Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors
Phase: PHASE1
Conditions: Acute Coronary Syndrome, Coronary Artery Disease, Anxiety, Sleep
Sponsor: Massachusetts General Hospital

Remote-delivered Mindfulness-Based Cognitive Therapy to Target Far of Recurrence 
among SCAD Survivors 
 
NCT04983680 
 
May 26th, 2023 

MASS GENERAL BRIGHAM HUMAN RESEARCH OFFICE 
PROTOCOL SUMMARY 
Mass General Brigham Application Form 
 
 
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
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Answer all questions accurately and completely in order to provide the Mass General Brigham IRB 
Office with the relevant information to assess the risk-benefit ratio for the study.  Do not leave 
sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Christina Luberto, PhD 
 
PROTOCOL TITLE 
Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence 
among SCAD Survivors 
 
FUNDING 
NIH 
 
VERSION DATE 
3/09/22 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
The proposed research study has the following objectives:  
 
Specific Aim 1: To explore feasibility and acceptability of UpBeat-MBCT for SCAD survivors 
and make treatment refinements (2 sequential groups of approx. N=8 survivors/group). 
Hypotheses: (1) The intervention will be feasible (enrollment, retention, attendance >70%); and 
(2) acceptable (satisfaction ratings >70%, exit interview themes of satisfaction). 
Specific Aim 2: To explore feasibility of the research procedures (pre-post intervention surveys, 
daily diaries, actigraphy use). Hypothesis: Each research procedure will be feasible (>70% 
completion).  
Specific Aim 3 (exploratory): To explore changes in psychological and behavioral variables 
and their associations. 3a: To explore changes in psychological variables. Hypothesis: 
Participants will report improvements in each UpBeat-MBCT mechanism (non-judgmental body 
awareness, attention regulation, cognitive de-centering, distress tolerance), FOR process 
(interoceptive bias, intolerance of uncertainty), and FOR outcome (FOR severity, cardiac 
anxiety). 3b: To explore changes in behavioral variables. Hypothesis: Participants will report 
improvements in sleep and physical activity outcomes. 3c: To explore associations between 
changes in psychological and behavioral variables. Hypothesis: Changes in psychological 
variables will be correlated with changes in behavioral variables. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Spontaneous coronary artery dissection (SCAD) is an important yet understudied cause 
of acute cardiac events, involving the sudden separation of layers of a coronary artery 
wall, leading to obstructed blood flow. SCAD primarily affects healthy women with no 
cardiovascular risk factors, accounting for up to 40% of cardiac events in young women. 

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The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Given 
the unpredictable onset and disease course, SCAD survivors commonly struggle with 
high fear of recurrence (FOR). Critically, elevated FOR is associated with poor health 
behaviors including poor sleep and physical inactivity, which further increase the risk of 
future cardiac events. A scientific statement from the American Heart Association 
identified a need for interventions to improve outcomes after SCAD, but there have 
been no interventions developed to improve FOR or health behaviors in SCAD 
survivors.  
Mindfulness-Based Cognitive Therapy (MBCT) has the potential to improve FOR and 
health behaviors in SCAD survivors. Evidence supports the efficacy of MBCT to 
improve FOR, sleep outcomes, and physical activity, in other patient populations. MBCT 
is an 8-session group intervention that combines cognitive behavioral therapy with 
mindfulness meditation to teach non-judgmental awareness and self-regulation of 
attention toward the present moment. Our published empirical model explicates how 
MBCT can reduce FOR via increases in four mechanisms of action (non-judgmental 
body awareness, attention regulation, cognitive de-centering, distress tolerance) that 
directly target reductions in two key FOR processes (interoceptive bias, intolerance of 
uncertainty), resulting in improvements in FOR severity and, subsequently, health 
behaviors. 
Through the PI’s current NIH K23 award, our team has already adapted MBCT to target 
the needs of acute cardiac event survivors. The adapted intervention (UpBeat-MBCT), 
was developed through qualitative interviews with 22 cardiac event survivors, primarily 
men who survived acute coronary syndrome (Insight Protocol # 2018P001000). Results 
revealed a multitude of quality of life concerns including FOR, sleep problems, and 
physical inactivity. We adapted MBCT to target these concerns and be appropriate for 
group videoconferencing delivery (Insight Protocol #2020P000045). Given the patient-
informed adaptations and MBCT mechanisms of action, UpBeat-MBCT is hypothesized 
to be feasible, acceptable, and improve FOR and, thereby, health behaviors, for SCAD 
survivors. Given the unique sociodemographic and medical characteristics of SCAD 
survivors, there may be ways to further target UpBeat-MBCT to optimize relevance and 
benefits for this unique population.  
 
This study proposes to adapt the UpBeat-MBCT intervention for SCAD survivors and 
test the feasibility and acceptability of the intervention, delivered via group 
videoconferencing in an open pilot trial. We will explore changes in psychological and 
behavioral variables. This innovative project will the first to explore MBCT for SCAD 
survivors. It will generate knowledge about e-health technologies and congruent 
research methods to apply to other mind-body interventions and patient populations. 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Mass General Brigham researchers.  Provide a brief summary 
of the eligibility criteria (for example, age range, gender, medical condition).  Include any local 
site restrictions, for example, “Enrollment at Mass General Brigham will be limited to adults 
although the sponsor’s protocol is open to both children and adults.”
 
The current study will employ an open pilot trial to determine the initial feasibility and 

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acceptability of a targeted, virtual UpBeat-MBCT intervention for SCAD survivors. We plan to 
enroll approximately N=20 participants (approx. n=8 survivors/group, accounting for 20% 
anticipated lost to follow-up). The UpBeat-MBCT intervention will involve 8 MBCT sessions 
(approximately 1.5 hours each) delivered via synchronous group videoconference, which 
combines cognitive-behavioral therapy, mindfulness meditation, and cardiac health behavior 
promotion. During each session, participants will be taught how to use evidence-based 
mindfulness skills to reduce fear of recurrence and promote positive health behaviors (and 
physical activity). We will hold two intervention cohort groups that will be run sequentially. 
Participants in the intervention will be asked to complete a full survey battery of the measures 
before and after the intervention, and wear an actigraphy device (e.g., to measure physical 
activity and sleep patterns) for 7 consecutive days within the 1-2 weeks before and after the 
intervention. In addition, participants will be asked to complete a daily diary of abbreviated 
measures for 1-2 weeks before and after the intervention. Upon completion of the intervention, 
participants will complete an audio- or video-recorded exit interview (approx. 45-60 minutes).  
 
Inclusion criteria: 
1. Age ≥ 18 
2. Cardiologist-confirmed diagnosis of SCAD in the past 3-18 months 
3. Internet access (via computer or mobile device) 
4. English-speaking and reading 
 
Exclusion criteria: 
1. Terminal illness with life expectancy <1 year 
2. Severe mental illness requiring urgent psychiatric intervention or past-year psychiatric 
hospitalization 
3. Significant cognitive impairment preventing informed consent  
4. Deemed unable to complete research procedures 
5. Unavailable for intervention sessions (e.g., schedule conflicts) 
 
There are no exclusion criteria with respect to ethnicity or socioeconomic status.  
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Mass General Brigham will not participate in the pharmacokinetic portion of the 
study.”  Describe study endpoints.
 
Participant communication: 
Participants will be asked to specify their preferred contact modalities following informed consent. 
Study staff will attempt to engage in contact via phone, paper mail, and/or email to schedule group 
sessions, send study materials and reminders, and send questionnaire batteries and daily diary 
surveys. At minimum, participants will be asked to provide a home address, telephone number, 
and email address to allow for contact and delivery of study materials (e.g., intervention materials, 
actigraphy device, gift cards, etc.). Participants will be made aware of MGB policies regarding 
email per the information below: 
Email: Participants will be given the option to communicate (e.g., receive reminders, schedule, 
etc.) with study staff by email. If the participant chooses email as their preferred method of 
communication, study staff will explain the encrypted, send secure default feature of emails sent 
within the MGB Healthcare network. Patients will receive the following information:  
“The MGB standard is to send email securely. This requires you to initially set up and 
activate an account with a password. You can then use the password to access secure 

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emails sent to you from MGB.  If you prefer, we can send you “unencrypted” email that is 
not secure and could result in the unauthorized use or disclosure of your information. If 
you want to receive communications by unencrypted email despite these risks, MGB will 
not be held responsible. Your preference to receive unencrypted email will apply 
to research studies for emails sent to you from research staff in this study. If you wish to 
communicate with other research staff at MGB regarding additional studies, your 
preference will have to be documented with each research group." 
Adapted MBCT intervention: 
UpBeat-MBCT represents our recent adaptation of the evidence-based MBCT protocol, targeted 
to the needs of acute cardiac event survivors based on the study PI’s K23 qualitative research 
(IRB Protocol Number 2018P001000) and open pilot trial in patients after acute coronary 
syndrome (IRB Protocol Number 2021P000544). It is a virtual 8-week group intervention 
(approx. 90-minute weekly sessions) that combines cognitive-behavioral therapy, mindfulness 
meditation, and cardiac health behavior promotion. There is 15-20 minutes of daily mindfulness 
practice between sessions. Participants are provided an optional home practice record form that 
they can use to keep track of their practice between sessions if they would like. The UpBeat-
MBCT will be tested in the first intervention group, then refined to further target the intervention 
to SCAD survivors, creating SCAD-MBCT for testing in the second group. 
 
Intervention delivery: 
We will deliver the intervention using Zoom or a HIPPA compliant video-conferencing platform 
approved by MGB for use in research virtual visits. Zoom is a secure, HIPPA compliant video-
conferencing software amenable to study procedures, which we have used successfully in prior 
studies to deliver mindfulness interventions to other patient populations (IRB Protocol Number 
2020P000045). Participants will be informed during consent procedures that the 
videoconferencing system uses a secure, HIPPA-compliant software program. We will explain 
that although we will do our best to ensure confidentiality on our end and ask group members to 
not share information outside of the group, we cannot guarantee that other group members will 
not share the content of the group. Participants will be advised to wear headphones and sit in a 
quiet place to protect their own and other group members’ privacy.  
 
Zoom is routinely used at MGB institutions and there is an enterprise license structure and BAA 
that is in place and managed by my team.  There is no end-user license agreement for 
individuals to sign.  Licenses are assigned by my team and users are sent an email with 
instructions/links on how to use the system. Only meeting hosts need to install the app. Zoom is 
a cloud-based solution, so participants need only click on the meeting link in the invitation. 
 
Participants will receive training from study staff prior to the start of the intervention regarding 
the proper use of the video-conferencing software. Study staff will take the necessary steps to 
ensure that the participant is trained in using the videoconferencing software, and the RA will be 
available during intervention sessions to assist with any challenges. We will train participants in 
the videoconferencing program using the training methods ACS patients have asked for and 
which we have used successfully in our prior studies (e.g., instructional handouts, training 
sessions with an RA; IRB Protocol Number 2020P000045). 
 
Intervention fidelity. The intervention will be delivered by the PI, who is a licensed clinical 
psychologist highly trained in the MBCT protocol, and who developed the adapted UpBeat-
MBCT protocol in prior studies. All sessions will be audio-visually recorded using the capabilities 
of the videoconferencing system, after describing this during informed consent and reminding 
the participants that we will do so at the start of the first session. The PI and/or another trained 
study staff clinician will review session recordings and complete a validated MBCT fidelity 
checklist measure (MBCT-AS; included in the IRB submission). We will use the session 

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recordings and fidelity assessment to ensure that the intervention is being delivered as intended 
and are in adherence to the MBCT protocol. Video recording of MBCT sessions is necessary for 
ensuring that the intervention is delivered properly. Intervention fidelity is a critical aspect of 
behavioral intervention research, and video recording of intervention sessions allows for 
assessment of interventionist body language, non-verbal communication, and connection with 
participants, which cannot be obtained from audio alone, and are critical to the delivery of the 
MBCT intervention in particular.  We are using video recording of MBCT sessions in our other 
NIH-funded trials of MBCT (IRB# 2020P000045; 2021P000544). Regarding the exit interview, 
we revised the protocol summary to state that we will only store audio recordings. We will 
conduct the interviews via Zoom but will ask participants to turn their camera off and/or only 
save the audio file of the Zoom recording. 
 
 
Secure storage of recordings. Audio-video files will be labeled with the intervention group 
number, session number, and date. Contact information and personal identifying information 
about the participants will be held in separate, password-protected files on a secure Partner’s 
network. All audio-video files will be stored on a password-protected drive on a secure MGB 
network immediately following each intervention session and will be destroyed 7 years following 
the completion of the study.  
 
Data collection: 
Study assessments include a battery of pre-post self-report surveys administered at baseline 
and post-intervention; post-intervention individual exit interviews (conducted via telephone or 
videoconference), and daily diary surveys and actigraphy assessments (sleep and physical 
activity) collected for 7 days within the 1-2 weeks before and after the intervention. All study 
surveys and daily diaries may be completed via REDCap, email, or paper mail, depending on 
patients’ preferences. Data collection will also consist of viewing and extracting data from the 
EHR of enrolled participants to assess medical and demographic variables (e.g., medical 
diagnoses, medications, cardiac rehab attendance).   
 
Pre-post survey measures: 
The battery of self-report survey measures will be administered within approximately one week 
before and after the intervention. This battery will include the following validated self-report 
surveys: MAIA (body awareness) CAMS-R (attention regulation), EQ (cognitive decentering) 
DTS (distress tolerance), BVS (interoceptive bias), IUS-12 (ability to withstand uncertainty and 
ambiguity of future events), ASC (fear of recurrence), the ASI-3 (cardiac anxiety), the 
Consensus Sleep Diary, the PAVS (physical activity vital sign), Group Cohesiveness Scale, and 
the Program Satisfaction Survey. The baseline survey will also include questions on the 
patients’ sociodemographic characteristics and medical history. Medical characteristics 
including SCAD characteristics (e.g., date, pregnancy associated), prior medical history, 
medical and psychiatric comorbidity, cardiac rehab attendance, and medication will be extracted 
for the participants’ medical records. The pre-post survey battery is included in the IRB 
submission. 
 
Daily Diary: 
Participants will be asked to complete a daily diary of abbreviated survey measures for approx. 
7 consecutive days during the 1-2 weeks before and after the intervention. To reduce survey 
burden, the daily diary will consist of 1-2 items from each of the pre-post survey measures; 
specifically, the items from that had the highest factor loading in the measure’s validation study. 
The evening daily diary will include approx. 10 items. The morning daily diary will include 
approx. 20 items. In addition, to explore the acceptability of the daily diaries, there will be 
approx. 2-3 items asking about the experience of completing the daily diary itself (e.g., ease of 
completion, interference with daily activities). There will be a daily diary assessment each 
evening which includes items for all of the psychological variables and physical activity, and 

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there will be a 1-2 items diary assessing sleep quality each morning. Depending on the 
participant’s preference, daily diaries can be completed via REDCap or emailed forms. The daily 
diary is included in the IRB submission.  
 
Weekly home practice logs:  
Participants will be given optional weekly home practice logs they can use to track their 
mindfulness practices throughout the week if they would like to. As part of the intervention, 
participants will be asked to complete approx. 15-20 minutes of mindfulness practice each day 
in between study sessions. Participants will be provided with optional weekly home practice logs 
they can use to record their experience if they would like to. Participants will not be required to 
submit the log to the study team. Depending on the participant’s preference, home practice logs 
can be completed via REDCap or emailed forms. The home practice log is included in the IRB 
submission. 
 
We will send participants audio recordings via a secure email link or Dropbox, to help with 
completing home practice. 
 
Exit interview: 
Upon completion of the intervention, participants will be asked to complete a 45-60 minute 
individual exit interview via phone or video conference. These interviews will be audio-recorded 
for transcription. The exit interview guide is included in the IRB submission. 
 
Actigraphy: 
An actigraphy device will be used to measure physical activity and sleep patterns. These 
devices are worn on the wrist. Participants will be asked to wear the actigraphy device daily for 
up to approximately 7 consecutive days during the 1-2 weeks before and after the intervention. 
The study team has a set of actigraphy devices which they have pilot tested for participant use in 
prior studies (Dana Farber Harvard Cancer Center IRB Protocol number 20-170). These devices 
will be mailed to participants along with detailed instructions (included in this submission) about 
when and how to wear the devices. Study participants will mail back the devices to the study team 
upon completion of data collection via return-stamped envelopes. Participants who do not mail 
back the devices will be sent a follow-up letter asking them to return the device, along with 
another pre-stamped envelope. All devices will be thoroughly disinfected by study staff between 
usages to prevent the spread of disease.    
 
We will measure the following outcomes using the actigraphy device:  
 
a. Sleep will be measured continuously for 7 days within the 1-2 weeks before and after 
the adapted MBCT intervention using actigraphy (wearable wrist device). We will 
evaluate wear compliance and calculate linear trends in total sleep duration, sleep 
efficiency, wake after sleep onset, and sleep onset latency over the course of the 8-
week intervention (e.g., timings of sleep/awake, timings of being in bed).  
 
b. Physical activity will be measured continuously for 7 days within the 1-2 weeks 
before and after the adapted MBCT intervention using actigraphy (GENEActiv 
wearable wrist device). We will evaluate wear compliance and calculate linear trends 
in moderate-vigorous physical activity, total steps, and sedentary time.  
 
 
Measured Outcomes: 
The primary outcomes are feasibility and acceptability of the intervention and research 
procedures. The exploratory outcomes are changes in psychological and behavioral variables, 
measured via pre-post intervention surveys, and daily diaries and actigraphy each day for 1-2 

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weeks before and after the intervention. Daily diaries will include psychological variables and 
self-reported physical activity (collected at night) and sleep outcomes (collected at morning). 
Covariates will be extracted from the medical record, including date of SCAD event, pregnancy-
associated SCAD, medical and psychiatric comorbidities, cardiac rehab attendance, and 
hospital readmissions. Please refer to tables 1 and 2 below for details of feasibility and 
acceptability outcomes (Table 1) and exploratory outcomes (Table 2).  
Table 1. PRIMARY OUTCOMES (Aims 1 and 2) 
Feasibility  
Enrollment 
>70% of eligible enroll; <20% ineligible due to each criterion; reasons for ineligibility; reasons for 
refusal; characteristics of refusers 
Retention 
<20% participant attrition 
Intervention 
components 
>70% session attendance; fidelity score >70%; <20% of sessions missed due to videoconference 
problems; <20% connections dropped during session; number (M<2.0) and types of 
videoconference problems 
Surveys 
>70% pre-intervention and post-intervention surveys completed; >70% daily diaries completed for 
7 consecutive days; <20% missing data on daily diaries 
Actigraphy 
>70% completed 7 consecutive days 
Acceptability 
Intervention 
components 
Program satisfaction (M>7.0), >70% plan to use the skills, >70% would recommend the program 
to others (post-survey); likes, dislikes, suggestions for program improvement (exit interview) 
Surveys 
Ease of survey completion (1=not at all, 10=extremely M>7.0); level of interference (1=not at all, 
10=extremely M<2.0; post-survey); experiences, challenges, suggestions for improvement (exit 
interview)  
Actigraphy 
Ease of actigraphy completion (1=not at all, 10=extremely M>7.0; post-survey); experiences, 
challenges, suggestions (exit interview) 
 
 
Table 2. EXPLORATORY OUTCOMES (Aim 3) 
Psychological Variables 
Measurement 
 Model Component 
Non-judgmental body awareness 
Multidimensional Assessment of Interoceptive Awareness 
Intervention mechanism 
Attention regulation 
Cognitive Affective Mindfulness Scale-Revised 
Intervention mechanism 
Cognitive de-centering 
Experiences Questionnaire 
Intervention mechanism 
Distress tolerance 
Distress Tolerance Scale 
Intervention mechanism 
Interoceptive bias 
Body Vigilance Scale 
FOR process 
Intolerance of uncertainty 
Intolerance of Uncertainty Scale 
FOR process 
FOR severity 
Assessment of Survivor Concerns 
FOR outcome 
Cardiac anxiety 
Anxiety sensitivity index 3 
FOR outcome 
Group cohesiveness 
Group Cohesiveness Scale 
Moderator 
Program satisfaction 
Program Satisfaction Survey 
Moderator 
Behavioral Variables 
Measurement 
Model Component 
Sleep duration 
Consensus Sleep Diary; Actigraphy 
Health behavior outcome 
Sleep efficiency 
Consensus Sleep Diary; Actigraphy 
Health behavior outcome 
Sleep onset latency 
Consensus Sleep Diary; Actigraphy 
Health behavior outcome 
Moderate-vigorous physical activity 
Physical Activity Vital Sign; Actigraphy 
Health behavior outcome 
Total steps 
Physical Activity Vital Sign; Actigraphy 
Health behavior outcome 
Sedentary time 
Physical Activity Vital Sign; Actigraphy 
Health behavior outcome 
Note. All self-report measures are validated. Variables will be measured pre-post the 8-week intervention, and via daily diaries 
and actigraphy collected each day during the 1-2 week period before and after the intervention.   
 
Analysis Plan 
For Aim 1 and Aim 2 will calculate frequencies and proportions and means and standard 
deviations (or medians and interquartile ranges if variables are non- normal) to assess feasibility 
and acceptability outcomes. T-tests or chi-square will be used to compare eligible patients who 
did and did not enroll, and those who enrolled and dropped out, on demographic and clinical 
variables. Exit interviews will be audio recorded, transcribed, and iteratively analyzed using 

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thematic content analysis in NVivo 11. Transcripts will be reviewed by two members of the study 
team to identify themes and develop a coding framework. Discrepancies in coding will then be 
resolved through discussion.  
For Aim 3, we will examine frequency distributions for each exploratory outcome at each 
timepoint and use non-parametric tests if needed. We plan to use linear mixed effects models 
with repeated measures and an unstructured covariance matrix to assess changes over time for 
each psychological and behavioral variable (separate dependent variables. The predictor 
variables will be time (fixed effect: up to 16 levels across pre-post intervention surveys and daily 
diaries or actigraphy) and covariates relevant for each dependent variable (random effects). If 
there are any time effects, we will conduct follow up analyses to determine if those effects show 
a change over the course of the intervention period in the expected direction. We will create 
change scores (post-intervention survey minus pre-intervention survey) and explore correlations 
of changes in psychological variables with changes in behavioral variables. Missing data will be 
imputed using maximum likelihood estimation and, as a sensitivity analysis, the last observation 
carried forward. Given the exploratory nature of the proposed pilot study, we will focus the 
interpretation of Aim 3 analyses on effect sizes (Cohen’s d) rather than statistical significance to 
assess potential signals for intervention effects. 
For studies involving treatment or diagnosis, provide information about standard of care at Mass 
General Brigham (e.g., BWH, MGH) and indicate how the study procedures differ from standard 
care.  Provide information on available alternative treatments, procedures, or methods of 
diagnosis.
 
All study participants will continue to receive standard care. The study procedures differ from 
standard care in that patients will be approached about the study and invited to participate. 
Those who are eligible and interested in participating will receive training in an evidence-based 
skills building program with their peers and a trained instructor. All patients who choose to 
participate in the study will continue to receive standard care with no other differences in their 
treatment beyond additional training in psychosocial skills. The alternative is to continue 
standard care without also participating in the study intervention.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
To minimize risks, all procedures will be performed in clinically stable participants who meet 
eligibility criteria. Participant risks are mitigated by excluding participants who are particularly 
vulnerable including those with severe mental illness, or those who are cognitively impaired, 
have short life expectancy. Participants will also be told that all participation is voluntary, and 
they can withdraw from the study at any time. Also, they will be told that the care they receive 
from their treating providers will in no way be affected by their participation or decision not to 
participate in this study.  
Any serious adverse events (SAEs) will be reported to the IRB. SAEs will be collected and 
reported from screening to 30 days after the end of the study follow-up period for an individual 
participant. SAEs will be followed until resolution, stabilization, or until it is determined that study 
participation is not the cause. 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.

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As the intervention is psycho-educational in nature, and participants do not need to physically 
come to the hospital to participate in any study procedures, there is no risk of physical injury to 
participants. Participation is voluntary for all subjects. As explicitly stated in the informed 
consent documents, participants may withdraw from participation at any time by notifying study 
staff. Participants will not be required to provide a reason for withdrawal. Participants will be 
reminded that they can withdraw from the study at any point during their participation.  
 
The main safety concern related to patients in this study is worsening psychological symptoms. 
Subject safety regarding psychological symptoms will be ensured per the protocol below.  
 
The study therapist conducting the intervention session will be a trained clinician with a PhD in 
clinical psychology and expertise in the MBCT protocol. Thus, the study therapist will have 
expertise in assessment and treatment of mental health disorders and will be trained to identify 
if participants are experiencing severe psychological distress and can intervene if needed. The 
interventionists will observationally monitor participant’s symptoms during each weekly 
intervention session. If the interventionists become concerned based on a participant’s 
presentation during a session (e.g., per their clinical observation or expressed SI by a 
participant), they will call the participant by phone individually immediately after the session to 
check in about the participant’s symptoms and conduct a safety assessment if needed. The 
interventionists will instruct patients at the start of the first session that if they experience 
worsening mood symptoms or concerns for their safety (e.g., suicidal thoughts) at any point 
during the study, they should let the interventionist, study staff, and/or their doctors know. At the 
start of the first session, we will (a) instruct participants that the group will be discussing 
emotional resiliency after SCAD and not medical details of SCAD, (b) instruct participants not to 
share personal details of their SCAD or relive their SCAD experience within the group, and (c) 
ask participants to share 1 positive coping skill they are using for their emotional well-being. The 
interventionist will interrupt any participants who overshare details of their SCAD and re-direct 
the discussion to positive coping. Participants will be instructed to call or email the research 
assistant (a) if they experience significant distress after the first session, or (b) if they 
experience any difficulties with the intervention throughout the study and would like an individual 
check in with the interventionist. In both cases the interventionist will call the patients for 
assessment and intervention if needed. Should a participant express suicidal ideation at any 
time during the study, the study clinician will immediately assess the subject and determine the 
appropriate course of action. Options for addressing suicidal ideation will include contacting the 
individual’s treatment provider, referring for urgent (same day) evaluation and treatment in an 
outpatient clinic, or emergency room evaluation and hospitalization. Similar practices will be 
used for other emergencies, including but not limited to psychosis, homicidal or violent thoughts, 
or an acute change in a subject’s physical status. The study PI (Dr. Luberto) and two of the 
study Co-Is (Drs. Hall and Park) are both licensed psychologist; Co-I Dr. Wood is a board-
certified cardiologist. All of these members of the study team will be available to discuss and 
respond to concerns of participant safety over the course of the study.  
 
The objective criteria for removal from the study is worsening psychiatric symptoms that 
become psychiatrically unstable that precludes their participation (e.g., constitute danger to self 
or others). The PI will let the participants know that if it seems unsafe for them to remain in the 
study, the PI will contact them. In cases where psychological symptoms are worsening but do 
not constitute necessary removal from the study, the PI will discuss the concerns with the 
participant, give them the option to exit the study if they would like, and assist them in 
connecting to a higher level of care if needed (e.g., by providing mental health referrals).  
To ensure the physical safety of participants, we will inform treating cardiologists that physical 
activity will be tracked as part of the study and obtain approval that it is safe for the participant to 

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be applying intervention skills to increased physical activity. Following guidelines from a 2018 
AHA scientific statement on SCAD, we will advise SCAD patients in the trial to avoid prolonged 
high-intensity activities, highly competitive or contact sports, activities performed to exhaustion, 
abrupt increases in physical activity without warm-up, and exercising in extreme temperature. 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
As in any research study, there is a small risk that confidentiality may be breached; all efforts to 
minimize this risk will be taken, as outlined above. Patients may face discomfort with 
intervention procedures, survey questionnaires, and exit interview topics. All measures to 
maintain participant safety, satisfaction and comfort are detailed above.    
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
While participants in this study may not directly benefit from their participation, we anticipate 
results from this study to benefit future research that seeks to reduce fear and improve health 
behaviors after SCAD. Participants may benefit from receiving the adapted MBCT intervention 
in terms of increase in mindfulness skills to cope with health-related fears, opportunity for peer 
support and clinician attention, and improvement in health behaviors.  
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
All adult subjects who satisfy the inclusion/exclusion criteria are eligible for enrollment in this 
study regardless of sex, race or ethnicity.   
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
11 
Only participants who can read and speak English will be included in the current study, as the 
intervention and most assessment measures have not been validated for use in non-English 
speaking populations. 
 
For guidance, refer to the following Mass General Brigham policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Obtaining%20and%20Doc
umenting%20Informed%20Consent%20of%20Non-English%20Speaking%20Subjects.pdf   
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Patients will be recruited via the MGH SCAD clinic through hospital flyers and cardiologist 
referrals. SCAD clinic cardiologists will obtain verbal permission from patients to share their 
information (e.g., name, phone number, MRN) with the study team. A member of the study team 
will then reach out to the patient to see if they are interested in participation. If the patient is not 
interested in study participation, study staff will discontinue contact. Patients will also be 
recruited through cardiologists’ patient lists. The cardiologist and/or study staff will review the 
patient list for patients who have had SCAD in the past 3-18 months. Study staff will then send 
potentially eligible patients research invitation letters through Patient Gateway. Only patients 
who have agreed to be contacted about research studies will be sent a letter. We will use the 
required Research Invitation template (attached). Patients who proactively opt-out of the study 
will no longer be contacted. Patients recruited through hospital flyers may also contact the study 
team directly via phone or email, following the contact information on the flyer (e.g., study phone 
number and email address). The patient will be asked to provide the name of their cardiologist, 
who the study team will then contact to confirm the patient’s history of SCAD, or the patient will 
be asked to give permission for study staff to review their electronic medical record to confirm a 
SCAD diagnosis.  
 
Patients who are interested in study participation will be screened for eligibility over the phone 
by the study RA, who will be CITI certified and trained in all research procedures. The RA will 
explain the study procedures, answer any questions, and complete an eligibility screening, 
which will include: confirmation of the patient’s age (> 18 years old), SCAD diagnosis in past 3-
18 months, internet access, ability to speak and read English, no terminal illness, no severe 
mental illness or past-year psychiatric hospitalization, no cognitive impairments preventing 
informed consent, ability to complete research procedures, and availability for planned session 
times. Confirmation will be based on the patient’s verbal report, study staff’s clinical judgment, 
and/or the patient’s medical history. The RA will consult with the PI and/or review the patient’s 
electronic medical record to confirm any questions about eligibility. If participants meet study 
criteria, they will complete the informed consent process described below. The eligibility 
screener and phone scripts are included in the IRB submission. 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
12 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Participants will be reimbursed using the Partners Advarra Participant Payments System. 
Advarra Payments is a cloud-based application that provides subjects with a reloadable Visa 
card that is credited with fixed stipends following specified data collection points. Participants 
will be informed of Advarra policy via the informed consent form. After agreeing to participate in 
the study, participants will also be asked to sign a “Advarra Participant Payment Card 
Acknowledgement of Receipt Form” form, to certify their understanding of Forte Payment 
polices. The form will require the subject to print and sign their name and provide their social 
security number. When mailing “Advarra Participant Payment Card Acknowledgement of 
Receipt Form” form is not an option (e.g., due to COVID work restrictions), participants will be 
asked to complete the form electronically via REDCap. Similar to the electronic consent process 
detailed below, study staff will email participants a link to an electronic version of the form. 
Participants will be given time to review Advarra guidelines, and when ready will review and 
electronically sign the “Advarra Participant Payment Card Acknowledgement of Receipt Form” 
form with study staff over the phone. Participants will then be provided with the option of 
receiving a mailed copy of the completed form through send secure email or through paper mail. 
All paper versions of the Advarra acknowledgement forms will be stored in a locked, study 
cabinet.  
 
Participants will be remunerated up to $50 via a reloadable debit card. Participants will receive 
$10 each for completing 80% of actigraphy days, 80% of daily diaries, the baseline survey, the 
post-intervention survey, and the exit interview. 
 
For guidance, refer to the following Mass General Brigham policies: 
          Recruitment of Research Subjects           
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Recruit
ment%20of%20Research%20Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects          
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Guidelin
es%20for%20Advertisements%20for%20Research%20Subjects.pdf 
 
          Remuneration for Research Subjects
          
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Remune
ration%20for%20Research%20Subjects.pdf 
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
13 
A member of the study staff will determine patients’ eligibility status, explain the purpose of the 
study and study procedures, and answer any questions prior to completing informed consent 
per the information below. Patients will be provided with the informed consent document 
electronically or via paper mail. The informed consent document will then be carefully reviewed 
with study staff via discussion with the patient either by phone or videoconference. Additionally, 
to ensure that patients understand what their participation will entail, they will be asked to 
reiterate in their own words the purpose of the research, what they will need to do as 
participants in the study, and what the potential risks, potential benefits, and alternatives are. 
After the form is reviewed by both study staff and the patient and all of the patient’s questions 
have been answered, the patient may then sign and submit the form electronically or via paper 
mail. All patients will be provided with study staff contact information if any questions or 
concerns regarding the research arise.  
As stated above, member of the study staff will obtain informed consent in one of two ways, 
depending on patient preference: 1) electronically (via REDCap or emailed pdf of the consent 
form) or 2) via paper mail correspondence. Patients who opt to receive the consent materials via 
paper mail will be asked to provide a mailing address. Patients who opt for electronic consent 
will be made aware of security concerns related to email communication (as described earlier) 
and, after specifying their preference for encrypted or unencrypted email, be emailed the 
informed consent portal via REDCap or electronic copy of the consent form.   
 
Electronic Informed Consent Process (EIC):  
Patients will be emailed the informed consent portal via REDCap. The REDCap link will connect 
the patient to an encrypted REDCap portal; the Electronic/Paperless Consent (EIC) Template 
Project will be used. Once the patient confirms receipt of the EIC form link, they will be 
prompted to enter in their full name and birthday to access the informed consent form and verify 
their identify. This portal will have the electronic (paperless) consent form, exactly identical in 
content to the paper version, to guide the patient, through the consent discussion with study 
staff over the phone. The patient will be given ample opportunity to ask questions and take their 
time to consider their participation. If a patient would prefer, they may return to the EIC portal as 
many times as they would like to review the consent form on their own time. When ready to sign 
consent, patients will digitally sign and date/time the consent form. Additionally, the patient will 
be prompted after signing to indicate the method through which they would like to receive a 
copy of the consent form for their record: digitally or through hard copy. If a patient would like to 
receive a copy of the consent form digitally, they will be asked of their preference to receive the 
email as encrypted, the default, or opt-out and receive the email unencrypted. These options 
allow participants to be informed of what an encrypted (Send Secure) email would appear as in 
their inbox and the steps to get into the email, or alternatively, to give permission receive the 
email without this extra layer of security but in a more accessible format. MGB language 
concerning the Send Secure feature is included to assist in this decision. Study staff will confirm 
receipt of the digital signature and will sign and date the consent form as the consenting study 
staff member. At any point, if a participant would prefer to receive a hard copy of the consent 
form, the EIC process will stop, and study staff will commence the phone and mail 
correspondence process for informed consent. 
 
Participants may also elect to receive an electronic copy (pdf) of the consent form via email, 
according to the email security procedures previously described. In this case the participant 
could print and sign the form and either scan/email or send via paper mail back to the research 
team.   
 
Paper mail correspondence: 
If the patient would prefer to complete the informed consent process via paper mail, study staff 
will start by facilitating the informed consent discussion over the phone. Once all questions are 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
14 
answered to the satisfaction of the patient, study staff will mail 2 signed copies of the informed 
consent form for the patient to review, sign and mail back one copy at their convenience. 
Participants will be provided with a pre-stamped, pre-addressed envelope for their return. Study 
staff will maintain one copy of the informed consent form for study records, participants will be 
instructed to maintain one copy for personal reference.  
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the Mass General Brigham IRB website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Mass General Brigham policy: 
     Informed Consent of Research Subjects:
  
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Informe
d%20Consent%20of%20Research%20Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
The Study Principal Investigator, Dr. Luberto (licensed clinical psychologist), will be 
responsible for ensuring participants’ safety on a daily basis. She will be assisted in this 
responsibility by Dr. Park (licensed clinical psychologist) and Dr. Wood (board-certified 
cardiologist), and the clinical research coordinator. Together, they will be responsible for 
monitoring participant safety, evaluating the progress of the study, reviewing procedures for 
maintaining the confidentiality of data, the quality of data collection, management, and 
analyses. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Mass General Brigham IRB and, when applicable, for submitting sponsor safety reports 
and DSMB reports to the Mass General Brigham IRBs.  When the investigator is also the 
sponsor of the IND/IDE, include the plan for reporting of adverse events to the FDA and, when 
applicable, to investigators at other sites.   

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
15 
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Mass General Brigham IRB guidelines for Adverse Event Reporting
 
All PHRC guidelines will be followed with respect to reporting unanticipated problems, including 
adverse events. Specifically, when a serious or non-serious adverse event occurs, the PI will 
review the event to determine if it was possibly or definitely related to participation in the 
research. For all unanticipated problems and adverse events deemed related or possibly related 
to the research, a member of the research team will complete and submit an Other Event report 
through Insight/eIRB as soon as possible and within 5 working days / 7 calendar days (as 
defined in the March 2014 Reporting Unanticipated Problems Including Adverse Events report). 
At Continuing Review, a summary of all unanticipated problems will be provided as per PHRC 
protocol. Finally, if there are unanticipated problems, especially if serious or recurrent, the PI will 
amend the protocol if it is deemed necessary to protect the safety and welfare of the 
participants. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
On a weekly basis, the research team will meet to review study progress. At that time, the 
principal investigator will review consent form documents, study forms, and/or research 
procedures completed that week.  The study team will also discuss any procedural difficulties, 
recruitment issues, and adverse events at this meeting (and before if needed). Investigators will 
address acute issues in real time throughout the week as needed. 
 
 
For guidance, refer to the following Mass General Brigham policies: 
          Data and Safety Monitoring Plans and Quality Assurance         
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Data%2
0and%20Safety%20Monitoring%20Plan%20in%20Human%20Subject%20Research.pdf 
 
          Reporting Unanticipated Problems (including Adverse Events)
https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Documents/Reportin
g%20Unanticipated%20Problems%20including%20Adverse%20Events.pdf
 
 
 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
16 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
In terms of risks to privacy, there is an inherent risk in the discussion-based group intervention 
format. There is a risk of a participant sharing personal information gathered from the groups 
with his or her family, friends, co-workers, doctor, etc. To minimize this risk, participants will be 
asked not to share any personal information shared within the group sessions with outside 
sources. During the consent process, participants will be asked to consent to the rules of 
confidentiality and will be informed that the research team cannot 100% guarantee that all 
participants will maintain confidentiality. Participants will also be made aware that confidentiality 
would be broken if an individual seems at risk of harming themselves or others, in order to 
obtain appropriate care for the person. Study staff will monitor the intervention groups to 
determine whether any information raises questions about safety risk.  
 
The PI will oversee all data collection and analysis and will ensure the integrity of the project. As 
noted above, study data will not be linked to any identifying information; rather study ID 
numbers will be assigned and used to identify participants. All study forms and data will be 
stored in an access-restricted database, in which only trained study staff will have access to. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE MASS 
GENERAL BRIGHAM 
Specimens or data collected by Mass General Brigham investigators will be sent to research 
collaborators outside Mass General Brigham, indicate to whom specimens/data will be sent, what 
information will be sent, and whether the specimens/data will contain identifiers that could be 
used by the outside collaborators to link the specimens/data to individual subjects.
Data collected from the current study will not be sent to research collaborators outside of 
Partners. 
 
Specifically address whether specimens/data will be stored at collaborating sites outside Mass 
General Brigham for future use not described in the protocol.  Include whether subjects can 
withdraw their specimens/data, and how they would do so.  When appropriate, submit 
documentation of IRB approval from the recipient institution.
 
Data will not be stored at collaborating sites outside of Partners for future use not described in 
this protocol.  
 
 

Mass General Brigham IRB Application Form 
  
Filename: Protocol Summary 
Version Date:  February, 2021 
 
  
17 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
MASS GENERAL BRIGHAM 
When specimens or data collected by research collaborators outside Mass General Brigham will 
be sent to Mass General Brigham investigators, indicate from where the specimens/data will be 
obtained and whether the specimens/data will contain identifiers that could be used by Mass 
General Brigham investigators to link the specimens/data to individual subjects.  When 
appropriate, submit documentation of IRB approval and a copy of the IRB-approved consent 
form from the institution where the specimens/data were collected.
 
Data will not be collected by research collaborators outside of Partners.