Acute Coronary SyndromeINFORMNCT03853213
Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change
A study testing Cognitive Bias Modification Training in people with Acute Coronary Syndrome and Fear, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Fear, Medication Adherence
- What is being tested?
- Cognitive Bias Modification Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian/Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
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.
Read the detailed description
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 suspected ACS patients will be enrolled who reported at least mild to moderate threat perceptions at the time of their initial visit to the emergency department. FoR and future time perspective will be assessed within six weeks of the initial visit to the emergency department, 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 1 month after the baseline session, and cognitive-affective change will be assessed electronically throughout the intervention period.
In addition to investigating FoR as the primary mechanism of behavior change, the study also investigates a secondary potential mechanism that is a distinct, but related, construct: future time perspective. Furthermore, in addition to examining medication adherence as the primary health behavior of interest, the study also examines a secondary health behavior that is reduced in fearful cardiac patients: physical activity. Collectively, the three aims below address these two putative mechanisms (FoR, future time perspective) and these two health behaviors (medication adherence, physical activity) in the randomly assigned groups (intervention, control).
Objectives
Aim 1 (main purpose of the trial):
The study will determine whether a tablet-based cognitive bias modification treatment (CBMT) intervention influences the two putative mechanisms of fear of recurrence (FoR) and future time perspective. Of primary importance within this first aim, it will test whether the intervention reduces cardiac-related FoR relative to control. The trial is statistically powered to test the first aim as it relates to FoR. Secondarily, it will also test whether the intervention increases an expansive future time perspective relative to control.
Aim 2 (exploratory):
The study will determine the extent to which the two potential mechanisms of behavior change-FoR and future time perspective-are each associated with health behaviors. Of primary importance within this second aim, it will test associations between these two potential mechanisms of behavior change and objectively measured and self-reported adherence to heart medications (antiplatelets to reduce risk of blood clotting, antihypertensive drugs to reduce blood pressure, or statins to lower cholesterol). Of secondary importance, it will test whether these two potential mechanisms of behavior change are associated with self-reported physical activity.
Aim 3 (exploratory):
The study will test whether the intervention improves the two health behaviors of interest. Of primary importance within this third aim, it will test whether the intervention relative to control is associated with higher heart medication adherence (objectively measured or self-reported) in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective. Secondarily, it will test whether the intervention relative to control is associated with greater increases in self-reported physical activity in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective.
- Conditions
- Acute Coronary Syndrome, Fear, Medication Adherence
- Being tested
- Cognitive Bias Modification Training, Attention Control Training
- Keywords
- Fear of Recurrence, Acute Coronary Syndrome, Intervention, Cognitive Bias Modification Training, Attentional Bias, Interpretation Bias, Medication Adherence
- Medical subject headings
- Acute Coronary Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias Modification TrainingBehavioural
Also called Cognitive-Affective Fear of Recurrence Intervention
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.
Attention Control TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
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 3 items in the extent portion of the scale such that higher scores represent greater nonadherence (total score range: 3-15). 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.)
Measured: Post-Training/Time 2 (approximately 4 weeks after Time 1)
Change in Total Score for the International Physical Activity Questionnaire in MET Minutes/Week
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. The outcome for each group is computed as mean of the difference of the Time-2 score minus the Time-1 score.
Measured: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
Change in Cue Presence Score for the Context Sensitivity Index
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. The outcome for each group is computed as mean of the difference of the Time-2 score minus the Time-1 score.
Measured: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
Change in Total Score for Future Time Perspective Scale
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. The outcome for each group is computed as mean of the difference of the Time-2 score minus the Time-1 score.
Measured: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
Percentage of Adherent Days to Medication (Aspirin, Beta-blocker, or Statin)
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 percentage of adherent days. The study will test whether there is a higher percentage of adherent days across the entire study monitoring period for the intervention group relative to the control group.
Measured: Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start28 Mar 2019
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeffrey Birk, Columbia University
- Investigators
- Jeffrey L Birk, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853213
- Sponsor's protocol ID
- AAAR9458
- Other IDs
- R21HL145970-01
- Acronym
- INFORM
- Status last verified
- Aug 2021
- First submitted
- 22 Feb 2019
- Last updated
- 17 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38212853Birk 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.
PubMed 32833475
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT03853213
- Acronym / sponsor ID
- INFORM / AAAR9458
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Posted 26 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 suspected ACS patients will be enrolled who reported at least mild to moderate threat perceptions at the time of their initial visit to the emergency department. FoR and future time perspective will be assessed within six weeks of the initial visit to the emergency department, 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 1 month after the baseline session, and cognitive-affective change will be assessed electronically throughout the intervention period.
In addition to investigating FoR as the primary mechanism of behavior change, the study also investigates a secondary potential mechanism that is a distinct, but related, construct: future time perspective. Furthermore, in addition to examining medication adherence as the primary health behavior of interest, the study also examines a secondary health behavior that is reduced in fearful cardiac patients: physical activity. Collectively, the three aims below address these two putative mechanisms (FoR, future time perspective) and these two health behaviors (medication adherence, physical activity) in the randomly assigned groups (intervention, control).
Objectives
Aim 1 (main purpose of the trial):
The study will determine whether a tablet-based cognitive bias modification treatment (CBMT) intervention influences the two putative mechanisms of fear of recurrence (FoR) and future time perspective. Of primary importance within this first aim, it will test whether the intervention reduces cardiac-related FoR relative to control. The trial is statistically powered to test the first aim as it relates to FoR. Secondarily, it will also test whether the intervention increases an expansive future time perspective relative to control.
Aim 2 (exploratory):
The study will determine the extent to which the two potential mechanisms of behavior change-FoR and future time perspective-are each associated with health behaviors. Of primary importance within this second aim, it will test associations between these two potential mechanisms of behavior change and objectively measured and self-reported adherence to heart medications (antiplatelets to reduce risk of blood clotting, antihypertensive drugs to reduce blood pressure, or statins to lower cholesterol). Of secondary importance, it will test whether these two potential mechanisms of behavior change are associated with self-reported physical activity.
Aim 3 (exploratory):
The study will test whether the intervention improves the two health behaviors of interest. Of primary importance within this third aim, it will test whether the intervention relative to control is associated with higher heart medication adherence (objectively measured or self-reported) in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective. Secondarily, it will test whether the intervention relative to control is associated with greater increases in self-reported physical activity in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification Training | Experimental | Behavioral: Cognitive Bias Modification TrainingParticipants 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. |
| Attention Control Training | Sham comparator | Behavioral: Attention Control TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias Modification TrainingAlso: Cognitive-Affective Fear of Recurrence InterventionIn 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. | Behavioural | Cognitive Bias Modification Training |
| Attention Control TrainingIn 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. | Behavioural | Attention Control Training |
Primary outcome
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. 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.
5 secondary outcomes
Total Score 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)
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)
Change in Cue Presence Score for the Context Sensitivity Index
Time frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
Change in Total Score for Future Time Perspective Scale
Time frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
Percentage 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38212853Lopez-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.
- Derived from this study: PubMed 32833475Birk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Birk, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification Training in people with Acute Coronary Syndrome and Fear, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.