Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change

Acute coronary syndrome (ACS; myocardial infarction or unstable angina) is a leading cause of
morbidity and mortality in the U.S., with >1 million cases per year. Survivors are at high
risk for recurrent cardiovascular disease (CVD) events, particularly if they do not adhere to
risk-reducing medications. Unfortunately, nonadherence among ACS patients is very common
(~50%), and no effective, scalable interventions exist. Addressing medication nonadherence in
ACS patients requires an experimental medicine approach to identify specific mechanisms of
behavior change in populations for whom those mechanisms are most relevant and modifiable.

Accumulating evidence suggests that the many patients who develop post-traumatic stress
disorder (PTSD) symptoms following ACS view their medications as reminders of their cardiac
event and their future CVD risk. Ironically, although it has rarely been studied outside of
cancer survivors, this fear of recurrence (FoR) may undermine medication adherence in ACS
patients. This project will use the Science of Behavior Change (SOBC) experimental medicine
approach to investigate FoR as a putative mechanism of behavior change with respect to heart
medication adherence among ACS patients with early PTSD symptoms at hospital discharge. The
study will test a cognitive-affective intervention that has been shown to reduce FoR in
cancer survivors, that is delivered electronically (electronic tablet) in the patient's home.
The intervention has been adapted in this study for ACS to be tested using a double-blind
randomized controlled design. One hundred ACS patients will be enrolled with high acute
stress disorder symptoms at discharge. FoR and future time perspective will be assessed at
inpatient bedside, and then participants will be trained on the tablet intervention.
Participants will complete the intervention over four weeks in eight half-hour sessions,
twice each week. Medication adherence will be measured electronically using eCAP devices. FoR
and future time perspective will be reassessed at 1 month follow up, and cognitive-affective
change will be assessed electronically throughout the intervention period.

The associations among ACS-induced PTSD, FoR, and future time perspective will be estimated,
as well as their association with medication adherence. The study will also assess whether
the intervention successfully engages the target mechanism (FoR). Finally, it will test
whether the intervention improves adherence in the 2 months after hospital discharge, and
whether any intervention effect is due to reduction in FoR. This will be the first study to
identify, and perhaps modify, a cognitive/affective mechanism of adherence behavior in ACS
patients at high risk for ACS recurrence and mortality.

Inclusion Criteria:

1. Age 18 years or older;

2. Fluent in English or Spanish;

3. A diagnosis of NSTEMI or UA according to American College of Cardiology criteria;

4. Currently enrolled in the protocol titled "Testing biopsychosocial mechanisms of the
posthospital syndrome [PHS] model of early rehospitalization in cardiac patients"
(IRB-AAAR7350 at CUIMC)

5. Previously indicated "YES" to the following question in the consent form for the
separate protocol (IRB-AAAR7350) in which they are enrolled and willing to be
contacted about other future research projects.

6. Elevated Threat Perception score in emergency department flagged by automatic scoring
(i.e., ≥ 10, the median for 1,000 ACS patients in a separate sample)

7. Currently on a daily aspirin regimen prescribed by a doctor OR currently on a daily
beta-blocker or statin regimen prescribed by a doctor

8. Some comfort using technology such as electronic tablets or smartphones

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.