Panic DisorderNCT04433832
Physical and Psychological Health Trajectories in the Context of Coronary Heart Disease
An observational study of Panic Disorder and Generalized Anxiety Disorder, run by Laval University at 1 site in Canada.
Trial summary
The primary aim of this study is to establish how frequently patients with coronary artery disease present or develop two anxiety disorders (panic disorder and generalized anxiety disorder) in the two years following a medical intervention for their heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Generalized Anxiety Disorder, Coronary Artery Disease
- How many people
- 3,610 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2020to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adults patients who write and speak French and who have undergone a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting) for CAD.
Who may be able to join
- All adult patients (18 years of age or older) who undergo a revascularization procedure for CAD at the Quebec Heart and Lung Institute and who write/speak French will be eligible for study participation.
Who cannot join
- Patients will be excluded if they present a severe communication problem or suffer from a terminal illness, a diagnosed major cognitive deficit, or any other condition that could invalidate the interview (e.g. psychotic disorder).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Quebec Heart and Lung Institute/Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V4G5
Guillaume Foldes-Busque, Ph.D., 418-656-2131 ext. 402592, guillaume.foldes-busque@psy.ulaval.ca
Jessica Lebel, M.A., 418-6562131 ext. 405068, jessica.lebel@psy.ulaval.ca
About this study
Official title: Epidemiology and Prognostic Implications of Panic Disorder and Generalized Anxiety Disorder in Patients With Coronary Artery Disease
The primary aim of this study is to establish how frequently patients with coronary artery disease present or develop two anxiety disorders (panic disorder and generalized anxiety disorder) in the two years following a medical intervention for their heart. A second objective is to assess the impact of these anxiety disorders on the health of these patients.
Read the detailed description
Coronary artery disease (CAD), the most common form of cardiovascular disease, affects approximately 1 in 12 adults in Canada. CAD is a major public health concern and is one of the costliest chronic diseases in North America. Up to 90% of the CAD risk is attributable to nine modifiable risk factors, including psychosocial factors. Decades of research confirmed the importance of psychosocial factors in the development, prognosis and clinical presentation of CAD. One understudied but highly significant psychosocial risk factor is anxiety. Prevalence estimates of anxiety disorders in patients with CAD range from 10% to 65%, with panic disorder (PD) and generalized anxiety disorder (GAD) being the most prevalent. Both PD and GAD have been independently associated with a 36% to 94% increase in the risk of adverse cardiac events in patients with CAD. However, these findings remain controversial as some studies reported either an inverse or no association between PD and adverse events. Still, both PD and GAD are associated with the presence of multiple risk factors for CAD (e.g. smoking, high alcohol consumption and a sedentary lifestyle). These anxiety disorders are also likely to influence medication taking behaviors as well as adherence to cardiac rehabilitation programs. These data highlight the importance and prognostic significance of PD/GAD in patients with CAD. However, considering the contradictory data and significant methodological issues in the available studies, notably in terms of the validity of PD and GAD diagnoses, new, methodologically sound studies are needed to improve our understanding of this clinical problem and improve patient care.
The primary aim of this study is to establish the prevalence and incidence of PD and GAD in the two years following a revascularization procedure for CAD. The secondary aim is to prospectively assess the association between these disorders and cardiac mortality, adverse cardiac events, adherence to recommended treatments (exercise, cardiac rehabilitation, pharmacotherapy),quality of life and psychological distress.
This prospective cohort study will include 3610 patients who will be consecutively recruited following a revascularisation procedure for CAD at the cardiology department of the Quebec Heart and Lung Institute. Patients will be assessed at baseline (within a week of admission) as well as 3, 6, 12 and 24 months later. PD and GAD will be assessed with a standardized and validated semi-structured interview. The presence of adverse events, adherence to treatments, psychological distress and quality of life will be assessed through a review of medical records, questionnaires and interviews.
- Keywords
- Coronary artery disease, Anxiety, Anxiety disorders, Prognosis, Cardiac rehabilitation, Psychosocial risk factors, Health behaviors, Treatment adherence
- Medical subject headings
- Panic Disorder, Generalized Anxiety Disorder, Coronary Artery Disease, Anxiety Disorders, Health Behavior, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Related Disorders Interview Schedule for DSM-5
Panic disorder (PD) and generalized anxiety disorder (GAD) will be assessed at each time point using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). This standardized interview protocol is one of the recommended measures for diagnosing anxiety disorders, including PD and GAD, in the research context. The PD and GAD modules of previous versions of the ADIS have demonstrated excellent reliability for their respective diagnoses.
Measured: 2 years
Adverse cardiac events
Patients will be asked about all potential adverse events during a structured medical interview developed by our team. All data will be confirmed by a review of medical records. With written permission from patients or next of kin (if deceased), records for admissions or consultations outside of the study hospitals will be obtained from the establishment archives. Medical data will be extracted by the research nurses using a standardized medical data extraction form known for its excellent reliability.
Adverse events are defined as: either an acute myocardial infarction, a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting), a cardiac arrest (including ventricular fibrillation) or death from a cardiovascular cause (primary cause).
Measured: 2 years
Secondary outcomes (11)
Medical Outcomes Study Measures of Patient Adherence
A 5-item general measure which assesses the patients' tendency to comply with medical recommendations and a second section which measures adherence to recommendations made by a healthcare professional (e.g., taking medication, following a diet) in the context of CAD. Total scores range from 0 to 25, higher scores indicate higher reported medication adherence.
Measured: 2 years
Adherence Scale in Chronic Diseases
This measure specifically assesses medication adherence and some of its potential barriers in patients with CAD or other chronic diseases. Total scores range from 0 to 32, higher scores indicate higher reported medication adherence.
Measured: 2 years
Cardiac rehabilitation participation
Patients will be asked if they participated in a formal rehabilitation program at each time point with two validated interview items. Attendance will be assessed by reviewing records of the 12-week cardiac rehabilitation programs. With written permission from patients or next of kin, records of attendance to programs outside of the study hospitals will be obtained from archives departments. Participation will be categorized as follows:
- Non-attendance: patients who did not attend a cardiac rehabilitation program.
- Level of adherence: calculated with the percentage of the prescribed sessions attended during the program.
- Completion: patients who attended at least 70% of the planned sessions.
- Discontinuation: patients who stopped attending cardiac rehabilitation at least 3 weeks before the end of the program.
Measured: 2 years
Health behaviors - Level of physical activity
Level of physical activity: This parameter will be assessed with the validated French version of the International Physical Activity Questionnaire - Short Form. This questionnaire generates an average amount of time spent per week doing physical activity across activity domains. A higher mean time represents more physical activity on average.
Measured: 2 years
Health behaviors - Smoking status
Smoking status: This variable will be assessed using the validated self-report items developed by Statistics Canada to assess the current smoking status. Smoking status will be established based on the patients' self-reported smoking behaviour in the 30 days preceding each time point. Participants can be categorized as Non-Smokers, Occasional-Smokers or Regular Smokers.
Measured: 2 years
Health behaviors - Alcohol use
Alcohol use: The patients' compliance with recommendations regarding alcohol consumption will be assessed with the first 3 items of the validated French version of the Alcohol Use Disorders Identification Test. Total scores range from 0 to 12, higher scores indicate higher alcohol use.
Measured: 2 years
Health behaviors - Fruit and vegetable intake
Fruit and vegetable intake: Patients' usual consumption of fruit and vegetables will be assessed using the 6-item Fruit and Vegetable Questionnaire (FV-Q) validated questionnaire. This questionnaire generates a mean daily consumption of fruits and vegetables. A higher mean represents more servings consumed for each specific category.
Measured: 2 years
Quality of life and psychological distress - Health-related quality of life
Health-related quality of life: The 12-item Short-Form Health Survey Version 2 (SF-12v2) will be used to assess patients Health-related quality of life.
Total scores range between 0 and 100, with higher scores indicating a better HRQOL.
Measured: 2 years
Quality of life and psychological distress - Anxiety and depressive symptoms
Anxiety and depressive symptoms will be measured with the validated French version of the Hospital Anxiety and Depression Scale.
Total scores range between 0 and 21, with higher scores indicating a higher level of anxiety/depression.
Measured: 2 years
Quality of life and psychological distress - Heart- focused anxiety
Heart- focused anxiety will be assessed with the French version of the Cardiac Anxiety Questionnaire. Total scores range between 0 and 20, with higher scores indicating a higher level of heart-focused anxiety.
Measured: 2 years
PTSD Checklist for DSM-5
The PCL-5 is a 20-item self-report questionnaire that assesses post-traumatic stress disorder (PTSD) symptoms according to DSM-5 criteria. In this study, the PCL will be used to assess symptom severity and to make a provisional PTSD diagnosis.
Total scores range between 0 and 80, with higher scores indicating a higher level of PTSD.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Jan 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Laval 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Quebec Heart Institute, CISSS de Chaudière-Appalaches
- Responsible party
- Principal investigator, Guillaume Foldes-Busque, Laval University
- Investigators
- Guillaume Foldes-Busque, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433832
- Sponsor's protocol ID
- LavalU
- Status last verified
- Oct 2020
- First submitted
- 28 May 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prognostic Implications of Panic Disorder and Generalized Anxiety Disorder in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04433832
- Acronym / sponsor ID
- LavalU
- Keywords
- Coronary artery disease, Anxiety, Anxiety disorders, Prognosis, Cardiac rehabilitation, Psychosocial risk factors, Health behaviors, Treatment adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,610 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Quebec Heart Institute, CISSS de Chaudière-Appalaches
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to establish how frequently patients with coronary artery disease present or develop two anxiety disorders (panic disorder and generalized anxiety disorder) in the two years following a medical intervention for their heart. A second objective is to assess the impact of these anxiety disorders on the health of these patients.
Detailed description
Coronary artery disease (CAD), the most common form of cardiovascular disease, affects approximately 1 in 12 adults in Canada. CAD is a major public health concern and is one of the costliest chronic diseases in North America. Up to 90% of the CAD risk is attributable to nine modifiable risk factors, including psychosocial factors. Decades of research confirmed the importance of psychosocial factors in the development, prognosis and clinical presentation of CAD. One understudied but highly significant psychosocial risk factor is anxiety. Prevalence estimates of anxiety disorders in patients with CAD range from 10% to 65%, with panic disorder (PD) and generalized anxiety disorder (GAD) being the most prevalent. Both PD and GAD have been independently associated with a 36% to 94% increase in the risk of adverse cardiac events in patients with CAD. However, these findings remain controversial as some studies reported either an inverse or no association between PD and adverse events. Still, both PD and GAD are associated with the presence of multiple risk factors for CAD (e.g. smoking, high alcohol consumption and a sedentary lifestyle). These anxiety disorders are also likely to influence medication taking behaviors as well as adherence to cardiac rehabilitation programs. These data highlight the importance and prognostic significance of PD/GAD in patients with CAD. However, considering the contradictory data and significant methodological issues in the available studies, notably in terms of the validity of PD and GAD diagnoses, new, methodologically sound studies are needed to improve our understanding of this clinical problem and improve patient care.
The primary aim of this study is to establish the prevalence and incidence of PD and GAD in the two years following a revascularization procedure for CAD. The secondary aim is to prospectively assess the association between these disorders and cardiac mortality, adverse cardiac events, adherence to recommended treatments (exercise, cardiac rehabilitation, pharmacotherapy),quality of life and psychological distress.
This prospective cohort study will include 3610 patients who will be consecutively recruited following a revascularisation procedure for CAD at the cardiology department of the Quebec Heart and Lung Institute. Patients will be assessed at baseline (within a week of admission) as well as 3, 6, 12 and 24 months later. PD and GAD will be assessed with a standardized and validated semi-structured interview. The presence of adverse events, adherence to treatments, psychological distress and quality of life will be assessed through a review of medical records, questionnaires and interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients who write and speak French and who have undergone a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting) for CAD.
Key inclusion criteria (1 listed)
- All adult patients (18 years of age or older) who undergo a revascularization procedure for CAD at the Quebec Heart and Lung Institute and who write/speak French will be eligible for study participation.
Key exclusion criteria (1 listed)
- Patients will be excluded if they present a severe communication problem or suffer from a terminal illness, a diagnosed major cognitive deficit, or any other condition that could invalidate the interview (e.g. psychotic disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety and Related Disorders Interview Schedule for DSM-5
Time frame: 2 years
Panic disorder (PD) and generalized anxiety disorder (GAD) will be assessed at each time point using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). This standardized interview protocol is one of the recommended measures for diagnosing anxiety disorders, including PD and GAD, in the research context. The PD and GAD modules of previous versions of the ADIS have demonstrated excellent reliability for their respective diagnoses.
Adverse cardiac events
Time frame: 2 years
Patients will be asked about all potential adverse events during a structured medical interview developed by our team. All data will be confirmed by a review of medical records. With written permission from patients or next of kin (if deceased), records for admissions or consultations outside of the study hospitals will be obtained from the establishment archives. Medical data will be extracted by the research nurses using a standardized medical data extraction form known for its excellent reliability. Adverse events are defined as: either an acute myocardial infarction, a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting), a cardiac arrest (including ventricular fibrillation) or death from a cardiovascular cause (primary cause).
11 secondary outcomes
Medical Outcomes Study Measures of Patient Adherence
Time frame: 2 years
Adherence Scale in Chronic Diseases
Time frame: 2 years
Cardiac rehabilitation participation
Time frame: 2 years
Health behaviors - Level of physical activity
Time frame: 2 years
Health behaviors - Smoking status
Time frame: 2 years
Health behaviors - Alcohol use
Time frame: 2 years
Health behaviors - Fruit and vegetable intake
Time frame: 2 years
Quality of life and psychological distress - Health-related quality of life
Time frame: 2 years
Quality of life and psychological distress - Anxiety and depressive symptoms
Time frame: 2 years
Quality of life and psychological distress - Heart- focused anxiety
Time frame: 2 years
PTSD Checklist for DSM-5
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- 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.
Guillaume Foldes-Busque, Ph.D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder and Generalized Anxiety Disorder, run by Laval University at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. 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 Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Lebel, M.A ((418)656-2131 ext. 405068, jessica.lebel@psy.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Related Disorders Interview Schedule for DSM-5 (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2020.