N/A
N=20
Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change
Acute Coronary Syndrome · Fear · Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT03853213 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Change in Total Score for Concerns About Recurrence Scale [Adapted for Acute Coronary Syndrome] — -5.40; -2.86 change in score on a scale — p=0.698
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Bias Modification Training (Behavioral); Attention Control Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Score for Concerns About Recurrence Scale [Adapted for Acute Coronary Syndrome] |
-5.40; -2.86 | 0.698 |
| SECONDARY Total Score for Self-reported Extent of Nonadherence to Medication From the Extent of and Reasons for Nonadherence Scale [Adapted] |
11.71; 7.83 | 0.123 |
| SECONDARY Change in Total Score for the International Physical Activity Questionnaire in MET Minutes/Week |
648.3; 714.6 | 0.965 |
| SECONDARY Change in Cue Presence Score for the Context Sensitivity Index |
0.60; -5.57 | 0.290 |
| SECONDARY Change in Total Score for Future Time Perspective Scale |
2.30; -2.77 | 0.434 |
| SECONDARY Percentage of Adherent Days to Medication (Aspirin, Beta-blocker, or Statin) |
61.78; 78.83 | 0.293 |
Summary
The primary goal of this project is to identify, measure, and influence fear of cardiac event recurrence, a candidate mechanism of change in medication adherence in patients with suspected acute coronary syndrome (ACS). An intervention will be tested that has been used to reduce fear of cancer recurrence by changing emotion-related patterns of attention allocation and interpretation of neutral stimuli. Secondarily, the study will test whether a reduction in fear of cardiac event recurrence improves medication adherence.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older;
- Fluent in English or Spanish;
- A diagnosis of NSTEMI or unstable angina (UA) according to American College of Cardiology criteria;
- 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)
- 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.
- 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)
- Currently on a daily aspirin regimen prescribed by a doctor OR currently on a daily beta-blocker or statin regimen prescribed by a doctor
- Some comfort using technology such as electronic tablets or smartphones
Exclusion Criteria
- 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;
- Deemed to need immediate psychiatric intervention (that is, has to be hospitalized or have some other psychiatric intervention within 72 hours);
- 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;
- Underwent a surgical procedure within the past 24 hours and/or is scheduled for a surgical procedure within the next 24 hours.
Data sourced from ClinicalTrials.gov (NCT03853213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.