Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change

NCT03853213 | Completed Results

• 2 other identifiers: AAAR9458R21HL145970-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Fear; Medication Adherence

Keywords

Fear of Recurrence; Acute Coronary Syndrome; Intervention; Cognitive Bias Modification Training; Attentional Bias; Interpretation Bias; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Change in Total Score for Concerns About Recurrence Scale [Adapted for Acute Coronary Syndrome]

  This 19-item self-report scale measures fear of recurrence of ACS events. It uses a 5-point Likert scale (0 to 4). It has three subscales: health worries (items 1-11; subscale range: 0-44), role worries (items 12-17: subscale range: 0-24), and death worries (items 18-19: subscale range: 0-8). The total score is computed as the sum of all items in the scale (total score range: 0 to 76). Higher total scores indicate greater fear of recurrence. The study will test whether there is a larger Time-1-to-Time-2 reduction in Concerns about Recurrence total scores for the intervention group relative to the control group. The outcome for each group is computed as mean of the difference of the Time-2 score minus the Time-1 score. This is the sole primary outcome because the trial design was statistically powered to reduce FoR.

  Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)

Secondary Outcomes (5)

• Total Score for Self-reported Extent of Nonadherence to Medication From the Extent of and Reasons for Nonadherence Scale [Adapted]

  Post-Training/Time 2 (approximately 4 weeks after Time 1)

• Change in Total Score for the International Physical Activity Questionnaire in MET Minutes/Week

  Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)

• Change in Cue Presence Score for the Context Sensitivity Index

  Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)

• Change in Total Score for Future Time Perspective Scale

  Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)

• Percentage of Adherent Days to Medication (Aspirin, Beta-blocker, or Statin)

  Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2)

Study Arms (2)

Cognitive Bias Modification Training

EXPERIMENTAL

Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., "death," "chest pain") and toward neutral stimuli (e.g., "curve," barn doors"). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.

Behavioral: Cognitive Bias Modification Training

Attention Control Training

SHAM COMPARATOR

Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.

Behavioral: Attention Control Training

Interventions

Cognitive Bias Modification Training BEHAVIORAL

In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., "dying") or benign (e.g., "sleep") interpretation of a sentence (e.g., "You have been waking up tired recently"). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback ("Correct") is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback ("Incorrect") is given.

Also known as: Cognitive-Affective Fear of Recurrence Intervention

Cognitive Bias Modification Training

Attention Control Training BEHAVIORAL

In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations.

Attention Control Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NewYork-Presbyterian/Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Lopez-Veneros D, Cumella R, Kronish IM, Lazarov A, Birk JL. Home-based cognitive bias modification training for reducing maladaptive fear in patients with suspected acute coronary syndrome: a pilot randomized clinical trial. Pilot Feasibility Stud. 2024 Jan 11;10(1):7. doi: 10.1186/s40814-024-01442-2.

  PMID: 38212853 DERIVED

• Birk JL, Cumella R, Lopez-Veneros D, Jurado A, Romero EK, Lazarov A, Kronish IM. Intervening on fear after acute cardiac events: Rationale and design of the INFORM randomized clinical trial. Health Psychol. 2020 Sep;39(9):736-744. doi: 10.1037/hea0000853.

  PMID: 32833475 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Because New York City was the original epicenter of the COVID-19 outbreak in the US, the pandemic brought study enrollment to a halt in March 2020. Our potential pool of participants from the parent study also slowed due to the implementation of a new test (high sensitivity cardiac troponin assay) to diagnose ACS in the emergency department. Although beneficial for patient treatment, it reduced the number of patients enrolled in the parent study.

Results Point of Contact

• Title: Dr. Jeffrey Birk
• Organization: Columbia University Irving Medical Center

jlb2287@cumc.columbia.edu

212-342-5503

Study Officials

• Jeffrey L Birk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medical Sciences

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: March 28, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: September 17, 2021
• Results First Posted: July 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)