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Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change (INFORM)

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ClinicalTrials.gov Identifier: NCT03853213
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Birk, Columbia University

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 acute coronary syndrome (ACS) patients. 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Fear Medication Adherence Behavioral: Cognitive Bias Modification Training Behavioral: Attention Control Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: Cognitive Bias Modification Training
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
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.
Other Name: Cognitive-Affective Fear of Recurrence Intervention

Sham Comparator: Attention Control Training
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
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.




Primary Outcome Measures :
  1. Change in Total Score for Concerns about Recurrence Scale [Adapted for Acute Coronary Syndrome] [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    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. This is the sole primary outcome because the trial design was statistically powered to reduce FoR.


Secondary Outcome Measures :
  1. Total for self-reported extent of nonadherence to medication from the Extent of and Reasons for Nonadherence Scale [Adapted] [ Time Frame: Post-Training/Time 2 (approximately 4 weeks after Time 1) ]
    The self-reported scale called the Extent of and Reasons for Nonadherence Scale [Adapted] measures how often participants do not take their prescribed medication and the reasons that they were nonadherent (e.g., forgot, out of routine, feeling down or upset). The measure of extent of nonadherence is the total of all 5 items in the extent portion of the scale such that higher scores represent greater nonadherence (total score range: 5-25). The study will test whether there are lower self-reported extent of nonadherence scores for the intervention group relative to the control group at time 2. (Because not all participants are expected at time 1 to have been already taking the particular heart medication assessed in the study, the self-reported questions about medication adherence are only administered at time 2.)

  2. Change in total score for the International Physical Activity Questionnaire in MET minutes/week [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This 7-item self-report scale measures the extent to which participants engaged in physical activity at a variety of intensity levels during the last week. Higher scores represent greater total metabolic equivalent of task (MET) minutes of physical activity per week based on the following estimates: 3.3 MET units for walking, 4.4 MET units for moderate activity, 8 MET units for vigorous activity. The study will test whether there is a larger Time-1-to-Time-2 increase in total scores on the International Physical Activity Questionnaire (units: MET minutes/week) for the intervention group relative to the control group.

  3. Change in cue presence score for the Context Sensitivity Index [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This self-report scale measures participants' ability to identify information about stressful situations that may be helpful for successfully and flexibly regulating unpleasant feelings of distress. In particular, the cue presence score reflects the sensitivity to the presence of meaningful contextual cues. This cue presence score is calculated as the sum of 10 relevant items from the scale. Greater cue presence scores indicate greater context sensitivity (cue presence score range: 10-77). The study will test whether there is a larger Time-1-to-Time-2 increase in cue presence scores on the Context Sensitivity Index for the intervention group relative to the control group.

  4. Change in total score for Future Time Perspective Scale [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This 10-item self-reported scale measures participants' perceptions of their own futures as either limited (lower scores) or expansive (higher scores). The total score is the sum of all 10 items after three of the items (8-10) have been reverse-coded (total score range: 10-77). The study will test whether there is a larger Time-1-to-Time-2 increase in Future Time Perspective total scores for the intervention group relative to the control group.

  5. Proportion of adherent days to medication (aspirin, beta-blocker, or statin) [ Time Frame: Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2) ]
    Participants' post-hospitalization medication adherence is measured objectively through electronically recorded pill bottle openings using the eCAP device (Information Mediary Corp., Ottawa, Canada). The measure is operationalized as the proportion of adherent days. The study will test whether there is a higher proportion of adherent days across the entire study monitoring period for the intervention group relative to the control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853213


Contacts
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Contact: Jeffrey L Birk, PhD 212-342-5503 jlb2287@cumc.columbia.edu
Contact: Ian M Kronish, MD, MPH 212-342-1335 ik2293@cumc.columbia.edu

Locations
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United States, New York
NewYork-Presbyterian/Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jeffrey L Birk, PhD    212-342-5503    jlb2287@cumc.columbia.edu   
Principal Investigator: Jeffrey L Birk, PhD         
Sub-Investigator: Ian M Kronish, MD, MPH         
Sub-Investigator: Joseph E Schwartz, PhD         
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeffrey L Birk, PhD Columbia University Irving Medical Center

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Responsible Party: Jeffrey Birk, Instructor in Medical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT03853213     History of Changes
Other Study ID Numbers: AAAR9458
R21HL145970-01 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Birk, Columbia University:
Fear of Recurrence
Acute Coronary Syndrome
Intervention
Cognitive Bias Modification Training
Attentional Bias
Interpretation Bias
Medication Adherence

Additional relevant MeSH terms:
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Syndrome
Recurrence
Acute Coronary Syndrome
Disease
Pathologic Processes
Disease Attributes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases