Feasibility Pilot of Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
Phase: NA
Conditions: PTSD, Cardiac Arrest
Sponsor: Research Foundation for Mental Hygiene, Inc.

Cover Page for ClinicalTrials.govs 
Official Title of the Study: 
Acceptance and Mindfulness Based Exposure Therapy For Survivors Of Sudden Cardiac 
Arrest 
NCT Number:  
 
NCT04596891 
Principal Investigator: 
Yuval Neria, PhD 
Yuval.Neria@nyspi.columbia.edu 
646-774-8041 
Date of Document: 
09/30/2022 
 
 

Statistical Analysis Plan 
 
Study analyses will employ SPSS Statistics version 28.0. This feasibility study was not 
powered to detect treatment effects. Separate repeated measures ANOVAs will be conducted for 
CAPS-5 and HAM-D scores over time will explore treatment effects on psychiatric symptoms.  
For completers, paired sample t-tests will compare symptoms at baseline, posttreatment, and 3-
month follow-up using all available data. Cohen’s d will be computed to determine effect sizes. 
Descriptive statistics will describe the proportion of patients achieving PTSD remission (defined 
a priori as no longer meeting PTSD diagnostic criteria and CAPS-5 score≤23) or clinically 
significant response (≥30% reduction from pretreatment CAPS-5). To classify HamD-17 
depression severity, we will follow recommendations of Zimmerman et al.: not depressed (0–7), 
mild (8–16), moderate (17–23), and severe depression (≥24). 
The first recorded 7200 minutes of Fitbit actigraphy use (confirmed by pulse recording) 
post account activation will define the baseline and will be compared to final treatment week in 
separate paired samples t-tests for average daily steps, sedentary minutes, and minutes asleep. 
Analyses will exclude patients lacking 7200 minutes of final week active wear. 
 

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1
Protocol Title:
ACCEPTANCE AND MINDFULNESS BASED 
EXPOSURE THERAPY FOR SURVIVORS OF 
SUDDEN CARDIAC ARREST
Protocol Number:
8017
First Approval:
09/04/2020
Expiration Date:
07/19/2023
Version Date:
09/30/2022
Research Area:  
Anxiety, Mood, Eating & Related Disorders
Division:  
Anxiety/PTSD/OCD
Contact Principal Investigator:
Yuval Neria, PHD
Email: ny126@columbia.edu
Telephone: 646-774-8092
Co-Investigator(s):
John Markowitz, MD
Maja Bergman
Doron Amsalem
Research Chief:
Helen Simpson, MD
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Anxiety Disorders Clinic
Within the department, what Center or group are you affiliated with, if any? 
PTSD Team
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
PTSD Team
Amendment
Describe the change(s) being made 
Clarifying language has been added to the Methods to Protect Confidentiality to explain that identifiable 

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2
data will be kept on secure, password-protected NYSPI, while some completely deidentified data may be 
stored on secure, password-protected CUIMC servers.
Provide the rationale for the change(s) 
This will allow our collaborators at the Roybal Center for Fearless Behavioral Change at Columbia 
University, the study sponsor, to assist with data analysis.
Comment on the extent to which the proposed change(s) alter or affect risks/benefits to subjects 
N/A
Comment on if the proposed change(s) require a modification to the Consent Form (CF)
N/A
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Audio or Videotaping
   Internet-based Data Collection or Transmission
   Psychotherapy Trial
Population
Indicate which of the following populations will be included in this research
   Adults
   Adults over 50

 
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Protocol Title:
Version Date:
ACCEPTANCE AND MINDFULNESS
BASED EXPOSURE THERAPY FOR
SURVIVORS OF SUDDEN CARDIAC
ARREST
07/11/2022
Protocol Number:
8017
First Approval:
09/04/2020
Expiration Date:
07/19/2022
Contact Principal Investigator:
Yuval Neria, PHD
Email: ny126@columbia.edu
Telephone: 646-774-8092
Co-Investigator(s):
John Markowitz, MD
Maja Bergman
Doron Amsalem
Research Chief:
Helen Simpson, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Anxiety Disorders Clinic
Within the department, what Center or group are you affiliated with, if any?
PTSD Team
Unaffiliated Personnel
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List investigators, if any, who will be participating in this protocol but are not affiliated with New York
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Ian Kronish, MD, Columbia University
Sachin Agarwal, MD, Columbia University
Donald Edmondson, PhD, Columbia University
Jeff Birk, PhD, Columbia University
Alexandra Sullivan, Columbia University
David Lopez-Veneros, Columbia University
Robin Cumella, Columbia University
Gaspar Cruz, Columbia University
Jennifer Mizhquiri Barbecho, Columbia University
Maria Serafini, Columbia University
Ammie Jurado, Columbia University
Brooke Morgan, Columbia University
Tyla Yurgel, Columbia University
Lee Sung, Columbia University
Cara McMurry, Columbia University
Datla Raju, Columbia University
Kaitlin Shaw, Columbia University
Kristal Quispe, Columbia University
Faith Parsons, Columbia University
Application for Continuation of Research
Status
Current Status of Study:
All research interventions were completed. Only data analysis is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and
procedures.
To date we have enrolled 11 participants (7 female and 4 male). Ten participants completed the intervention,
while 1 participant decided to discontinue study involvement. No serious adverse events have occurred, and
all interventions have been well tolerated. There have not been any study findings, recent literature, or
untoward events in the past year which might affect the analysis of the safety, risks, or benefits of study
participation.
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Funding
Have there been any changes in funding status since the prior approval?
No
Have the principal investigator and other investigators made all required disclosures of financial interest in
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in
the past year which might affect the analysis of the safety, risks or benefits of study participation?
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to
subjects or others at this site which occured in the past year)?
No
Have all study staff with a significant role in the design or implementation of the human subject components
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality?
No
Overall Progress
Approved sample size
14
Total number of participants enrolled to date
11
Number of participants who have completed the study to date
10
Have there been any significant deviations from the anticipated study recruitment, retention or completion
estimates?
No
Comments / additional information
Sample Demographics
Specify population
Survivors of Sudden Cardiac Arrest with PTSD
Total number of participants enrolled from this population to date
11
Gender, Racial and Ethnic Breakdown
Gender:
Female: 7 (64%)
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Male: 4 (36%)
Race:
White: 10 (91%)
Black: 1 (9%)
Native American: 0 (0%)
Asian or Pacific Islander: 0 (0%)
Other: 0 (0%)
Ethnicity:
Of Hispanic or Latinx descent: 0 (0%)
Not of Hispanic of Latinx descent: 11 (100%)
Summary of Current Year's Enrollment and Drop-out
Number of participants who signed consent in the past year
6
Did the investigator withdraw participants from the study?
No
Did participants decide to discontinue study involvement?
No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following
procedures
Audio or Videotaping
Internet-based Data Collection or Transmission
Psychotherapy Trial
Population
Indicate which of the following populations will be included in this research
Adults
Adults over 50
Research Support/Funding
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Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol?
Yes
Select one of the following
The grant/contract application is a pending review or a funding decision
Source of Funding
Other
Sponsor
Roybal Center for Fearless Behavior Change at Columbia University
Select one of the following
Single Site
Business Office
RFMH
Does the grant/contract involve a subcontract?
No
Study Location
Indicate if the research is/will be conducted at any of the following
NYSPI
Other Columbia University Medical Center Facilities
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research
Lay Summary of Proposed Research
This pilot trial seeks to examine feasibility, acceptability, safety, and preliminary efficacy of a new
behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post
traumatic stress disorder (PTSD). While several well-studied, validated treatments for PTSD exist, to date,
there is no evidence-based treatment for PTSD in cardiac arrest survivors. Standard PTSD interventions
targeting fear extinction and threat perception in the context of current safety pose a problem in a population
that is living with an actual ongoing cardiac threat. Thus, we will be developing a de novo protocol for an
Acceptance and Mindfulness-Based Exposure Therapy (AMBET) intervention that targets increased
discriminatory perception through mindful interoceptive attention and adaptive threat responding. To assess
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whether patients' medication adherence and physical activity are improved over the course of treatment,
participants will be provided with a wearable device (Fitbit wristband) to monitor their physical activity.
The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for
survivors of sudden cardiac arrest with elevated PTSD symptoms (2) examine its safety and feasibility in a
small sample of 14 patients (3) investigate acceptability and feasibility of the measurements including a
physical activity monitoring device.
The subject population will consist of cardiac arrest survivors with clinically diagnosed PTSD (n=14;
CAPS-5 ≥ 23). In Phase 1 (interview phase), with the aim to develop a treatment manual, 14 SCA survivors
will be interviewed about their symptoms and evaluated for baseline assessment. In Phase 2 (treatment
phase) the same participants will be treated with eight sessions of AMBET. Participants will be evaluated at
baseline, at treatment mid-point (week 4), and at the end of treatment.
Background, Significance and Rationale
Background, Significance and Rationale
Clinically elevated levels of posttraumatic stress disorder (PTSD) symptoms occur in approximately 1 in 3
cardiac arrest survivors with intact cognitive function, and are associated with increased risk for future
cardiac events and mortality(1),(2). Elevated PTSD symptoms have been associated with low adherence to
physical activity and medication adherence in patients with elevated PTSD symptoms after other types of
cardiovascular events(3),(4),(5), in part because medications and physical activity can serve as traumatic
reminders, and nonadherence to cardioprotective health behaviors may explain the association between
cardiac arrest-induced PTSD and poor prognosis. Given the lack of evidence-based psychological therapies
for cardiac arrest survivors with PTSD, the development and testing of an acceptance and mindfulness-
based exposure therapy (AMBET) protocol may be beneficial to survivors of cardiac arrest. Our long-term
goal is to determine the effectiveness of this therapy on reducing psychological distress, reducing aversive
associations with secondary prevention behaviors, and improving quality of life and cardiovascular
outcomes.
Rationale for Intervention: Survivors of acute cardiovascular events (e.g., cardiac arrest, acute coronary
syndrome) are typically encouraged to monitor for somatic cues of cardiovascular activity that might
indicate recurrent events. However, threat-related attention bias is a common sequela of trauma. In cardiac
patients, this hypervigilant attention to interoceptive cues of danger may serve to maintain threat perception,
as arousal amplifies awareness of internal stimuli(6). PTSD symptoms have been associated with attempts
to avoid distressing internal symptoms as well as to negatively influence engagement in health behaviors in
both cardiac and non-cardiac populations(7),(8),(9),(10),(11).
Treatments aimed at reducing fear of interoceptive sensations in patients with various anxiety disorders are,
however, not necessarily applicable to a cardiac population where negative illness appraisals and threat
perception might be realistic. Furthermore, elements of interoceptive exposure frequently utilized in these
treatments such as hyperventilation may not be recommended for some cardiac patients as they may
provoke arrhythmias common among cardiac arrest patients. While no evidence-based treatments for
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cardiac disease induced-PTSD currently exist, initial evidence has been published to suggest the safety, and
potential efficacy of, imaginal exposure in cardiac patients to reduce PTSD symptoms.(12) Among PTSD
treatments, exposure therapy is the most widely recommended. However, even among the most well-
supported treatments for PTSD, the efficacy is moderate, and high dropout rates are well documented(13-
15). The need for novel and adjunctive interventions that will improve treatment engagement and outcomes
has been widely acknowledged(16), (17).
One innovative line of PTSD therapies can be found among mindfulness- and acceptance-based treatments.
Although large scale RCTs are still limited, there are promising findings of treatment effects on reduced
PTSD symptoms, with medium to large effect sizes(18),(19). Reported dropout rates have been low across
treatments, indicating a high degree of treatment acceptability. The addition of mindfulness components to
exposure therapy has been proposed to enhance the effects of exposure as well as the willingness to engage
in them(20). Of particular interest for cardiac patients are findings that mindfulness-based approaches have
normalized cortisol levels and reduced inflammatory biomarkers in PTSD patients, as these are
physiological processes that have been implicated in the links between PTSD and cardiovascular
risk(21),(22),(23). Several mechanisms have been posited to underlie the efficacy of mindfulness-based
approaches including increased metacognitive awareness of interoceptive sensations and mind-body
connections(24),(25). Mindfulness may additionally function as a form of exposure to aversive internal
experiences and reduce distress from attempts to control thoughts and emotions(26), (27), (28).
Furthermore, and contrary to the associations found between hypervigilant interoceptive awareness and
psychopathology, mindful attention to interoceptive cues has been linked with adaptive, resilience-
enhancing behaviors(29).
The goals of the AMBET treatment will be to reduce PSTD symptoms and hypervigilance to internal stimuli
(i.e., interoceptive bias), and increase cardiovascular health behaviors (medication adherence, physical
activity) following cardiac arrest. Following psychoeducation about PTSD and cardiovascular disease
(CVD) related health behaviors, participants will be engaged in in vivo and imaginal exposure exercises to
reduce avoidance responses. Participants will be introduced to acceptance and mindfulness-based strategies
that will be practiced in session and as homework assignments. Sessions will be delivered to patients
individually through HIPAA-compliant zoom-hosted video visits. A meta-analysis of remote (e.g.,
telepsychiatry; video-based) treatments for PTSD found these treatments superior to waitlist conditions.
Compared to face-to-face treatments, videoconferencing CBT treatments did not result in significantly
different PTSD outcomes at post-treatment(30).
Specific Aims and Hypotheses
Specific Aims and Hypotheses
The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for
survivors of sudden cardiac arrest with PTSD; (2) examine its safety and feasibility in a small sample of 14
patients; (3) investigate acceptability and feasibility of the measurements including a physical activity
monitoring device.
Hypothesis 1: The AMBET intervention will demonstrate preliminary tolerability (<20% dropout)
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Hypothesis 2: The AMBET intervention will demonstrate efficacy (pre/post decrements on psychological
distress) and the recruitment goal (n=14) will be met.
Hypothesis 3: Participants will find the health behavior monitoring technology acceptable and comply with
study procedures (wearing Fitbit device daily and during sleep.)
Description of Subject Population
Sample #1
Specify subject population
Survivors of sudden cardiac arrest with clinically diagnosed PTSD (CAPS-5 =23)
Number of completers required to accomplish study aims
10
Projected number of subjects who will be enrolled to obtain required number of completers
14
Age range of subject population
18-85
Gender, Racial and Ethnic Breakdown
Gender:
50% female (N:5-7)
50% male (N:5-7)
Ethnicity:
25% Hispanic
45% White
30% African-American
Description of subject population
All participants will be adult survivors of cardiac arrest who present with clinically elevated PTSD or acute
stress disorder (ASD) symptoms. Patients will be evaluated at the Anxiety Disorders Clinic for potential
inclusion in the study. The expected ethnicity distributions are based on population data from the CANOE
patient registry. The study aims to enroll an equal number of males and females.
Recruitment Procedures
Describe settings where recruitment will occur
Referrals will be done by Dr. Sachin Agarwal's team. Dr. Agarwal is a neurointensivist and founder of the
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Neuro Cardiac Comprehensive Care Clinic (N4C) at New York Presbyterian Hospital/Columbia University
Irving Medical Center (CUIMC). Patients will be recruited from the Cardiac Arrest Neuropsychological
Outcomes Evaluation (CANOE) study (CUIMC IRB- AAAR8497), an observational, prospective cohort
study of cardiac arrest survivors discharged from CUIMC who have consented to being contacted about
future studies. CANOE participants who are currently seen in-person by the CANOE team at the hospital
will be provided with an IRB approved flyer by a CANOE team member informing them of the study and
how to contact the study coordinator. Additionally, the study will be advertised via the Sudden Cardiac
Arrest Foundation’s network, other patient support and interest groups (i.e Facebook groups), and local
cardiology departments informing potential study participants to contact the study team if they are interested
in participation. Posting of the flyer in online support groups will be done by respective group
administrators.
How and by whom will subjects be approached and/or recruited?
Potential patients already enrolled in the CANOE protocol will be asked by Dr. Agarwal's team to contact
the study research assistant who will schedule a phonescreen with the patient. If patient is potentially
eligible, a clinical evaluation will be conducted by the PTSD program clinicians.
How will the study be advertised/publicized?
The study will be advertised via the included recruitment flyer.
Do you have ads/recruitment material requiring review at this time?
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT04596891
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies?
Yes
Describe concurrent research involvement
Subjects will be recruited from CUIMC/CANOE protocol AAAR8497. No identifiable or de-identified data
will be shared back with the CANOE study team.
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Adult survivors of sudden cardiac arrest
Create or insert table to describe the inclusion criteria and methods to ascertain them
Method of
ascertainment
Criteria
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Medical records
demographic
information
1. Males or females between the age of 18-85
2. A PCL-5 score of > 33 at screening and a
CAPS-5 score ≥ 23 at intake assessment
PCL-5, CAPS-5
3. Hospitalization for cardiac arrest with cardiac
etiology at any time in the past.
Medical records review
Create or insert table to describe the exclusion criteria and methods to ascertain them
Exclusion Criteria
Method of ascertainment
Medical records review
1. Heart failure with severe
systolic dysfunction (ejection
fracture < 25%)
Rationale: Patients with severe systolic
dysfunction are unlikely to be able to comply
with study procedures.
Medical records review and/or clinical
interview
Rationale: Patients with terminal non-
cardiovascular illness with life expectancy <1
year are unlikely to be able to comply with
study procedures due to severe limitations.
2. Terminal non-
cardiovascular illness with
life expectancy of <1 year
SCID and clinical evaluation
3. History of psychiatric
diagnosis of psychotic
episode, psychotic disorder,
schizophrenia,
Rationale: Such disorders are considered to
have a more chronic trajectory and there is a
lack of evidence to support the use of
exposure therapy and remote treatments for
this population.
schizoaffective disorder
4. Current severe depression SCID, HAM-D and clinical evaluation.
determined by a) a score of 
Rationale: Patients with severe depression are
>25 on the Hamilton Rating less responsive to exposure therapy and
Scale for Depression (HAM- severely depressed patients may be better
D-17-item), and b) clinical 
served by treatments that target these
assessment
symptoms first.
5. Significant cognitive
impairment
Review of medical records: Cerebral
Performance Category Scale
Defined by Cerebral
MMSE (conducted at intake)
Performance Category Score Rationale: Cognitive impairments at this level
≥3, and/or MMSE score of 
is likely to impact patient ability to complete
<24 neurological impairment study questionnaires and other activities as
precluding ability to
complete study
questionnaires
well as comprehension of study procedures
required for informed consent.
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Clinical interview; score of
> 2 on item 3 of the Hamilton
Rating Scale for Depression
(HAM-D-17-item).
Rationale: To ensure safety of participants,
active suicidal patients will be referred to
psychiatric care.
6. Active suicidal ideation
or behavior
SCID and clinical evaluation.
Rationale: Patients with bipolar illness are less
responsive to exposure therapy and may be
better served by treatments that target these
symptoms first.
7. Current primary diagnosis
of bipolar disorder
8. Current unstable or
untreated medical illness
Clinical evaluation and medical history.
Rationale: Patient safety.
SCID and clinical interview.
9. Current drug or alcohol 
Rationale: Severe substance abuse issues
misuse: severe
alcohol/cannabis or any
should be addressed with evidence-based
treatment targeting these symptoms and
other substance use disorder behaviors that are otherwise likely to interfere
(except nicotine)
with treatment and ability to comply with
study procedures.
10. Recent psychotropic
medication change or
initiation within the last 3
months
Clinical interview regarding current
medication and treatment history.
Rationale: to ensure safety and stability of
management.
11. Initiation of other
psychotherapy within the last
3 months
Clinical interview regarding current
psychotherapeutic treatment history.
12. Patient resides in a state
that does not permit remote
research therapies to be
conducted out-of-state.
Phonescreen
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of
Authorization)
No
Waiver or alteration of consent
No
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Waiver of documentation of consent
No
Waiver of parental consent
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB #
7094R
Describe Study Consent Procedures
Patients will first give verbal consent for the telephone screen with a screener who has at minimum a
bachelor’s degree. Preliminary phone screen will be conducted as approved under Anxiety Disorders Clinic
IRB #7094R. Patients who are found eligible for an intake evaluation will then be emailed a link to a
REDCap e-consent. NYSPI REDCap is a HIPAA approved platform hosted on secure NYSPI servers.
Patients will be informed not to sign the consent until the form is reviewed with a person that is authorized
to discuss and document consent (see section “Persons Designed to Discuss and Document Consent”) and
who has at minimum a master’s degree. After patient reads the consent form the clinician will go over the
form with the patient and answer all the patient’s questions. After answering all the patient’s questions by
the clinician patient will sign the study consent. The signed consent form is available to the study team
immediately upon submission by the participant in REDCap. Throughout this process, the patient will be
told that they are free to refuse to participate in the research and that participation or non-participation in
research has no effect on their ability to continue to receive clinical care or services.
Indicate which of the following are employed as a part of screening or main study consent procedures
Consent Form
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Amsalem, Doron
Bergman, Maja
Campeas, Raphael, MD
Eder-Moreau, Elizabeth
Neria, Yuval, PHD
Sanchez-Lacay, jose, MD
Type in the name(s) not found in the above list
Study Procedures
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Describe the procedures required for this study
As shown in the study overview flow chart below, the study comprises the following procedures: 1)
Eligibility assessment; 2) Baseline assessment with an independent evaluator (IE); 3) Intake interview; 4)
Treatment (during which there will a separate (additional) meeting with the IE at week 4); 3) End of
treatment assessment; 6) Three-month follow-up assessment posttreatment.
The protocol will be carried out remotely. Video-visits and assessments will be conducted over HIPAA-
compliant Zoom (utilizing licensed NYSPI accounts), a password protected and HIPAA compliant
electronic platform. For consent forms and self-report measures, NYSPI REDCap will be utilized to gather
signatures and information from patients. Patients will receive an email with a weblink to complete these on
this HIPAA compliant platform and the data will be stored on secure NYSPI servers.
Approximately 7-10 days after completion of intake interview, participants will receive a package from the
study team that will include the Fitbit required for study participation, along with instructions for how to use
this device. Participants will be provided with a commercially available Fitbit Inspire HR, equipped with a
highly sensitive accelerometer to track activity as well as sleep quantity and sleep quality characteristics
(This product has previously been approved by the CUIMC IRB and used successfully in studies conducted
by Center for Behavioral Cardiovascular Health). The Fitbit will be registered with a study ID and password
and participants will be instructed to download the FitBit app to their phone to sync. Participants will be
asked to continuously wear the Fitbit throughout the study period, including regularly charging the Fitbit
once per week and wearing the device during sleep. The participant will receive push notifications to
recharge the Fitbit if its battery is running low or if the Fitbit disconnects for a prolonged period of time
(>24 hours).
Flow Chart of Study Procedures:
Visit 0: Eligibility Assessment (Review of medical records and phone screening). Potential patients will be
asked by Dr. Agarwal's team to contact the study research assistant who will schedule a phonescreen with
the patient. Alternatively, participants who respond to the flyer may also self-refer to the study by contacting
the research assistant listed on the advertisement. If patient is potentially eligible after completing the
phonescreen, a clinical evaluation will be conducted by the PTSD program clinicians.
Meeting 1: Consent for study participation, baseline assessment, and intake interview. Baseline assessment:
Participants will meet over a HIPAA-compliant zoom video call with a trained research clinician who will
administer the Clinician-Administered PTSD scale (CAPS-5) MMSE and HRSD-17. Participants will also
fill out self-report measures (LEC-5, HADS, CAQ, and MAIA, the Morisky Medication Adherence Scale
[MMAS-8], and four cardiac items from the Anxiety Sensitivity Index [ASI-3]) delivered to them through a
weblink to a REDCap survey. Participants will then meet with the study clinician who will conduct a
qualitative clinical interview (interview guide attached) regarding participant’s experience with PTSD
symptoms reported in CAPS-5.
Following meeting 1, eligible participants will be mailed the study devices and instructions for how to use
them.
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Meeting 2-9
Once weekly AMBET sessions. These visits will last 90 minutes and will be conducted remotely over
HIPAA-compliant zoom video call. Treatment content described below.
Midpoint Assessment: Between treatment session 4 and 5 a visit with an IE will take place over HIPAA-
compliant zoom video call at which participants will complete self-ratings via REDCap survey and the IE
will administer clinical measures (CAPS-5, HamD-17, CGI).
Visit 9: End of treatment arm and posttreatment evaluation. Following the final treatment session,
participants will meet with IE over HIPAA-compliant zoom video call for clinical measures (CAPS-5,
HamD-17, CGI) and given an opportunity to provide feedback on the treatment. Participants will also fill
out self-report measures.
Visit 10: Participants will once again meet with IE at three months posttreatment for forty-five
minutes over HIPAA-compliant zoom video call for a clinical assessment (CAPS-5, HamD-17, CGI).
Participants will also fill out self-report measures (PCL-5, ASI-3, HADS).
Treatment:
Treatment sessions will be carried out virtually over a zoom video call. Treatment sessions will be video
recorded to ensure integrity and treatment fidelity.
Acceptance and Mindfulness Based Exposure Therapy (AMBET)
A manual will be developed to provide clear structure for the course of treatment and will be forwarded to
the IRB when a more complete draft has been finalized. All study therapists conducting the AMBET
sessions will be trained clinicians at master’s or PhD level who have completed training in the protocol and
who have experience delivering exposure therapy to treat traumatic stress. Study therapists will be
supervised by a licensed psychiatrist. The clinician will first provide psychoeducation regarding PTSD
symptoms that can ensue after medical trauma and then introduce the rationale for the treatment. The
principal treatment content can be summarized as: explore personal values and impact of avoidance
behaviors on well-being, increase functional interoceptive awareness and cardiovascular symptom
discrimination through mindfulness and defusion exercises, approach feared events and activities through
values-based exposure, and create meaning and cohesion through flexible perspective taking. The protocol
will primarily target:
1. Maladaptive behavioral responses related to fear (particularly avoidance)
2. Hypervigilant interoceptive attention and catastrophic bias
3. Engagement in heart-healthy behaviors such as physical activity and medical adherence.
The specific interventions are:
A) Mindfulness exercises to increase functional interoceptive awareness and discrimination of
benign/malign symptoms for more accurate threat perception and adaptive responding.
B) Exposure exercises to physical sensations that are similar to cardiac symptoms (e.g., palpitations due to
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physical activity or anxious arousal) to reduce symptom-related hypervigilance and increase adaptive threat
responding. Values exploration to increase motivation for engagement in in-vivo, imaginal, and
interoceptive exposure exercises.
C) Increased physical activity to reduce depressive symptoms and improve cardiovascular health.
Therapist adherence to protocol: All sessions will be videotaped and reviewed for adherence to the
treatment protocol.
You can upload charts or diagrams if any
Criteria for Early Discontinuation
Criteria for Early Discontinuation
Principal Investigator and/or Co-Principal Investigators, will review (at minimum) all currently enrolled
patients in a weekly meeting.
1. Requests to withdraw from the study.
2. Elevated level of distress, for PTSD patients demonstrated by a score of 6 or higher on the weekly CGI
for two consecutive weeks, unless the distress is due to an acute transient event (to be evaluated by treating
clinician, PI, and study psychiatrist). The CGI will be administered to consider both PTSD and Depression
symptomatology.
3. Significant suicidal ideation, as assessed by the study therapist and/or by the HAM-D-Item 3 and/or the
BDI-II suicide item
4. Clear-cut deterioration in social or occupational functioning as assessed by the clinician.
5. Non-compliance with protocol requirements.
6. New or inter-current illness that prevents the patient from complying with the protocol.
In the event discontinuation criteria are met, the treating clinician will meet with the patient to explain the
necessity of termination, provide appropriate referrals, and assist in patient transfer as needed.
Treatment via IRB #8017 will continue until such time as a referral is complete.
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
Treatment credibility will be measured immediately after the first therapy session with the Treatment
Expectancy Questionnaire (TEQ)(31). This measure contains 4 items scored using a 10-point Likert scale (0
“No expectancy/credibility” to 9 “Very strong expectancy/credibility”) concerning how logical the
treatment seems, participant confidence in undergoing the treatment and recommending it to others, and
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their expectations for the treatment’s success. The TEQ has good internal consistency and test-retest
reliability.
Satisfaction with AMBET intervention will be assessed using the Client Satisfaction Questionnaire (CSQ-
3)(32). The CSQ-3 has good test-retest reliability, internal consistency, and sensitivity to treatment.
Fear Related Mechanisms: 1) Interoceptive Attention Style will be measured by the Multidimensional
Assessment of Interoceptive Awareness (MAIA)(33). The MAIA is a self-report measure that assesses
regulatory aspects of interoceptive processing and differentiates between anxiety/hypervigilance driven
interoceptive attention and acceptance/mindfulness-based attention. 2) Cardiac Anxiety will be assessed
using the Cardiac Anxiety Questionnaire (CAQ)(34). The CAQ is an 18-item self-report measure that
assesses heart-focused anxiety across the three subscales fear, avoidance, and attention. 3. Interoceptive
threat bias will be measured using the four selected cardiac-related items from the physical subscale of the
Anxiety Sensitivity Index.(35)
Psychological Distress: 1) PTSD will be measured using the Clinician-Administered PTSD Scale for DSM-
5 (CAPS-5)(36) at intake and post treatment. PCL-5 will be used for screening and prior to weekly sessions
during treatment. 2) Self-reported depression and general anxiety will be measured by Hospital anxiety and
depression scale (HADS)(37) at intake and post-treatment. A clinician will also assess depressive symptoms
using Hamilton Rating Scale for Depression (HRDS-17)(38) at these time points, and Beck Depression
Inventory (BDI-II)(39) will be used as a symptom measure prior to each session.
Health behaviors: Adherence to a representative CVD medication (typically, beta-blocker) will be assessed
using Morisky Medication Adherence Scale (MMAS-8) (40). Physical activity will be measured
continuously for 3-months using a wrist-worn Fitbit Charge accelerometer. The Fitbit device has been
chosen because it has been validated for physical activity and its heart rate monitor performed well against
ECG for heart rate changes at relatively low levels of physical activity (41), (42).
Prior trauma exposure will be measured using the Life Events Checklist (LEC-5)(43).
Clinical severity and change will be measured using the Clinical Global Impression Scale (CGI)(44).
Psychiatric history will be assessed using the Structured Clinical Interview for DSM Disorders (SCID).(45).
Clinician Administered PTSD Scale (CAPS-5) (30 Minutes)
Beck Depression Inventory (10 minutes)
Clinical Global Impression – Severity Scale (CGI-S) (5 minutes)
Clinical Global Impression – Change Scale (CGI-S) (5 minutes)
PTSD Checklist (PCL-5) (5 minutes)
Hamilton Depression Rating Scale (HDRS-17) (10 minutes)
Client Satisfaction Questionnaire (CSQ-3) (2 minutes)
TEQ (2 minutes)
Life Events Checklist (LEC) (5 minutes)
CSQ-3 (5 minutes)
MAIA (5 minutes)
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CAQ (5 minutes)
HADS (5 minutes)
SCID (30 minutes)
MMSE (20 minutes)
MMAS-8 (5-minutes)
ASI-3 (2 minutes)
Please attach copies, unless standard instruments are used
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment
All effort will be made to arrange an intake as soon as possible, within a few days of initial contact if
possible. Clinical staff will meet weekly to discuss new intakes, and disposition to active treatment will be
made as soon as patients have been found eligible and have signed informed written consent. We expect that
patients should enter treatment within two weeks of initial intake date. This allows time to review the
qualitative information from the initial intake interview to develop individualized treatment plans within the
scope of the treatment protocol as well as for delivery of Fitbit device and HIPAA-compliant zoom video
call training. The patient will have immediate access to the intake clinician and study-team psychiatrist if he
or she presents with an emergent clinical issue.
Maximum duration of delay to standard care or treatment of known efficacy
The maximum delay before active treatment of known efficacy is offered will be 12 weeks from baseline
assessment. However, we are not excluding survivors who are currently in other treatment (provided there
has been no change in treatment in previous three months) so for these there will be no delay in treatment.
Treatment to be provided at the end of the study
Participants will be referred for further treatment as needed. The types of referrals offered may include
general referrals to other treatment clinics and centers in the tri-state area, or more specifically referrals may
be offered as preferred to trauma-focused therapists, low-cost therapists and clinics, or to veteran specific
services.
Clinical Treatment Alternatives
Clinical treatment alternatives
Patients who do not participate in research will be referred to treatments for PTSD in the community, such
as cognitive behavioral therapy, prolonged exposure therapy, interpersonal psychotherapy for PTSD, or
psychopharmacology depending on the clinical evaluation and their expressed preferences.
Risks/Discomforts/Inconveniences
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Risks that could be encountered during the study period
Cardiovascular Risk: Physical activity following cardiac arrest is generally recommended and will be
included in the treatment plan only if approval is obtained from the patient’s treating physician. To ensure
patient safety during sessions, participants will be required to confirm the address where they are located at
the start of each remote session as well as to provide the study team with the telephone number to an
emergency contact should any medical emergency occur during the remote procedures. Additionally,
patients will sign a release of information form between the study team and patient’s treating physician. The
study team includes an internist and a neurologist who can both be called upon to determine if urgent
medical attention is needed, and advise for the necessary action (e.g., calling an ambulance). Sessions and
assessments will be scheduled during times when at least one of the study team MD's are available to be
contacted for urgent consultation according to a rolling schedule of on-call responsibilities. Clinicians and
research staff will have a phone available during sessions and patient meetings to be able to call for back-up
while remaining in the HIPAA-compliant zoom session, and the MD can join the zoom call via either
weblink or phone. Before enrolling any patients, all research and clinical team members who do not hold an
MD will receive training in when to contact a study doctor for medical consultations and common
symptoms of cardiovascular events such as stroke or myocardial infarctions warranting immediate 911 call.
This training will be provided by Dr. Ian Kronish over HIPAA-compliant zoom and will be recorded for
asynchronous viewing to ensure all team members are adequately trained.
Psychological Distress: Exposure treatments pose some risk of psychological discomfort. Participants may
find that discussing trauma related memories or facing feared situations may increase emotional distress.
The treatment protocol will start with introduction to grounding techniques such as diaphragmatic breathing
and mindfulness-based techniques for distress management and emotion regulation, and participants will
practice these in session with clinician. Patients will also be informed that they can contact their clinician
between sessions for support and to troubleshoot homework exercises. The treatment will be delivered by a
clinician with experience in treating PTSD with exposure therapy. Additionally, as with any time-limited
treatment, patients may feel uncomfortable when treatment ends. This is an issue that patients will be
encouraged to discuss with their therapist, and treatment will be provided by a clinician experienced in
delivering short-term treatments.
Loss of Confidentiality: A potential risk from this study is the violation of the participant’s privacy, since
patient medical information will be used as a source of data. Special protections against this risk are
provided (see below).
Identification of Severe Mental Illness: There is the possibility that we will discover during screening that
participants have significant cognitive or alcohol/drug impairments that disqualify them from participating
in the study. It may be discovered during screening or during assessment that a participant has severe
depression that warrants immediate treatment. Should the subject express suicidal ideation at any time
during the assessment or treatment, the study clinician will be contacted immediately to assess the subject
and to determine the appropriate course of action.
During intake, treatment and assessment, participants will be required to confirm the address where they are
located at the start of each remote session as well as to provide the study team with the telephone number to
an emergency contact. Participants will be required to provide a response to suicidality item on BDI-II prior
to each session. If a patient would endorse suicidal thoughts, clinician or assessor would further assess risk.
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Clinicians in our clinic are well trained and experienced in conducting suicide assessments and
have additional completed the Comprehensive Suicide Risk Assessment online training course through the
Center for Practice Innovations. Research assistants have access to clinician backup during all scheduled
interactions with research participants and are instructed to immediately contact a clinician if there are
endorsements or disclosures of suicidal ideation for further assessment. In case of active suicidal ideation or
increased risk, clinicians will alert supervising psychiatrist immediately over phone while remaining on
HIPAA-compliant zoom meeting with patient for further action (safety planning and/or contacting
emergency services as appropriate). In cases of acute risk, clinician will call 911 while remaining on
HIPAA-compliant zoom meeting with patient and additionally alert the supervising psychiatrist. Clinician
may contact 911 with or without patient as needed. Patient will be informed of these procedures and
exemptions to confidentiality in such situations during the informed consent procedures. Other options for
addressing suicidal ideation will include safety planning with clinician, 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.
There are no known long-term risks from any study activities.
Interviews/assessments: Some subjects may find the interviews and assessments anxiety provoking or
upsetting. Subjects will be informed that they may choose not to answer specific questions and may stop the
interview at any time if they are feeling uncomfortable. Trained evaluators will be sensitive to patient
vulnerabilities, and every effort will be made to ensure patients’ comfort.
Exposure Therapy: (1) Patients may become distressed by the discussion of sensitive or painful material or
by the experience of strong emotions during treatment. Some patients may find psychotherapy embarrassing
or anxiety-provoking, whether or not the treatment presses them to confront reminders of past traumas. A
risk of this treatment is that it may be ineffective and that patients may not improve or even worsen.
Therapists experienced in treating PTSD patients will assess this distress continually as part of treatment
and will ask for additional evaluations or PI intervention when clinically appropriate. Every effort will be
made to ensure patients’ comfort during treatment, and patients will be withdrawn if needed.
Video recording: Some patients may feel uncomfortable about the treatments being video recorded
(necessary for supervision and treatment integrity checks). However, this will be a required procedure. The
purpose of the videotaping will be explained, confidentiality will be respected, and tapes will be erased after
the spot checks or following supervision. Informed consent for recording will be obtained. Patients will be
informed that they can withdraw their consent at any time, upon which time the recordings will be erased.
Recordings will be made using HIPAA-compliant software through Zoom and stored on password protected
NYSPI servers.
Audio recording: Some patients may feel uncomfortable about the treatment sessions being audio recorded
(necessary for supervision and treatment integrity checks). However, this will be a required procedure. The
purpose of the audiotaping will be explained, confidentiality will be respected, and tapes will be erased after
the spot checks or following supervision. Informed consent for taping will be obtained. Patients will be
informed that they can withdraw their consent at any time, at which point the recordings will be erased.
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Recordings will be made using HIPAA-compliant software through Zoom and stored on password protected
NYSPI servers.
Describe procedures for minimizing risks
Other Procedures for Minimizing Risk:
1) Careful medical and psychiatric screening to identify patients for whom risk for potential adverse effects
are elevated. Such patients will be excluded from the study. As an example, an actively suicidal patient
would be excluded from study participation as per the exclusionary criteria and appropriate clinical
treatment provided.
2) Patients with any of the following will be removed from research and treated openly or as clinically
indicated: a) the occurrence of assaultive or illegal behavior; b) the occurrence of active suicidal ideation at
any point during the trial as assessed by clinical interview; c) behaviors while intoxicated that are a danger
to him/herself or others.
3) Inclusion of psychoeducation about PTSD, the treatment process and memory triggers within the
therapeutic framework and in-session practice of emotion regulation techniques.
4) Careful monitoring of patients during pretreatment and study participation by experienced clinicians.
Patients will see the same clinician for each of their treatment visits.
6) Ability to remove any patient from the study who evidences significant clinical deterioration during
treatment. Provisions will be made for appropriate clinical care of such patients.
7) All data will be coded and stored on secure servers and password protected drives to ensure
confidentiality. All assessment and session procedures will be conducted remotely, using HIPAA compliant
platforms (NYSPI REDCap and licensed Zoom accounts).
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data collected will be kept confidential and used for research purposes only. Patient charts will be kept
on secure and password protected servers. Identifiable data will be limited to secure, password-protected NYSPI 
servers. Some completely deidentified data may be stored on secure, password-protected CUIMC servers. Access 
to research records is restricted to research staff and Federal, State, and Institutional regulatory authorities. No 
subject’s identifying data will be published. All assessment and session procedures will be conducted on HIPAA 
compliant platforms (NYSPI REDCap and licensed Zoom accounts). No data (identifiable or de-identified) will be 
shared with the CANOE study team.
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects
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Direct Benefits to Subjects
This study is not designed to benefit participants directly.
Compensation and/or Reimbursement
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s).
Include justification for compensation amounts and indicate if there are bonus payments.
Participants will be reimbursed for their time participating in the study. Participants will receive $70 for
completing the initial interview and assessment and $50 for completing the midpoint assessment. At the end
of treatment, participants will be paid $50 for completing the post-treatment evaluation and up to $80 for
completing all session survey ($10 for each session survey). Participants will receive an additional $20 for
completing the three-months posttreatment follow-up assessment. Participants will only be compensated for the
tasks and surveys that have been completed. The maximum compensation that can be received for
participation and completion of all study tasks is $270. Pre-loaded PayCards will be delivered individually
within four weeks following each compensation point by mail, in non-identifying manila envelopes.
Participants will be permitted to keep the Fitbit at the end of the study, at which point they can set it up with
their own account.
References
References
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reduction to enhance psychological functioning and improve inflammatory biomarkers in trauma-exposed
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39. Beck, A. T., Steer, R. A., Brown, G. K. (1996). Beck Depression Inventory manual (2nd ed.). San
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Upload copy(ies) of unbolded Consent Form(s)
Upload copy(ies) of bolded Consent Form(s)
Upload copy(ies) of recruitment materials/ads to be reviewed
Upload copy(ies) of the HIPAA form
AMBET_HIPPA_SCAN_090320.pdf
Upload any additional documents that may be related to this study
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Uploads
-HIPAA Form(s)-
AMBET_HIPPA_SCAN_090320.pdf