Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
Phase: NA
Conditions: Acute Coronary Syndrome, Fear, Medication Adherence
Sponsor: Columbia University

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Official title of project: INvestigating Fear Of Recurrence as a modifiable Mechanism of 
behavior change to improve medication adherence in acute coronary syndrome patients (the 
INFORM Study) 
 
NCT number of project: NCT03853213 
 
Document date: 06/21/2019 
 
Principal Investigator:  Jeffrey Birk, PhD 
 
 
 
 
 
 
 
 

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1. Study Purpose and Rationale 
 
Acute coronary syndrome (ACS; myocardial infarction or unstable angina) is a leading cause of 
morbidity and mortality in the U.S., and survivors are at high risk for recurrent cardiovascular 
disease (CVD) events, particularly if they do not adhere to risk-reducing medications. Failure to 
take aspirin as prescribed is associated with 75% increased risk of recurrent CVD events or 
mortality,1 and half of ACS patients are nonadherent to secondary risk medications by 1 year 
after the index ACS event. Emerging evidence suggests that posttraumatic stress disorder 
(PTSD) symptoms following ACS and other cardiovascular disease (CVD) are strongly 
associated with medication nonadherence, and ~50% of patients report symptoms.2-4 Indeed, our 
pilot data suggest that those who are most distressed by a CVD event (as evidenced by PTSD 
symptoms) are also those least likely to behave in ways that would reduce the probability of 
CVD event recurrence.5 
 
PTSD caused by a life-threatening medical event is reliably associated with heightened fear of 
CVD event recurrence.6-8 We and others have proposed that ACS-induced PTSD symptoms may 
be distinct from PTSD due to stereotypical traumatic events such as combat or assault, because 
intrusive thoughts may be focused on fear of CVD event recurrence (FoR) in the future, rather 
than preoccupation with the past cardiac event.9 Ironically, rather than promoting preventive 
health behaviors, FoR may be associated with worse medication adherence, as patients who 
develop PTSD symptoms report avoiding medications because they do not want to be reminded 
of their CVD risk.10 It is possible that the small/distal perceived CVD benefit of adherence 
relative to the large/proximal psychological benefit of avoidance10 may result in nonadherence. 
We now propose to determine whether FoR is a modifiable mechanism linking PTSD symptoms 
with nonadherence to aspirin for secondary prevention in ACS patients.  
 
We will use the Science of Behavior Change (SOBC) experimental medicine approach to 
identify, measure, and influence FoR and related cognitive mechanisms (e.g., diminished future 
time perspective), and determine whether change in FoR is related to change in medication 
adherence. We will enroll N = 100 patients within 6 weeks of first presenting to the emergency 
department with suspected acute coronary syndrome who reported elevated early symptoms 
indicative of risk of developing PTSD (threat perceptions) at the time of their emergency 
department visit.11 In all participants, we will measure FoR using the Concerns About 
Recurrence Scale (which we have adapted for ACS).13 We will also measure future time 
perspective using an assay from the SOBC measures repository: the Future Time Perspective 
Scale,14 to test their association with FoR and nonadherence. Prior to discharge, we will 
randomize patients to receive a computerized cognitive-affective FoR intervention [8 sessions 
(30 min/session; 2/week for 4 weeks)13 or control task, to test whether the intervention reduces 
FoR. The brief intervention has successfully reduced FoR in cancer patients. It trains patients to 
attend away from threatening disease-related cues (e.g., looking away from the word recurrence 
and instead toward a neutral word such as categories) and to make benign interpretations of 
ambiguous, potentially disease-related information (e.g., fatigue reflects lack of sleep, not ACS 
recurrence). Finally, we will test whether the intervention (and/or improvement in FoR) is 
associated with greater electronically-measured adherence to aspirin or other heart medications, 
including non-aspirin antiplatelet, beta-blockers, or statins, in the 2 months after discharge.  
 

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Specific Aim 1: To measure FoR in ACS patients, and test its associations with ACS-induced 
PTSD, diminished future time perspective, nonadherence to medications, and lack of physical 
activity.  
 
Specific Aim 2: To test whether a cognitive-affective intervention reduces FoR in ACS patients.  
 
Specific Aim 3: To test whether patients randomized to the intervention are more adherent to 
aspirin in the 2 months after discharge for ACS, and secondarily, whether any intervention effect 
is explained by reduced FoR.  
 
Exploratory Aim 1: We will test for off-target intervention effects on future time perspective, as 
well as the alternative mediation path through improvement in future time perspective.  
 
Exploratory Aim 2: We will test whether the intervention is associated with greater increases in 
physical activity relative to the control group and whether this association is mediated by 
changes in FoR or future time perspective.  
 
Half of ACS patients are nonadherent to secondary prevention medications within 1 year of their 
ACS event, and so are at increased ACS recurrence and mortality risk.15 PTSD symptoms are 
associated with nonadherence after acute cardiovascular events, and our work suggests that FoR 
may underlie that association. This will be the first study to identify (and perhaps modify) 
cognitive/affective mechanisms of adherence behavior in patients at high risk for ACS 
recurrence and mortality. Physicians routinely magnify patients’ FoR after acute life-threatening 
medical events to capitalize on the “teachable moment.” This study may provide evidence for the 
opposite approach, as well as validated measures to assess FoR in CVD patients. 
 
2. Study Design  
We will enroll 100 English- and Spanish-speaking patients (50 intervention group, 50 
control group) who recently presented to the ED of the New York Presbyterian Hospital 
(NYPH) with a probable admitting diagnosis of acute coronary syndrome (ACS). 
Specifically, eligible participants will be patients already enrolled in a separate approved 
protocol (IRB-AAAR7350: “Testing biopsychosocial mechanisms of the posthospital 
syndrome [PHS] model of early rehospitalization in cardiac patients”) who presented to the 
NYPH ED with chest pain and an admitting diagnosis of non-ST-elevation myocardial 
infarction (NSTEMI) or unstable angina (UA). Prior to enrollment in that separate study, 
participants will have verbally confirmed with the caregiving physician that they were not 
active substance abusers, demented, and/or psychotic. Patients will not be eligible for the 
present study unless they indicated during the consent procedure for that separate protocol 
that they were willing to be contacted about participating in a different study. In terms of 
timing, patients who consented to the PHS study within the last 6 weeks (i.e., 42 days) will 
be potentially eligible for the present study. 
 
The fundamental components of the study design are described below (see Procedure 
section for more details). One to three bilingual (English/Spanish) research assistants 
(RAs) assist in data collection at each session.  
 

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Study recruitment occurs primarily in the hospital after the potentially eligible patients 
(those currently enrolled in the separate protocol AAAR7350 and interested in learning 
more about other research studies) have been admitted to the hospital and transferred to an 
inpatient bed. For some patients, study recruitment may occur post-discharge, up to 6 
weeks following participants’ presentation to the Emergency Department when they 
enrolled in the PHS study. Research coordinators for the present protocol will approach 
these patients, introduce the study and begin the informed consent process. Consenting 
participants are randomized to the intervention or control condition and complete baseline 
measures for the present protocol at the pre-training session (i.e., Time 1). Participants are 
given an electronic tablet device and a brief training on its use at the end of or within 
several days of this baseline session. For the subset of patients who provide signed consent 
and the brief tablet training for this intervention study in the hospital but who are then 
discharged prior to this session, the Time-1 session is conducted by phone while the 
patients are at home. An additional subset of patients who consent to participate in this 
study will come to CUMC after hospital discharge to conduct the questionnaires and the 
brief tablet training of the pre-training session (i.e., Time 1) in person. All participants then 
complete 8 sessions of the training (intervention or control version) at home twice per 
week for 4 weeks using the tablet. During this time their adherence to a heart medication is 
monitored using eCAP devices that they receive during enrollment or in the mail. For 
participants currently prescribed aspirin but no other heart medication, their adherence to 
aspirin will be monitored using the eCAP devices. For participants not currently prescribed 
aspirin but who are currently prescribed a heart medication other than aspirin, such as a 
non-aspirin antiplatelet, a beta-blocker, a statin, or an antihypertensive medication, their 
adherence to this other heart medication is monitored using the eCAP devices. Within 
several days following the completion of the 4-week training, participants are then 
contacted by phone for the post-training session (i.,e., Time 2), during which they 
complete the same measures as completed at the Time-1 session. Then, participants return 
the tablet devices to CUMC researchers using pre-addressed envelopes/packages mailed to 
their homes. Finally, at 8 weeks after the Time-1 session, participants return the eCAP 
medication adherence monitoring devices to CUMC researchers also using pre-addressed 
envelopes/packages boxes. 
 
Participants must meet inclusion and exclusion criteria, as specified below. 
 
Inclusion criteria 
(1) Age 18 years or older 
(2) Fluent in English or Spanish 
(3) A diagnosis of suspected acute coronary syndrome (ACS) 
(4) Currently enrolled in the protocol titled “Testing biopsychosocial mechanisms of 
the posthospital syndrome [PHS] model of early rehospitalization in cardiac 
patients” (IRB-AAAR7350) 
(5) Previously indicated “YES” to the following question in the consent form for the 
separate protocol (IRB-AAAR7350) in which they are enrolled: “I am willing to be 
contacted about other future research projects.” 
(6) Elevated Threat Perception score in emergency department (or, if not available, 
then elevated Recollected Threat Perception score in emergency department using a 

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separate post-emergency department questionnaire) flagged by automatic scoring 
(i.e., ≥ 8, the upper 75% of 1,000 ACS patients in a separate sample) 
(7) Currently on a daily aspirin regimen prescribed by a doctor OR currently on a daily 
non-aspirin antiplatelet (e.g., Plavix), beta-blocker, statin, or anti-hypertensive 
regimen prescribed by a doctor 
(8) Some comfort using technology such as electronic tablets or smartphones 
(9) Time elapsed since emergency department visit at which they enrolled in the PHS 
study is less than 6 weeks 
 
Exclusion criteria 
(1) Deemed unable to comply with the protocol (either self-selected or by indicating 
during screening that s/he could not complete all requested tasks). This includes 
patients with a level of cognitive impairment indicative of dementia and patients with 
current alcohol or substance abuse 
(2) Deemed to need immediate psychiatric intervention (that is, has to be hospitalized 
or have some other psychiatric intervention within 72 hours) 
(3) Unavailable for follow-up. This includes patients with a terminal noncardiovascular 
illness (life expectancy less than 1 year by physician report) and those who indicate 
they are about to leave the United States 
(4) Underwent a surgical procedure within the past 24 hours and/or is scheduled for a 
surgical procedure within the next 24 hours 
 
The training sessions are administered by participants via the tablet devices twice per week 
for 4 weeks. The design of the training is described below separately for both conditions: 
intervention and control. 
 
Cognitive-Affective Training (8 at-home sessions; 30 minutes each)  
 
Cognitive bias modification for attention (CBM-A) 
 
Intervention version: In this modified dot probe task,26 CBM-A trials in the intervention 
are designed to reinforce attention away from ACS threat-related stimuli (e.g., “death,” 
“heart attack”) and toward neutral stimuli (e.g., “diets,” “vacuum cleaner”). Threat-related 
and neutral word pairs are matched on approximate number of characters and frequency of 
use in English and Spanish, at a fourth grade reading level per the Flesch-Kincaid 
readability statistic. This task consists of 160 trials (130 training trials, 30 test trials). Each 
trial begins with one pair of threat-neutral words for 500 ms. Each word occupies either the 
top or bottom portion of the screen with randomized location. Next a target screen appears 
that consists of a single letter (E or F) appearing in either the top or bottom location. 
Participants’ task is to respond as quickly and accurately as possible by tapping one of two 
buttons on the tablet screen to indicate whether they see E or F. For participants in the 
intervention group, in the 130 training trials of the task, the location of the target letter (i.e., 
top or bottom) is always the location previously occupied by the neutral word. The other 
30 trials of the task are test trials that are randomly interspersed among the training trials. 
For half of the test trials, the location of the target letter is the location previously occupied 
by the threat-related word, and for the other half of the test trials, the location of the target 

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letter is the location previously occupied by the neutral word. Thus, participants in the 
intervention group are reinforced for attending to the neutral word and away from the 
threat-related word on 90.6% of trials (145/160).  
 
Control version: For participants in the control group, in the 130 training trials of the task, 
the location of the target letter (i.e., top or bottom) is equally likely to be the location 
previously occupied by the threat-related word and the neutral word. The 30 test trials for 
the control group are identical to the test trials for the intervention. Example trial from 
intervention group (see above). Thus, participants in the control group are not reinforced 
for attending to either particular kind of stimuli. For each administration of the task, 
preferential attentional allocation toward threat-related information is assessed as the mean 
response time for test trials in which the target location is congruent with the threat-related 
word subtracted from the mean response time for test trials in which the target location is 
incongruent with the threat-related word. In this way, as a manipulation check, we will 
assess the extent to which attentional allocation to threat diminishes as a function of group 
and session (1-8) over the course of the 8 training sessions.  
 
Cognitive bias modification for interpretation (CBM-I) 
 
Intervention version: CBM-I trials are designed to train participants to appraise ambiguous 
information that is potentially related to ACS threat as benign. Each of 100 trials begins 
with a word or short phrase corresponding to either a threatening (e.g., “dying”) or benign 
(e.g., “sleep”) interpretation of a sentence that follows it (e.g., “You have been waking up 
tired recently”). On the next screen participants are asked to tap one of two buttons on the 
screen of the tablet to indicate “Yes” or “No” in response to the question “Was the word or 
phrase related to the sentence?” Participants in the intervention group receive positive 
feedback (“You are correct!”) for rejected threat interpretations or for benign 
interpretations, and otherwise they receive negative feedback (“You are incorrect”).  
 
Control version: Participants are equally likely to receive positive or negative feedback for 
endorsing or rejecting threat interpretations or for endorsing or rejecting benign 
interpretations. For each administration of the task, the tendency to make threat 
interpretations is assessed as the proportion of threat endorsements (i.e., “Yes” responses) 
on trials with threat-related words, and the tendency toward benign interpretations is 
assessed as the proportion of benign endorsements on trials with benign words. 
Additionally, we will assess threat rejection time (i.e., mean speed of responding “No” on 
trials with sentences preceded by a threat-related word).  
 
Measures 
 
Fear of recurrence (FoR) of ACS. We have adapted the Concerns about Recurrence Scale 
(CARS)13 for ACS. This multidimensional scale was originally designed to measure fear of 
recurrence of breast cancer. This adapted scale comprises 26 items evaluating three 
specific components of FCR. The health worries subscale evaluates fears about declining 
health (e.g., “I worry that a recurrence of a heart problem would threaten my physical 
health”). The role worries subscale evaluates fears about impaired relationships with other 

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people (e.g., “I worry that a recurrence of a heart problem would keep me from fulfilling 
my responsibilities”). The death worries subscale evaluates fears about mortality (e.g., “I 
worry that a recurrence of a heart problem would threaten my life”). Each item is rated on 
a Likert scale ranging from 0 (not at all) to 4 (extremely). A total score can be obtained for 
each subscale and for the total scale by summing the items. A higher score indicates higher 
levels of FoR. 
 
Future time perspective. An exploratory aim of the study is to determine the relationships 
among FoR and medication adherence with future time perspective. Patients with cardiac-
induced PTSD often report that their sense of the future is foreshortened, and prior 
conceptualizations of PTSD emphasized this sense.7 This sense of a foreshortened future 
has been shown to strongly predict PTSD diagnosis in a population of patients with 
multiple sclerosis, and may be similarly associated with both PTSD and nonadherence in 
ACS patients.16  
 
If PTSD, FoR, or both are also associated with diminished future time perspective, patients 
may value future life goals (e.g., maintain long-term heart health by taking aspirin daily) 
less than more immediate goals (e.g., avoid distressing reminders of past trauma and future 
mortality), with predictable consequences for health behaviors. Behavioral economics 
research suggests that diminished future perspective is associated with lower medication 
adherence among patients with hypertension and diabetes.17 We will explore the 
associations among PTSD, FoR, and a measure from the SOBC measures repository that 
assesses time perspective; the 10-item self-reported Future Time Perspective Scale assesses 
the extent to which participants conceive of the future as relatively limited or open-
ended.14 
 
Medication adherence. We measure adherence to aspirin objectively using eCAPS 
(Information Mediary Corp., Ottawa, Canada). Medication bottles with these special caps 
automatically record the date and time of bottle openings. Medication adherence across a 
unit of time (e.g., 1 week, 1 month) is computed as the proportion of days that participants 
took the correct number of aspirin pills. If patients are taking aspirin and other heart 
medications (i.e., non-aspirin antiplatelets, beta-blockers, statins, or antihypertensives), 
then the aspirin will be the heart medication they will place in the eCAP bottle to be 
monitored. However, if patients are taking other heart medications (i.e., non-aspirin 
antiplatelets, beta-blockers, statins, or antihypertensives) but not aspirin, then they will 
choose which one medication (either a non-aspirin antiplatelet, beta-blocker, statin, or 
antihypertensive) to put in the eCAP bottle to be monitored. 
 
Threat Perceptions. In a separate protocol we measure perceptions of threat, which are 
very early indicators of PTSD symptoms at the emergency department.11 This measure is 
used as part of the eligibility criteria (see above).  
 
Context sensitivity. We measure participants’ ability to identify information about stressful 
situations that is helpful for the successful and flexible regulation of distress. The Context 
Sensitivity Index (CSI) presents hypothetical scenarios and asks participants to answer 
questions about them (e.g., “How much control do you have over what happens next?”).12  

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3. Statistical Procedures  
 
Analysis Plan 
 
Specific Aim 1.  
To measure FoR in ACS patients, and test its associations with ACS-induced PTSD, diminished 
future time perspective, and nonadherence to medications.  
We will test the extent to which the hypothesized measures of the behavior change mechanisms 
in question (FoR, future time perspective) are intercorrelated in ACS patients with elevated acute 
stress symptoms. First, to test convergent validity, we will assess zero-order correlations among 
these measures. Specifically, we predict that—across both groups at Time 1 before the 
intervention—higher FoR will be associated with lower future time perspective (i.e., lower 
FTPS). Second, we will test whether higher FoR is associated with higher threat perception 
symptoms and overall lower proportion of days adherent to aspirin. Third, due to the within-
subjects design, we will also assess test-retest reliability from Time 1 to 2, both across and within 
groups. In this way we will ensure that we have valid and reliable measures of our proposed 
mechanisms of behavior change. 
 
Specific Aim 2. 
To test whether a cognitive-affective intervention reduces FoR in ACS patients.  
We will conduct a univariate ANOVA to assess the effect of the four-week intervention on pre-
to-post change in FoR, the proposed target mechanism. Prior intervention research in cancer 
patients showed a small to moderate effect size of a cognitive-affective intervention on FoR 
symptoms (Hedge’s g for difference in health worries from pre- to post-intervention = 0.35). In 
separate unadjusted tests with pre-to-post change in FoR (and in an exploratory test of future 
time perspective) as the outcome, we will enter group (intervention, control) as the predictor. We 
will repeat the tests adjusting for factors that may explain variance in health behavior, including 
demographic information (age, sex, race, ethnicity), medical severity assessed by GRACE risk 
score18 and Charlson comorbidity index,19 and depressive symptoms assessed by PHQ-8 score.20 
 
Specific Aim 3. 
To test whether patients randomized to the intervention are more adherent to aspirin in the 2-
month monitoring period within the first several months after their suspected ACS event, and 
secondarily, whether any intervention effect is explained by reduced FoR. 
We will test this mediational hypothesis using conditional process modeling with the PROCESS 
macro in SPSS.21 Although we will likely have insufficient power to test the question 
definitively, the results will inform whether a future larger trial is warranted. The behavioral 
outcome in the model is heart medication adherence from the eCAP data: mean proportion of 
adherent days in the 2-month monitoring period that occurs within several months after hospital 
discharge. The predictor is group (intervention, control). The mediator is pre-to-post change in 
FoR from Time 1 to 2. For a secondary analysis, we will test the outcome as the magnitude of 
the slope of change in weekly proportion of adherent days during the 2 months. We will evaluate 
whether there is a significant indirect effect that supports the notion that the intervention vs. the 
control training engaged the target mechanism in such a way that changes in the target predicted 
improved heart medication adherence over the month-long intervention. 

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Exploratory Aim 1. 
We will test for off-target intervention effects on future time perspective, as well as the 
alternative mediation path through improvement in future time perspective.  
The test will be structured as for Specific Aim 3 but with pre-to-post change in future time 
perspective as the tested mediator. 
 
Exploratory Aim 2. 
We will test whether the intervention is associated with greater increases in physical activity 
relative to the control group and whether this association is mediated by changes in FoR or 
future time perspective.   
The test will be structured as for Specific Aim 3 and Exploratory Aim 1 but with physical 
activity as the tested behavioral outcome measure instead of medication adherence. 
 
Power analysis. 
In prior research with N = 97 at Time 1 using a similar intervention in cancer patients, a 
moderate effect size (Hedges g = 0.54) was found for differences in FoR between the 
intervention (n = 64) and control (n = 36) groups after 3 months and a somewhat smaller effect 
size (Hedge’s g = 0.35) immediately after the 1-month intervention.13 Using G*Power 3.1,22 we 
tested a range of effect sizes for two levels of power. We determined that the present study is 
conservatively powered to change FoR in a fixed-effects one-way ANOVA with an effect size f 
of 0.35 or larger with a sample size of N = 100 (50 intervention, 50 control), given alpha = .05 
and an intention-to-treat design in which missing data due to attrition are handled with multiple 
imputation. 
 
4. Study Procedures 
 
Patients will be considered for enrollment in the present study who are currently enrolled in 
AAAR7350 (the PHS study), who signed consent for AAAR7350 within the last 6 weeks (i.e., 
42 days), who have indicated they are willing to hear about other research studies, and who have 
an Elevated Threat Perception score.  Consent will be obtained using an IRB-approved consent 
form.  
 
Pre-training/Time 1: For patients consenting to the study in the hospital, the pre-training session 
ideally occurs at this same visit. The RA will assess the potential mechanisms of behavior 
change verbally. At the end of this session, each patient will be given a tablet and an eCAP bottle 
with a brief explanation of their use. The estimated duration of this session is 45 minutes, 
including the consent process, questionnaires, and the brief training in the use of the tablet. A 
subset of patients will complete the consent process and receive the devices (eCAP bottle, tablet) 
with a brief training in the hospital and will then separately complete the questionnaires verbally 
by phone within several days. A separate subset of patients will complete the Time-1 session at 
CUMC sometime after hospital discharge but before 6 weeks (i.e., 42 days) have elapsed from 
the time of consent to the protocol AAAR7350. 
 
Training phase: Random group assignment to the intervention or control group will be 
determined in a double-blind way by the programmed tasks on the tablet for each participant. 

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Participants are asked to complete 8 at-home 30-minute intervention sessions (both CBM-A and 
CBM-I tasks are programmed to occur sequentially in one session). The schedule of sessions is 2 
times per week. Participants will receive brief, automated text messages 2 times each week 
reminding them to complete these sessions. Phone calls will be conducted instead of text 
messages for participants without text message capability or for particular scheduled training 
sessions when participants do not respond to the text reminders. 
 
Post-training/Time 2: A clinical coordinator will administer the measures by phone interview. 
Participants who prefer a home visit may complete the session in person and return their tablet to 
the interviewing clinical coordinator at that time. The estimated duration of this session is 45 
minutes. All other participants will return their tablets and eCAP bottles via mail: one pre-
addressed envelope/ package for the return of the tablet at 4 weeks after the Time-1 session and 
soon after completion of the Time-2 session and one separate pre-addressed envelope/package 
for the return of the eCAP bottle at 8 weeks after the Time-1 session.  
 
Monetary compensation is administered via pay card in two installments. In the first installment 
of monetary compensation, participants receive $20 at Time 1. Regarding the second installment 
of monetary compensation, it is structured such that participants are incentivized to return their 
devices with complete data. They receive $5 for completing the 1st at-home tablet tasks session, 
$5 for the 2nd, $5 for the 3rd, $5 for the 4th, $10 for the 5th, $10 for the 6th, $20 for the 7th, and $20 
for the 8th tablet tasks session. They receive $20 for completing the Time 2 interview. The 
second study compensation is contingent upon return of the tablet following Time 2. Finally, in 
the third study compensation, participants receive $20 for returning the eCAP device. Thus, total 
study compensation for participants who complete all sessions is $140 ($20 in first installment + 
up to $100 in second installment + $20 in third installment). 
 

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