complete an electrocardiogram (ECG) and impedance 
cardiography (ICG), which are both non-invasive procedures used to record the 
electrical and mechanical activity of the heart (~30-45 minutes). Electrodes (sensors 

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with sticky gel) will be placed on your chest and limbs, and these electrodes will send 
information about your heart activity to a computer monitor to be recorded and 
measured. The risks associated with this procedure are minimal, but in very rare cases 
skin irritation may occur on electrode sites. You will also complete an exercise test, 
during which we will ask you how you feel. This exercise test is a required component of 
your orientation for rehab at the RWJ Cardiac Rehabilitation Center. Then we will ask 
you to wear a Fitbit activity tracker on your wrist that measures your movement 
throughout the day. This Fitbit will give us information about your daily physical activity 
levels. There will be one week after the baseline assessment where you wear the Fitbit 
to measure your standard amount of physical activity.  
 
After seven days, you will be randomly assigned to receive one of two interventions at 
the RWJ Cardiac Rehabilitation Program. In other words, you will be assigned to one of 
two treatments based on a flip of a coin. Both treatments are intended to help you live a 
heart-healthy lifestyle, and this study aims to find out which treatment is most helpful. 
Your treatment sessions will take place on the same day as your cardiac rehabilitation 
sessions at the RWJ Cardiac Rehabilitation Program. The intervention will occur in 6 
one-to-one sessions with a clinician. Sessions will be audio recorded. Sessions will 
focus on information about health and strategies to increase positive health behaviors. 
You will also be asked to wear the Fitbit on your wrist daily to capture your physical 
activity levels throughout the study, and study staff will have access to the data 
recorded by the FitBit for research purposes.  
 
At the end of your treatment, you will be asked to complete an end-of-treatment 
assessment, during which you will complete questionnaires and the same physiological 
assessments from your baseline visit (ECG/ICG). You will also be asked to return for 
three follow-up visits at Weeks 12, 18, and 24 of your study enrollment. During the 12-
Week visit, you willbe asked to complete the questionnaires and ECG/ICG again. 
During visits for Weeks 18 and 24, we will ask you to complete the questionnaires only. 
 
What are the risks of harm or discomforts I might experience if I take part in this 
study? 
 
The risks of participating in this study are minimal. 
• Distress during assessments: During the assessments we will ask you about 
your thoughts, feelings, behaviors, and emotional symptoms. It is possible that 
talking about this information may increase distress or discomfort. You may 
choose not to answer questions if you find them upsetting. 
• Irritation from the physiological assessments: The electrocardiogram and/or 
impedance cardiography) may cause skin irritation at the site where electrodes 
were placed. The irritation will not result in any permanent sensations or harm to 
your skin.  
• Irritation from activity tracker: The Fitbit may cause irritation to the skin, and you 
should discontinue use and notify study staff if this happens to you. The irritation 
will not cause any permanent sensations or harm to your skin. 

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• Bodily discomfort during physical activity: Physical activity is healthy and 
recommended by the RWJ Cardiac rehab program, however you may experience 
some discomfort. During intervention sessions, you may be asked to engage in 
various types of physical activities. Physical activities can produce sensations 
like heart rate speeding up, feeling out of breath, or sweating. In addition to 
wearing the FitBit, your counselor and cardiac rehab team will work together and 
tailor your exercise plan. This discomfort won’t be any higher than that 
experienced with other physical activities assigned to patients in cardiac 
rehabilitation and is associated with behavior that promotes overall health. 
 
Are there any benefits to me if I choose to take part in this study? 
 
You may benefit from this study in terms of improvement in mental and physical health 
through education informing you how to maintain and engage in positive health 
behaviors. Additionally, your feedback will provide researchers with tools to modify our 
intervention procedures to treat people more effectively in cardiac rehabilitation and 
therefore result in better treatment outcomes. However, there may be no direct benefit 
to you for participating. 
 
What are my alternatives if I do not want to take part in this study? 
 
There are no alternative treatments available. Your alternative is not to take part in this 
study and complete the standard cardiac rehabilitation at the RWJ Cardiac 
Rehabilitation Program if you choose not to participate. There will be no penalty to you if 
you choose not to participate in this study and you will not lose any benefits you are 
entitled to as a patient at the RWJ Cardiac Rehabilitation Program.  
 
How will I know if new information is learned that may affect whether I am willing 
to stay in the study? 
 
During the study, you will be updated about any new information that may affect 
whether you are willing to continue taking part in the study.  If new information is 
learned that may affect you after the study or your follow-up is completed, you will be 
contacted. 
 
Will there be any cost to me to take Part in this study? 
 
There will be no cost to you to take part in the study.  
 
Will I be paid to take part in this study? 
 
You will be paid up to $750.00 for taking part in this study.  
• $100.00 for your baseline assessment (questionnaires + ECG/ICG) 
• $100.00 for end-of-treatment at Week 6 (questionnaires + ECG/ICG) 
• $100.00 for Follow-up visit at Week 12 (questionnaires + ECG/ICG)  
• $ 50 for follow-up visit at Week 18 (questionnaires only) 

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• $ 50 for follow-up visit at Week 24 (questionnaires only) 
• $100.00 bonus for completing all assessment visits 
• $10.00 per week for every week of 6 or more days of valid wear time (i.e., 10 
hours/day for up to 25 weeks) 
 
How will information about me be kept private or confidential? 
 
All efforts will be made to keep your personal information in your research record 
confidential, but total confidentiality cannot be guaranteed. Data will be de-identified and 
coded with an arbitrary ID number. A single, locked document will link participant names 
and ID numbers. Data with identifying information (i.e. consent forms, contact 
information) will be kept separate from coded de-identified data. Any collected data will 
be saved on a private, password protected computer accessible only by the study team. 
Any paper data will be stored in a locked filing cabinet. Audio recordings will not include 
your name and will be kept in a locked filing cabinet. Once data is analyzed from these 
recordings, they will be destroyed. Activity watch data will be downloaded to a secure 
software program and identified with your participant ID only. Any data accessed from 
your medical records will be identified with your participant ID only. Your actual medical 
records will remain at the clinic in their secure database. 
 
The research team may use or share your information collected or created for this study 
with the following people and institutions: 
• Rutgers University investigators involved in this study 
• The Rutgers University Institutional Review Board and Compliance Boards 
• The Office for Human Research Protections in the U.S. Dept. of Health and Human 
Services 
• The National Institutes of Health 
• Fitbit (https://www.fitbit.com/global/us/legal/privacy-summary#info-we-collect) 
• Academic journals that require de-identified data be submitted along with the 
manuscript submitted for consideration for publication in that journal.  
Those persons or organizations that receive your information may not be required by 
Federal privacy laws to protect it and may share your information with others without your 
permission, if permitted by the laws governing them. 
 
A description of this clinical trial will be available on ClinicalTrials.gov, as required by 
U.S. law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this website at any time. 
 
This study is protected by a Certificate of Confidentiality (CoC) from the National 
Institutes of Health. This means that the researchers cannot release or use information, 
documents, or samples that may identify you in any action or suit unless you say it is 
okay. They also cannot provide them as evidence unless you have agreed.  This 
protection includes federal, state, or local civil, criminal, administrative, legislative, or 
other proceedings. An example would be a court subpoena. 
  

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There are some important things that you need to know. The Certificate DOES NOT 
stop reporting that federal, state, or local laws require, such as laws that require 
reporting of child or elder abuse, some communicable diseases, and threats to harm 
yourself or others.  The Certificate CANNOT BE USED to stop a sponsoring United 
States federal or state government agency from checking records or evaluating 
programs. The Certificate also DOES NOT prevent your information from being used for 
other research if allowed by federal regulations. 
  
Researchers may release information about you when you say it is okay. For example, 
you may give them permission to release information to insurers, medical providers or 
any other persons not connected with the research.  The Certificate of Confidentiality 
does not stop you from willingly releasing information about your involvement in this 
research. It also does not prevent you from having access to your own information. 
 
What will happen to my information—data, recordings and/or images—collected 
for this research after the study is over?  
 
After information that could identify you has been removed, de-identified information 
collected for this research may be used for other research we conduct without obtaining 
additional informed consent from you. 
 
What will happen if I do not wish to take part in the study or if I later decide not to 
stay in the study? 
 
It is your choice whether to take part in the research. You may choose to take part, not 
to take part or you may change your mind and withdraw from the study at any time. If 
you do not want to enter the study or decide to stop taking part, your relationship with 
the study staff or the RWJ Cardiac Rehabilitation Program will not change, and you may 
do so without penalty and without loss of benefits to which you are otherwise entitled 
 
You may also withdraw your consent for the use of data already collected about you. If 
you take away permission, your information will no longer be used or shared in the 
study, but we will not be able to take back information that has already been used or 
shared with others. If you say yes now but change your mind later for use of your 
information in the research, you must write to the study director and tell her of your 
decision: 
 
Samantha Farris, Ph.D.  
Rutgers Emotion, Health and Behavior Laboratory 
Department of Psychology  
Rutgers, the State University of New Jersey  
1 Spring Street, Suite 200 New Brunswick, NJ 08901 
 
Who can I contact if I have questions? 
 
If you have questions, concerns, or complaints about the research, wish more 

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information or if you feel you may have suffered a research related injury, you can 
contact the Principal Investigator:  
 
Samantha Farris, Ph.D.  
Telephone: 848-445-2174  
Email samantha.farris@rutgers.edu 
 
If you have questions about your rights as a research subject, you can call the IRB 
Director at:  
 
New Brunswick/Piscataway Art & Sciences Institutional Review Board 
Rutgers, the State University of New Jersey 
335 George Street, Suite 3200 New Brunswick, NJ 08901-8559  
Telephone: 732-235-9806  
Email: humansubjects@orsp.rutgers.edu  
 
Or you can contact the Rutgers Human Subjects Protection Program at (732) 235-8578 
in New Brunswick, email them at human-subjects@research.rutgers.edu., or write them 
at 335 George Street, Liberty Plaza Suite 3200, New Brunswick, NJ 08901. 
 
PERMISSION (AUTHORIZATION) TO USE OR SHARE HEALTH 
INFORMATION THAT IDENTIFIES YOU FOR A RESEARCH STUDY 
 
The next few paragraphs tell you about how investigators want to use and share 
identifiable health information from your medical record in this research. Your 
information will only be used as described here or as allowed or required by law. If you 
sign this consent form, you agree to let the investigators use your identifiable health 
information in the research and share it with others as described below. Ask questions if 
there is something you do not understand. 
 
What Is The Purpose Of The Research And How Will My Information Be Used? 
You are being invited to take part in this research study which is described at the 
beginning of this form. The purpose of collecting and using your health information for 
this study is to help investigators answer the questions that are being asked in the 
research. 
 
What Information About Me Will Be Used?  
 
• 
Assessments, questionnaires, and tasks you complete  
• 
Audio recordings from intervention sessions  
• 
Activity watch for physical activity data 
• 
Information from medical records  
 
Who May Use, Share or Receive My Information? 
 
The research team may use or share your information collected or created for this study 

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with the following people and institutions: 
• Rutgers University Investigators Involved in the Study 
• The Rutgers University Institutional Review Board and Compliance Boards 
• The Office for Human Research Protections in the U.S. Dept. of Health and Human 
Services 
• The National Institutes of Health  
 
Those persons or organizations that receive your information may not be required by 
Federal privacy laws to protect it and may share your information with others without 
your permission, if permitted by the laws governing them.   
 
Will I Be Able To Review My Research Record While The Research Is Ongoing? 
 
No. We are not able to share information in the research records with you until the study 
is over. To ask for this information, please contact the Principal Investigator, the person 
in charge of this research study.   
 
Do I Have To Give My Permission? 
 
No. You do not have to permit use of your information. But, if you do not give 
permission, you cannot take part in this study. (Saying no does not stop you from 
getting medical care or other benefits you are eligible for outside of this study.)  
 
 
If I Say Yes Now, Can I Change My Mind And Take Away My Permission Later? 
 
Yes. You may change your mind and not allow the continued use of your information 
(and to stop taking part in the study) at any time. If you take away permission, your 
information will no longer be used or shared in the study, but we will not be able to take 
back information that has already been used or shared with others. If you say yes now 
but change your mind later for use of your information in the research, you must write to 
the researcher and tell him or her of your decision:  
 
Samantha Farris, Ph.D.  
Rutgers Emotion, Health and Behavior Laboratory 
Department of Psychology  
Rutgers, the State University of New Jersey  
1 Spring Street, Suite 200 New Brunswick, NJ 08901 
 
How Long Will My Permission Last? 
 
There is no set date when your permission will end. The information you provide in this 
study may be used in research for many years. 
 
 

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AGREEMENT TO TAKE PART IN RESEARCH 
 
Subject Consent: 
 
I have read this entire consent form, or it has been read to me, and I believe that I 
understand what has been discussed.  All of my questions about this form and this 
study have been answered.  I agree to take part in this study. 
 
Subject Name (Print): 
 
 
 
 
 
 
 
 
 
Subject Signature: 
 
 
 
 
 Date: 
 
 
 
 
Signature of Investigator/Individual Obtaining Consent: 
 
To the best of my ability, I have explained and discussed all the important details 
about the study including all of the information contained in this consent form.   
 
Investigator/Person Obtaining Consent (Print): 
 
 
 
 
 
 
 
Signature:  
 
 
 
 Date: 
 
 
 
 
 
 
 
 

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ADDENDUM: CONSENT TO AUDIO-/VISUALLY  
RECORD OR PHOTOGRAPH SUBJECTS  
 
You have already agreed to take part in a research study entitled Behavioral Factors 
Influencing Treatment Outcomes in Cardiac Rehabilitation (BE-FIT) conducted by Dr. 
Samantha Farris. We are asking your consent to allow us to audiotape intervention 
sessions with research staff you as part of the research.  You do not have to consent to 
be audio recorded in order to take part in the main research.  
 
The audio recordings will be used for: 
• Analyzing effectiveness of the intervention 
• Analyzing comprehension of use of intervention tools  
• Analyzing comprehension of intervention goals and methods 
• Supervising research staff delivering the treatment sessions 
 
The recording will include your assigned arbitrary ID number. You will not be identified 
by name on the audio recording. We are not videotaping so no identifying features will 
be recorded. The recordings will be stored in a locked filing cabinet with no personal 
identifiers at RWJ Fitness & Wellness or the Rutgers Emotion, Health and Behavior 
(REHAB) Laboratory overseen by Dr. Farris, until such time that a member of research 
staff extracts data from them and enters information into a secure computer platform 
that is password protected. Recordings will be destroyed upon completion of data entry.  
           
Your signature on this form grants Dr. Farris and clinical staff permission to record you as 
described above during participation in the above-referenced study. The investigator will 
not use the recording(s) for any other reason than that/those stated in the consent form 
without your written permission. The audio recordings will not be used by us or distributed 
to investigators for other research after the study is over.  
 
 
 

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AGREEMENT TO BE RECORDED 
 
 
 
Subject Name (Print):______________________________________________________________  
 
Subject Signature ________________________________   Date ______________________ 
 
Investigator/Person Obtaining Consent Name (Printed):___________________________________ 
 
Signature ________________________________________ Date ______________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix D - MOP Modification Log 
MOP MODIFICATION LOG 
Section 
# 
Version 
# 
Date 
Modified 
Page 
# 
Text 
Location 
Brief Modification Summary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix E - Assessments 
  BL  EOT  F1  F2  F3                     ID: ________________                      Date: 
____/____/_____ 
 
BE-FIT RCT Study Measures 
(1)  Medical History & CR Attendance 
Medical Data Extraction Form 
(2)  Exercise Questionnaires 
Exercise Vital Signs (EVS) 
Exercise Sensations Questionnaire (ESQ) 
Fear of Activity in Patients with Coronary Artery Disease (Fact-CAD) 
Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) 
(3) Psychological Factors 
Montreal Cognitive Assessment (MOCA) 
Cardiac Anxiety Questionnaire (CAQ) 
Safety Behaviors Assessment Form (SBAF) 
Threat Perceptions 
Valuing Questionnaire (VQ) 
Intolerance of Uncertainty Scale Short Form (IUS-12) 
Falls Efficacy Scale-International (Short FES-I) 
Discomfort Intolerance Scale (DIS-R) 
Body Vigilance Scale (BVS) 
Multidimensional Assessment of Interoceptive Awareness (MAIA) 
Anxiety Sensitivity Index (ASI-3) 
General Anxiety Disorder 7-Item Scale (GAD-7) 
Patient Health Questionnaire-9 (PHQ-9) 
 
Measure 
Screen 
BL 
EOT 
F1 
F2 
F3 
method 
MoCA 
 
  
  
  
  
  
Interview 
Medical History 
 
  
  
  
  
  
EHR 
CR Attendance 
 
 
 
 
 
 
EHR 
Exercise Vital Signs 
 
 
 
 
 
 
Self-Report 
ESQ 
 
 
 
 
 
 
Self-Report 
CAQ 
 
 
 
 
 
 
Self-Report 
Fact-CAD 
 
  
  
  
  
  
Self-Report 
PRETIE-Q 
 
 
 
 
 
 
Self-Report 
SBAF (relevant items) 
 
  
  
  
  
  
Self-Report 
Threat Perceptions 
 
 
 
 
 
 
Self-Report 
VQ 
 
  
  
  
  
  
Self-Report 
IUS-12 
 
  
  
  
  
  
Self-Report 
FES-I 
 
 
 
 
 
 
Self-Report 
DIS-R 
 
  
  
  
  
  
Self-Report 
BVS 
 
  
  
  
  
  
Self-Report 
MAIA 
 
 
 
 
 
 
Self-Report 
ASI-3 
 
  
  
  
  
  
Self-Report 
GAD-7 
 
  
  
  
  
  
Self-Report 
PHQ-9 
 
  
  
  
  
  
Self-Report 
HR, BP 
 
 
 
 
 
 
Psychophys 
Steps/Day 
 
continuous 
Fitbit 
MVPA Minutes/Day 
 
continuous 
Fitbit 

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Montreal Cognitive Assessment (MOCA) 
 

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Medical Data Extraction Form 
This form is meant to be used ONLY by the clinical staff at Robert Wood Johnson 
Cardiac Rehabilitation and trained, IRB-approved researchers from the Rutgers 
Emotion Health and Behavior Lab.  Patients must give written consent prior to extraction 
of medical data. 
Date of Birth _______________  
 
Race _______________ 
Height ___________  
 
Ethnicity _______________ 
Weight ___________  
 
Marital Status _____________ 
BMI ________  
 
 
Highest Degree ___________ 
Sex _____________ 
 
Employment ______________
 
 
Insurance:    Medicare     Non-Medicare
 
 
Cardiovascular Tests: 
Blood Pressure ________/________ 
Target Exercise Heart Rate Range_______-________ 
 
 
Cardiac Diagnoses:                    Date of most recent qualifying condition 
______/______/_________  
£ Myocardial infarction  
£ Heart failure 
£ PCI: angioplasty/stenting 
£ Heart valve repair/replacement 
£ Coronary bypass surgery 
£ Stable angina 
£ HOCM (cardiomyopathy) 
£ ICD (implanted cardiac device) 
£ Other _____________________ 
 
Other Medical Conditions:  
£ CAD/PAD/atherosclerosis 
£ Hypertension 
£ Hyperlipidemia 
£ Type II diabetes 
£ Smoker 
£ Arthritis 
£ Back pain, other chronic/inflammatory pain 
£ Cancer  
£ Other _____________________ 

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£ Psychiatric Diagnoses 
£ Psychiatric Diagnoses 
Psychiatric Diagnoses: 
£ GAD 
£ Panic disorder 
£ Social anxiety disorder 
£ Specific phobia 
£ OCD 
£ PTSD 
£ Depressive disorder 
£ Bipolar disorder 
£ Psychotic episode/disorder 
£ Somatic disorder/Illness anxiety 
 
Medications: 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
 
Cardiac Rehabilitation:  
Risk stratification:  High   Medium   Low 
Rehab Start Date:  ________________  BE-FIT Start Date: ________________ 
# of Sessions Attended prior to BE-FIT session 1:  ________________ 
# of Sessions Prescribed:  ________________ 
# of Sessions Attended Total (by end of Rehab program):  ________________ 
 
 
 

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Exercise Vital Signs (EVS) 
 
Moderate Intensity Exercise 
• You can talk, but not sing, while performing the activity.  
• Examples: brisk walking, slow biking, doubles tennis, various forms of 
dance, active home chores and gardening, etc.  
 
Vigorous Intensity Exercise 
• You can no longer talk easily during the activity and are somewhat out of 
breath.  
• Examples: jogging, fast bicycling, singles tennis, aerobic exercise class, 
swimming laps, etc.  
 
 
 
 
 
1. On average, how many days per week do you engage in moderate to 
vigorous physical activity (like a brisk walk; see examples above)? 
_____ days  
 
2. On average, how many minutes (per day) do you engage in physical 
activity at this level?  
_____ minutes  
 
 
 
 
For research staff use only: 
Total minutes per week of physical activity (multiply #1 by #2) _____ minutes 
per week  

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Exercise Sensations Questionnaire (ESQ) 
 
For each statement below, circle the one number that best represents your 
level of concern about each sensation if it happened while you were 
doing aerobic exercise, like fast walking or running.  
 
 
Not 
at All 
A 
Little 
 
Some 
 
Much 
Very 
Much 
1 It would scare me if I had joint pain during exercise. 
0 
1 
2 
3 
4 
2 It would scare me if my muscles were sore during exercise. 
0 
1 
2 
3 
4 
3 I would worry if my lower back hurt during exercise. 
0 
1 
2 
3 
4 
4 It would scare me if I had a heavy feeling in my arms/legs during 
exercise. 
0 
1 
2 
3 
4 
5 It would scare me if I felt tired during exercise. 
0 
1 
2 
3 
4 
6 I would worry if my vision was blurry during exercise. 
0 
1 
2 
3 
4 
7 It would scare me if my body ached during exercise. 
0 
1 
2 
3 
4 
8 I would worry if I had a chest pain during exercise. 
0 
1 
2 
3 
4 
9 It would scare me if I had neck pain during exercise. 
0 
1 
2 
3 
4 
10 It would scare me if I didn’t have much energy during exercise. 
0 
1 
2 
3 
4 
11 It would scare me if I felt tingling or numbness during exercise. 
0 
1 
2 
3 
4 
12 I would worry if I felt dizzy during exercise. 
0 
1 
2 
3 
4 
13 I would worry if my heart was pounding or racing during exercise. 
0 
1 
2 
3 
4 
14 It would scare me if I had difficulty breathing during exercise. 
0 
1 
2 
3 
4 
15 It would scare me if I felt faint during exercise. 
0 
1 
2 
3 
4 
16 I would worry if my head was pounding during exercise. 
0 
1 
2 
3 
4 
17 I would worry if I felt tightness in my chest during exercise. 
0 
1 
2 
3 
4 
18 It would scare me if my muscles felt tense during exercise. 
0 
1 
2 
3 
4 
 
 
 

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CAQ 
Please rate each item by choosing the answer (number) that best applies to you. 
Never Rarely Some- 
times Often Alway
s 
1. I pay attention to my heartbeat. 
0 
1 
2 
3 
4 
2. I avoid physical exertion. 
0 
1 
2 
3 
4 
3. My racing heart wakes me up at night. 
0 
1 
2 
3 
4 
4. Chest pain/discomfort wakes me up at night. 
0 
1 
2 
3 
4 
5. I take it easy as much as possible. 
0 
1 
2 
3 
4 
6. I check my pulse. 
0 
1 
2 
3 
4 
7. I avoid exercise or other physical work. 
0 
1 
2 
3 
4 
8. I can feel my heart in my chest. 
0 
1 
2 
3 
4 
9. I avoid activities that make my heart beat faster. 
0 
1 
2 
3 
4 
10. If tests come out normal, I still worry about my heart. 0 
1 
2 
3 
4 
11. I feel safe being around a hospital, physician, or 
medical facility. 
0 
1 
2 
3 
4 
12. I avoid activities that make me sweat. 
0 
1 
2 
3 
4 
13. I worry that doctors do not believe my symptoms are 
real. 
0 
1 
2 
3 
4 
When I have chest discomfort or when my heart is 
beating fast: 
Never Rarely 
Some- 
times Often 
Alway
s 
     14. I worry that I may have a heart attack. 
0 
1 
2 
3 
4 
     15. I have difficulty concentrating on anything else. 
0 
1 
2 
3 
4 
     16. I get frightened. 
0 
1 
2 
3 
4 
     17. I like to be checked out by a doctor. 
0 
1 
2 
3 
4 
     18. I tell my family or friends. 
0 
1 
2 
3 
4 
 
 
 

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FAct-CAD 
The aim of this scale is to evaluate whether there is fear of activity related to your 
heart disease. Please answer all the questions regarding your heart disease. 
Never Seldom Some- 
times Mostly Always 
1.   I can walk on level road as long as I want to despite my 
heart problem. 
0 
1 
2 
3 
4 
2.   I am afraid of any physical activity since I learned of my 
heart problem. 
0 
1 
2 
3 
4 
3.   I feel uneasy when I walk uphill due to my heart 
problem. 
0 
1 
2 
3 
4 
4.   My body doesn’t allow me to do certain activities even 
though I would like to. 
0 
1 
2 
3 
4 
5.   Morning exercises relax me. 
0 
1 
2 
3 
4 
6.   I have difficulty in performing my duties at home due to 
my heart problem. 
0 
1 
2 
3 
4 
7.   I feel chest discomfort if I exert myself a little. 
0 
1 
2 
3 
4 
8.   I cannot carry loads heavier than six pounds after my 
heart problem. 
0 
1 
2 
3 
4 
9.   I do the shopping for my home despite my heart 
problem. 
0 
1 
2 
3 
4 
10. It is not possible to maintain my usual physical activities 
after learning about my heart problem. 
0 
1 
2 
3 
4 
11. I now try to protect myself from strenuous activities. 
0 
1 
2 
3 
4 
12. I feel physically insufficient. 
0 
1 
2 
3 
4 
13. My sexual life is as it used to be. 
0 
1 
2 
3 
4 
14. I refrain from staying alone due to my heart problem. 
0 
1 
2 
3 
4 
15. I am worried that I may hurt my heart/incision if I 
exercise. 
0 
1 
2 
3 
4 
16. I feel demoralized to see that my spouse/relatives are 
more protective of me. 
0 
1 
2 
3 
4 
17. I will exercise if my doctors say so. 
0 
1 
2 
3 
4 
18. It is natural that I am unable to do certain activities that I 
used to do. 
0 
1 
2 
3 
4 
19. My heart problem may get worse if I stay inactive. 
0 
1 
2 
3 
4 
20. I am worried that I will not be able to be as strong as I 
was after my heart problem. 
0 
1 
2 
3 
4 
21. Being physically active makes me feel good. 
0 
1 
2 
3 
4 

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PRETIE-Q 
Please, read each of the following statements and then use the 
response scale on the right to indicate whether you agree or 
disagree with it. There are no right or wrong answers. Work 
quickly and mark the answer that best describes what you 
believe and how you feel. Make sure that you respond to all the 
questions.  
 
1 Feeling tired during exercise is my signal to slow down or stop.  0 1 2 3 4 
2 I would rather work out at low intensity levels for a long duration 
rather than at high-intensity levels for a short duration.  
0 1 2 3 4 
3 During exercise, if my muscles begin to burn excessively or if I 
find myself breathing very hard, it is time for me to ease off.  
0 1 2 3 4 
4 I'd rather go slow during my workout, even if that means taking 
more time.  
0 1 2 3 4 
5 While exercising, I try to keep going even after I feel exhausted.  0 1 2 3 4 
6 I would rather have a short, intense workout than a long, low 
intensity workout.  
0 1 2 3 4 
7 I block out the feeling of fatigue when exercising.  
0 1 2 3 4 
8 When I exercise, I usually prefer a slow, steady pace.  
0 1 2 3 4 
9 I'd rather slow down or stop when a workout starts to get too 
tough.  
0 1 2 3 4 
10  Exercising at a low intensity does not appeal to me at all.  
0 1 2 3 4 
11  Fatigue is the last thing that affects when I stop a workout; I 
have a goal and stop only when I reach it.  
0 1 2 3 4 
12  While exercising, I prefer activities that are slow-paced and do 
not require much exertion.  
0 1 2 3 4 
13  When my muscles start burning during exercise, I usually ease 
off some.  
0 1 2 3 4 
14  The faster and harder the workout, the more pleasant I feel.  
0 1 2 3 4 
15 I always push through muscle soreness and fatigue when 
working out. 
0 1 2 3 4 
16 Low-intensity exercise is boring. 
0 1 2 3 4 
 
I totally disagree 
I disagree 
Neither agree nor disagree 
I agree 
I totally disagree 

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SBAF 
Below is a list of behaviors that people sometimes use to make themselves 
feel more comfortable. For each behavior, please pick the response that 
most accurately describes how often you engage in that behavior. 
 
Never 
Some-
times 
Often 
Always 
1. Stay within certain distances from home (or other safe places) 
0 
1 
2 
3 
2. Call doctors’ offices (or health-lines) frequently 
0 
1 
2 
3 
3. Take it easy when I exercise (or do other activities that require 
physical exertion) so my heart rate does not get too high 
0 
1 
2 
3 
4. Check my body for problems (pain, discomfort, symmetry, 
discoloration, new growth, etc.) 
0 
1 
2 
3 
5. Carry medication in case I need it 
0 
1 
2 
3 
6. Research medical symptoms on the internet 
0 
1 
2 
3 
7. Check my body temperature 
0 
1 
2 
3 
8. Ask others for reassurance (e.g., about a decision or worry) 
0 
1 
2 
3 
9. Check my pulse or heart rate 
0 
1 
2 
3 
10. Talk to others about my health or health-related activities 
0 
1 
2 
3 
11. Pay attention to body for physical symptoms or sensations 
0 
1 
2 
3 
12. Check that I can swallow without choking 
0 
1 
2 
3 
13. Request specialized medical exams from providers 
0 
1 
2 
3 
 
 
 

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Threat Perceptions 
Below is a list of feelings and thoughts that people sometimes have in 
response to engaging in physical activity. We are interested in 
understanding how you feel when you have the most symptoms during 
exercise or physical activity (e.g., heavy breathing, sweating, increased 
heart rate). Please read the list below and indicate to what extent you 
agree with the following statements. 
 
Not at 
all 
A little  
bit 
Moderately Extremely 
1. I feel vulnerable. 
0 
1 
2 
3 
2. I am worried that I am not in control. 
0 
1 
2 
3 
3. I am worried that my symptoms are severe. 
0 
1 
2 
3 
4. I feel helpless. 
0 
1 
2 
3 
5. I am worried that I am going to die. 
0 
1 
2 
3 
6. I am afraid. 
0 
1 
2 
3 
7. I think this event will have a big impact on my 
life. 
0 
1 
2 
3 
 
 
 

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VQ 
Please read each statement carefully and then circle the number which 
best describes how much the statement was true for you DURING THE 
PAST WEEK, INCLUDING TODAY.  
                                                      
Not at  
all true 
 
 
 
  
Completely  
  true 
1. I spent a lot of time thinking about the 
past or future, rather than being engaged 
in activities that mattered to me  
0 
1 
2 
3 
4 
5 
6 
2. I was basically on “auto-pilot” most of the 
time 
0 
1 
2 
3 
4 
5 
6 
3. I worked toward my goals even if I didn’t 
feel motivated to  
0 
1 
2 
3 
4 
5 
6 
4. I was proud about how I lived my life 
0 
1 
2 
3 
4 
5 
6 
5. I made progress in the areas of my life I 
care most about  
0 
1 
2 
3 
4 
5 
6 
6. Difficult thoughts, feelings or memories 
got in the way of what I really wanted to 
do  
0 
1 
2 
3 
4 
5 
6 
7. I continued to get better at being the kind 
of person I want to be   
0 
1 
2 
3 
4 
5 
6 
8. When things didn’t go according to plan, I 
gave up easily   
0 
1 
2 
3 
4 
5 
6 
9. I felt like I had a purpose in life   
0 
1 
2 
3 
4 
5 
6 
10. It seemed like I was just ‘going through 
the motions’, rather than focusing on 
what was important to me 
0 
1 
2 
3 
4 
5 
6 
 
 
 
 
 

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IUS-12 
Please circle the number that corresponds to how much you agree with 
each of the following statements as a general rule. 
Not at all A little  Somewh
at  
Very 
Much  Entirely  
1. Unforeseen events upset me 
greatly. 
0 
1 
2 
3 
4 
2. It frustrates me not having all the 
information I need. 
0 
1 
2 
3 
4 
3. Uncertainty keeps me from living a 
full life. 
0 
1 
2 
3 
4 
4. One should always look ahead so 
as to avoid surprises. 
0 
1 
2 
3 
4 
5. A small unforeseen event can spoil 
everything, even with the best of 
planning. 
0 
1 
2 
3 
4 
6. When it’s time to act, uncertainty 
paralyses me. 
0 
1 
2 
3 
4 
7. When I am uncertain I can’t function 
very well. 
0 
1 
2 
3 
4 
8. I always want to know what the 
future has in store for me. 
0 
1 
2 
3 
4 
9. I can’t stand being taken by 
surprise. 
0 
1 
2 
3 
4 
10. The smallest doubt can stop me 
from acting. 
0 
1 
2 
3 
4 
11. I should be able to organize 
everything in advance. 
0 
1 
2 
3 
4 
12. I must get away from all uncertain 
situations. 
0 
1 
2 
3 
4 
 
 
 
 
 

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FES-I (Short) 
Below are some questions about how concerned you are about the 
possibility of falling. Please reply thinking about how you usually do the 
activity. If you currently don’t do the activity (for example, if someone does 
your shopping for you), please answer to show whether you think you 
would be concerned about falling IF you did the activity. For each of the 
following activities, please check the box which is closest to your own 
opinion to show how concerned you are that you might fall if you did this 
activity.  
 
Not at all 
concerned 
Somewhat 
concerned 
Fairly 
concerned 
Very 
concerned 
1 Getting dressed or undressed  
0 
1 
2 
3  
2 Taking a bath or shower  
0 
1 
2 
3  
3 Getting in or out of a chair  
0 
1 
2 
3  
4 Going up or down stairs 
0 
1 
2 
3  
5 Reaching for something above 
your head or on the ground  
0 
1 
2 
3  
6 Walking up or down a slope  
0 
1 
2 
3  
7 
Going out to a social event (for 
example, religious service, 
family gathering or club 
meeting)  
0 
1 
2 
3  
 
 

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DIS-R 
Instructions: Below are statements about how some people feel and 
behave. For each statement below, circle the number which best describes 
the degree to which the statement applies to you. 
 
Not at all 
like me 
Moderately  
like me 
Extremely 
like 
me 
1. When I feel any physical discomfort, I 
am unable to continue with my daily 
activities. 
0 
1 
2 
3 
4 
5 
6 
2. Experiencing any type of physical 
discomfort is almost unbearable. 
0 
1 
2 
3 
4 
5 
6 
3. When I feel physically uncomfortable, 
it’s difficult for me to function. 
0 
1 
2 
3 
4 
5 
6 
4. When I feel physical discomfort, all I can 
think about is how bad I feel. 
0 
1 
2 
3 
4 
5 
6 
5. I can’t handle feeling physical 
discomfort 
0 
1 
2 
3 
4 
5 
6 
6. There is nothing worse than 
experiencing physical discomfort. 
0 
1 
2 
3 
4 
5 
6 
7. When I feel physical discomfort, I can’t 
help but concentrate on how bad it feels. 
0 
1 
2 
3 
4 
5 
6 
8. Feeling physical discomfort scares me. 
0 
1 
2 
3 
4 
5 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BVS 
This scale is designed to index how sensitive you are to internal bodily 
sensations such as heart palpitations or dizziness. Fill it out according to 
how you have felt for the past week.  
1. “I am the kind of person who pays close attention to internal body 
sensations.”  
 
     0        1        2        3        4        5        6        7        8        9        10 
 
        Not at all                                    Somewhat                             Extremely 
 
 
2. “I am very sensitive to changes in my internal body sensations.” 
 
     0        1        2        3        4        5        6        7        8        9        10 
 
        Not at all                                    Somewhat                             Extremely 
  
 

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MAIA 
Below you will find a list of statements.  Please indicate how often each 
statement applies to you generally in daily life. 
 
Circle one number on each 
line  
Never 
 
 
 
 Always 
1. When I feel physical pain, I become upset.  
0 
1 
2 
3 
4 
5 
2. I start to worry that something is wrong if I 
feel any discomfort.  
0 
1 
2 
3 
4 
5 
3. I can notice an unpleasant body sensation 
without worrying about it.  
0 
1 
2 
3 
4 
5 
4. I can stay calm and not worry when I have 
feelings of discomfort or pain.         
0 
1 
2 
3 
4 
5 
5. When I am in discomfort or pain I can’t get it 
out of my mind. 
0 
1 
2 
3 
4 
5 
6. I listen for information from my body about 
my emotional state.  
0 
1 
2 
3 
4 
5 
7. When I am upset, I take time to explore how 
my body feels.  
0 
1 
2 
3 
4 
5 
8. I listen to my body to inform me about what 
to do.  
0 
1 
2 
3 
4 
5 
9. I am at home in my body.  
0 
1 
2 
3 
4 
5 
10. I feel my body is a safe place.  
0 
1 
2 
3 
4 
5 
11. I trust my body sensations.  
0 
1 
2 
3 
4 
5 
 
 
 

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ASI-3 
Circle the number that best corresponds to how much you agree with each 
item.  
If any items concern something that you have never experienced (e.g., 
fainting in public), answer based on how you think you might feel if you had 
such an experience.  
Otherwise, answer all items based on your own experience. 
Be careful to circle only one number for each item and please answer all 
items.  
 
 
Very 
little 
A 
little Some Much Very 
much 
1. It is important for me not to appear nervous. 
0 
1 
2 
3 
4 
2. When I cannot keep my mind on a task, I 
worry that I might be going crazy. 
0 
1 
2 
3 
4 
3. It scares me when my heart beats rapidly. 
0 
1 
2 
3 
4 
4. When my stomach is upset, I worry that I 
might be seriously ill. 
0 
1 
2 
3 
4 
5. It scares me when I am unable to keep my 
mind on a task. 
0 
1 
2 
3 
4 
6. When I tremble in the presence of others, I 
fear what people might think of me. 
0 
1 
2 
3 
4 
7. When my chest feels tight, I get scared that I 
won’t be able to breathe properly. 
0 
1 
2 
3 
4 
8. When I feel pain in my chest, I worry that I’m 
going to have a heart attack. 
0 
1 
2 
3 
4 

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ASI-3 Continued…  
Very 
little 
A 
little Some Much Very 
much 
9. I worry that other people will notice my 
anxiety. 
0 
1 
2 
3 
4 
10. When I feel “spacey” or spaced out I worry 
that I may be mentally ill. 
0 
1 
2 
3 
4 
11. It scares me when I blush in front of people. 
0 
1 
2 
3 
4 
12. When I notice my heart skipping a beat, I 
worry that there is something seriously 
wrong with me. 
0 
1 
2 
3 
4 
13. When I begin to sweat in a social situation, 
I fear people will think negatively of me. 
0 
1 
2 
3 
4 
14. When my thoughts seem to speed up, I 
worry that I might be going crazy. 
0 
1 
2 
3 
4 
15. When my throat feels tight, I worry that I 
could choke to death. 
0 
1 
2 
3 
4 
16. When I have trouble thinking clearly, I worry 
that there is something wrong with me. 
0 
1 
2 
3 
4 
17. I think it would be horrible for me to faint in 
public. 
0 
1 
2 
3 
4 
18. When my mind goes blank, I worry there is 
something terribly wrong with me. 
0 
1 
2 
3 
4 
 

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GAD-7 
 
Over the last 2 weeks, how often have you been bothered by the following 
problems?   Circle your answer. 
  
 
Not at 
all 
Several 
Days 
More 
than half 
the days 
Nearly 
every 
day 
 1.  Feeling nervous, anxious or on edge 
0 
1 
2 
3 
 2.  Not being able to stop or control worrying 
0 
1 
2 
3 
 3.  Worrying too much about different things 
0 
1 
2 
3 
 4.  Trouble relaxing 
0 
1 
2 
3 
 5.  Being so restless that it is hard to sit still 
0 
1 
2 
3 
 6.  Becoming easily annoyed or irritable 
0 
1 
2 
3 
 7. Feeling afraid as if something awful might 
happen            
0 
1 
2 
3 
  
 
 
 
 
 
 
 
          
               
If you marked any problems on this page, how difficult have these 
problems made it for you to do your work, take care of things at 
home, or get along with other people? Circle your answer below. 
 
Not difficult 
at all 
Somewhat 
difficult  
Very 
difficult 
Extremely 
difficult   
 
 
 
 
 
  
 
 
 

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PHQ-9 
Over the last 2 weeks, how often have you been bothered by the following 
problems?   Circle your answer. 
 
 
Not at 
all 
Several 
Days 
More than 
half the 
days 
Nearly 
every 
day 
 1. Little interest or pleasure in doing things 
0 
1 
2 
3 
 2. Feeling down, depressed, or hopeless 
0 
1 
2 
3 
 3. Trouble falling or staying asleep, or 
sleeping too much 
0 
1 
2 
3 
 4. Feeling tired or having little energy 
0 
1 
2 
3 
 5. Poor appetite or overeating 
0 
1 
2 
3 
 6. Feeling bad about yourself— or that you 
are a failure or have let yourself or your 
family down 
0 
1 
2 
3 
 7. Trouble concentrating on things, such 
as reading the newspaper or watching 
television             
0 
1 
2 
3 
 8. Moving or speaking so slowly that other 
people could have noticed? Or the 
opposite— being so fidgety or restless 
that you have been moving around a lot 
more than usual 
0 
1 
2 
3 
 9. Thoughts that you are better off dead or 
of   
      hurting yourself in some way 
0 
1 
2 
3 
 
If you marked any problems on this page, how difficult have these 
problems made it for you to do your work, take care of things at 
home, or get along with other people? Circle your answer below. 
 
Not difficult 
at all 
Somewhat 
difficult  
Very 
difficult 
Extremely 
difficult   
 

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Appendix F – Adverse Event Form 
 
 
Severity 
Study 
Intervention 
Relationship 
Action Taken 
Regarding Study 
Intervention 
Outcome of AE 
Expected 
Serious 
Adverse 
Event (SAE) 
1 = Mild 
2 = Moderate 
3 = Severe 
0 = Not related 
1 = Unlikely 
related  
2 = Possibly 
related  
3 = Definitely 
related 
0 = None 
1 = Dose modification 
2 = Medical 
Intervention  
3 = Hospitalization 
4 = Intervention 
discontinued 
5 = Other 
1 = Resolved 
2 = Recovered with 
minor sequelae 
3 = Recovered with 
major sequelae 
4 = Ongoing/Continuing 
treatment 
5 = Condition worsening 
6 = Death 
7 = Unknown 
1 = Yes 
2 = No 
1 = Yes 
2 = No 
(if yes, 
complete 
SAE form) 
At end of study only: Check this box if participant had no adverse events 
    None 
 
Adverse Event 
Start 
Date 
Stop 
Date 
Severity Relationship 
Action 
Taken 
Outcome 
of AE 
Expected? 
SAE? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix G – Serious Adverse Event Form 
BE-FIT RCT 
Protocol Number: 
 
Interventionist Name: 
 
Pt ID: 
 
 
Date Participant Reported/Date of Site Awareness: 
            /                   /                        . 
 d d 
m m m 
y y y y 
 
1. SAE Event Term (Diagnosis, ex: Stroke, Myocardial Infarction). 
2. SAE onset date: 
___ ___ / ___ ___ ___ / ___ ___ ___ ___ 
 
d d 
m m m 
y y y 
y 
3. SAE stop date:  
___ ___ / ___ ___ ___ / ___ ___ ___ ___ 
 
d d 
m m m 
y 
y 
y 
y 
4. Location of SAE: 
 
5. Was this an unexpected adverse event? 
 Yes 
 No 
6. Brief description of participant with no personal identifiers: 
Sex:   F 
 M 
Age:  
 
Diagnosis for study participation: 
 
 
 
7. Brief description of the nature of the SAE (attach description if more space is 
needed):  
 
 
 
 
8. Category of the SAE: 
 Date of death___/_____/_______ 
 
 
(dd/mmm/yyyy) 
 Life threatening 
 Hospitalization – initial or prolonged 
 Disability/incapacity 

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 Congenital anomaly/birth defect 
 Required intervention to prevent permanent impairment 
 Other: 
 
9. Intervention type: 
 Medication or nutritional supplement (specify): 
 
 Device (specify): 
 
 Surgery (specify): 
 
 Behavioral/lifestyle (specify): 
 
10. Relationship of event to intervention: 
 Unrelated (clearly not related to the intervention) 
 Possible (may be related to the intervention) 
 Definite (clearly related to the intervention) 
11. Was study intervention discontinued due to event? 
 Yes 
 No 
12. What medications or other steps were taken to treat the SAE? 
 
 
13. List any relevant tests, laboratory data, and history, including preexisting medical 
conditions. 
 
 
14. Was this event a study related endpoint?  
15. Type of report: 
 Initial 
 Follow-up 
 Final 
Signature of principal investigator:  _____________________  Date:  _____________  
 
 
 

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Appendix H - NIA Single-Site Clinical Trial Closeout Procedures  
I. 
INTRODUCTION 
Purpose 
The purpose of this document is to describe an orderly approach to the separation of 
participants from a clinical trial and the administrative procedures associated with the 
trial’s completion. 
Types of Closeout 
A. 
Scheduled - upon completion of the trial. 
B. 
Unscheduled - as a result of failure to obtain continuation funding, 
negative or positive findings, findings in other studies that impact on the 
clinical trial, or other unforeseen events. 
II. 
SITE CLOSEOUT 
The study site is responsible for ensuring the following activities are completed 
prior to study closeout along with the Participant Closeout Procedures described in 
Section III below. 
A. 
Study Forms 
• 
All outstanding forms should be collected, organized, and corrections 
made, where necessary. 
• 
All data queries should be corrected and resolved.  
B. 
Safety Reporting 
• 
All adverse events (both serious and non-serious) should be recorded 
and followed up to resolution in accordance with procedures detailed 
in the protocol. 
• 
All serious adverse events (SAEs) should have been reported to the 
Data and Safety Monitoring Committee (DSMC) or Safety Officer, 
Institute, Institutional Review Board (IRB), and other organizations, as 
specified in the protocol and Data and Safety Monitoring Plan 
(DSMP). 
• 
All adverse events should have been reported as specified in the 
protocol.  
C. 
Study Files 
• 
The investigator’s study files should be complete and up to date with 
originals of the following maintained in the Study Binder, as relevant: 
Ø Investigator(s) Curriculum Vitae(s) (CVs), Licenses and Training 
Records  
Ø IRB approval letters for the protocol, all amendments, Informed 
Consents, annual reviews and advertisements (including updated 
approvals) 
Ø IRB membership list 
Ø All IRB correspondence 
Ø Institute correspondence 

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Ø Site signature log 
Ø Copy of randomization code for randomization, if applicable 
• 
All informed consents should be signed and on file. 
• 
Record retention procedures should be documented with respect to 
type and length of retention and consequences of improper record 
retention and should conform to protocol and institutional 
requirements. The site should be completely familiar with required 
record retention policies. 
D. 
Clinical Supplies 
• 
Clinical supplies, including any treatment intervention materials, must 
be disposed of according to protocol directions. 
E. 
Laboratory Records and Specimen Retention 
• 
The site should ensure that the laboratory records are complete and 
up to date (reference ranges, laboratory certifications, specimen 
tracking records, specimen storage records). 
F. 
Notifications and Equipment Removal 
• 
A final report should be submitted to the IRB and should conform to 
institutional reporting requirements. The report is likely to include, but 
is not limited to, study conduct and outcome, pertinent safety and 
efficacy observations, complete disclosure of any SAEs experienced 
during the course of the study, and the study closeout date. 
• 
As relevant, arrangements should be made for the removal and 
shipment of any study- specific equipment received by the site (e.g., 
computers, diagnostic equipment, and participant monitoring 
devices). 
Figure 1 provides a sample study documentation list, and Figure 2 provides a sample 
Closeout Checklist. 
Study Documentation List 
Document 
Purpose 
Treatment intervention 
product(s) accountability at site 
Documents that the treatment intervention product(s) have 
been used according to the protocol. Documents the final 
accounting of treatment product(s) received at site, dispensed 
to participants, returned by the participants, and returned or 
destroyed. 
Final report by investigator to 
IRB, as required 
 
To document completion of the trial 
Final Trial Closeout 
Monitoring Checklist, if 
relevant 
To document that all activities required for trial closeout are 
completed, and copies of essential documents are held in the 
appropriate files 
Audit Certificate (if relevant) 
To document that audit was performed 
 

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Study Closeout Checklist 
 
  Investigator has signed and dated all forms. 
 
  Forms for all participants have been filed or transmitted as described in the Manual of 
Operating Procedures. 
 
  All appropriate documents are in the study files. 
 
  The final study close-out report has been submitted to the IRB. 
 
  Documents are retained as specified in the Manual of Operating Procedures or IRB 
directives, whichever is longer. 
 
  There is a plan in place in the event of an audit by the NIA, as relevant. 
 
  Final report has been submitted to the NIA. 
 
 
III. 
PARTICIPANT RIGHTS AND NOTIFICATION 
The study site should prepare a letter that thanks each study participant. The letter 
should be circulated to each site for distribution. The letter may include but not be 
limited to the following information: 
• 
Study findings 
• 
Treatment assignment, as relevant 
• 
Treatment options, as relevant, whether continued treatment with the 
assigned intervention is indicated, and how and where treatment may 
be obtained 
• 
Transfer of care responsibilities 
• 
Rights to confidentiality, privacy, and to no further contact from study staff, if 
that is participant’s preference 
• 
Subsequent updates or recalls if new and important information emerges 
following separation 
• 
Contact information of study staff 
A copy of the letter should be included in the participant’s file. 
IV. 
INSTITUTE RESPONSIBILITIES 
The NIA may wish to send staff or a Contractor to ensure that closeout procedures are 
appropriately conducted at any of the study sites.