NCT03853213|CompletedResults
Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change
INFORM
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INFORM
Sponsor study identifier
Secondary identifiers
interventional
26
1 country
1
Study Start
March 28, 2019
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
July 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2019
Actual (reported)February 25, 2019
Actual (reported)March 28, 2019
Actual (reported)June 30, 2020
Actual (reported)July 31, 2020
Actual (reported)July 26, 2021
Actual (reported)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)
Total Score for Self-reported Extent of Nonadherence to Medication From the Extent of and Reasons for Nonadherence Scale [Adapted]
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.
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.
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.
NewYork-Presbyterian/Columbia University Irving Medical Center
New York, New York, 10032, United States
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.
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.
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.
Jeffrey L Birk, PhD
Columbia University
26 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2019
First Posted
February 25, 2019
Study Start
March 28, 2019
Actual (reported)Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
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)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 30, 2020
Actual (reported)Study Completion
July 31, 2020
Actual (reported)Last Updated
September 17, 2021
Results First Posted
July 26, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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