Myocardial Infarction - Stress Prevention Intervention

Study Overview
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Brief Summary
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Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality of life, social functioning, and high economic burden to the society. Posttraumatic stress attributable to MI has also been shown to be predictive of poor cardiovascular prognosis, whereby this link might relate to several atherothrombotic processes. Therefore the prevention of PTSD after MI is of high relevance. Guidelines have been published for early interventions to prevent the development of posttraumatic stress after different types of trauma but not in terms of acute MI as a traumatic event. The overarching aim of the planned trial is to test whether a minimal behavioral intervention performed shortly after acute MI in patients at a high risk to develop PTSD and in the setting of a coronary care unit reduces the development of posttraumatic stress. The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be at least 20% lower in the intervention group than in the control group, and that this effect will last up to 12 months after the intervention. The secondary hypothesis is that the intervention group will show better psychosocial functioning, and a more favourable cardiometabolic biomarker profile than the control group 3 and 12 month after the intervention.

Detailed Description
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Background Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the traumatic experience of myocardial infarction (MI). Sociodemographic and psychosocial variables, including perceived distress during MI, have been identified as risk factors for the development of posttraumatic stress in the aftermath of MI. PTSD is associated with impaired quality of life, social functioning, and high economic burden to the society. Posttraumatic stress attributable to MI has also been shown to be predictive of poor cardiovascular prognosis, whereby this link might relate to atherothrombotic processes like endothelial dysfunction, dyslipidemia, inflammation, and coagulation. Therefore the prevention of PTSD after MI is of high relevance. Guidelines have been published for early interventions to prevent the development of posttraumatic stress after different types of trauma. A recent systematic review and meta-analysis on randomized controlled trials of early psychological interventions designed to prevent symptoms of PTSD found a benefit, but only if treatment was provided to symptomatic individuals and trauma-focused. The impact of such an intervention on posttraumatic stress in response to a myocardial infarction has not been assessed so far. The planned project is the first to test, if the development of posttraumatic stress can successfully be prevented in MI patients at high risk to develop PTSD through a minimal behavioral intervention that is feasible. Objective Primary aim: The overarching aim of the planned project is to investigate in a randomized-controlled trial whether a minimal (single counseling session of 45 minutes plus an information booklet) and early-on (within 48 hours after myocardial infarction) administered behavioral intervention reduces the development of clinician-rated posttraumatic stress levels attributable to MI in patients at a high risk to develop clinically relevant levels of posttraumatic stress. Secondary aim: A further aim is to investigate whether the behavioral intervention improves psychosocial functioning and favorably affects cardiometabolic risk markers. Methods Patients considered to be at high risk to develop posttraumatic stress will be randomized to one single counseling session of 45 minutes (either targeting specific MI-triggered traumatic reactions or more general information about the role of psychological stress in coronary heart disease). The session will be performed by the study therapist in the coronary care unit within 48 hours after the patient has reached stable circulatory condition. Each patient will additionally receive written study material in the form of an information booklet. Medical variables, sociodemographic factors and cardiometabolic biomarkers will also be determined. At 3-month and 12-month follow-up each patient will be assessed for interviewer-rated posttraumatic stress levels, psychosocial functioning, and biomarkers.

Official Title
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MI-SPRINT (Myocardial Infarction - Stress PRevention INTervention): A Randomized Controlled Minimal Early Behavioral Intervention Trial to Reduce the Development of Posttraumatic Stress Caused by Acute Myocardial Infarction

Conditions
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Stress Disorders, Post-Traumatic, Myocardial Infarction

Intervention / Treatment
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* Behavioral: Minimal behavioral intervention
* Behavioral: Control intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years STEMI (ST-elevated myocardial infarction) or non-STEMI Stable circulatory condition Numeric Rating Scale (NRS) (0-10): a score of at least 5 for pain (during MI) plus a score of at least 5 for fear of dying (until admission to the CCU) and/or making sorrows and feeling helpless (when being told about having MI) Written informed consent Exclusion Criteria Participating in any other randomized-controlled trial run by the Cardiology Department of the University Hospital of Bern Emergency coronary artery bypass graft surgery Comorbid serious disease likely to cause death within 1 year Current clinically severe depression Not fully oriented to the situation, person, and place Cognitive impairment according to an adapted short version of the Mini-Mental State Examination Insufficient knowledge of German language in reading and understanding Affirmation of suicidal ideation in the last two weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients in the intervention group will participate in one single counseling session of 45 minutes (the minimal behavioral intervention) that targets specific MI-triggered traumatic reactions. | Behavioral: Minimal behavioral intervention<br>* The minimal behavioral intervention consists of one single counseling session of 45 minutes that targets specific MI-triggered traumatic reactions. The focus of the intervention is an educational and resource-oriented approach targeting individual patient resources and cognitive (re)structuring.<br>|
| Active Comparator: Control group<br>Patients in the control group will participate in one single counseling session of 45 minutes (the control intervention) that targets more general information about the role of psychological stress in coronary heart disease. | Behavioral: Control intervention<br>* The control intervention consists of one single counseling session of 45 minutes that targets more general information about the role of psychological stress in coronary heart disease. Any terminology related to trauma will be completely avoided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-rated posttraumatic stress level | Measured by Clinician-Administered PTSD Scale (CAPS) (German version) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-rated posttraumatic stress level | Measured by Clinician-Administered PTSD Scale (CAPS) (German version) | 12 months | 
| Self-rated Posttraumatic Stress | Measured by Posttraumatic Diagnostic Scale (PDS) (German version); The term event will be replaced with the term heart attack to assess MI-specific posttraumatic stress. | 3 and 12 months | 
| Quality of Life | Measured by EuroQol group 5 dimension questionnaire (EQ-5D) (German version) | 3 and 12 months | 
| Depressive Symptoms | Measured by Beck Depression Inventory (BDI) (German version) | 3 and 12 months | 
| Overall psychological distress | Measured by self-rated symptom checklist-9 (SCL-9-K) (German version) | 3 and 12 months | 
| Positive and Negative Affect | Measured by 20-item Global Mood Scale (GMS) (German version) | 3 and 12 months | 
| Time duration to recurrence at previous job (incl. part-time) |  | 3 and 12 months | 
| Time duration to recurrence at household to extent at least 50% |  | 3 and 12 months | 
| Vitality status | Measured if alive or deceased (with cause of death) | 3 and 12 months | 
| Recurrent Hospitalisations | Measured: number and cause | 3 and 12 months | 
| Recurrent Doctor Visits - general practitioner as well as specialist | Measured: number and cause | 3 and 12 months | 
| Inflammation Markers | Measured by high sensitive C-reactive protein, Interleukin-6, Tumor necrosis factor alpha, Interleukin-4 | 3 and 12 months | 
| Hemostasis Markers | Measured by Fibrinogen, D-dimer, von Willebrand factor (antigen) | 3 and 12 months | 
| Metabolic Factors | Measured by total cholesterol, Low-density lipoprotein-Cholesterol, High-density lipoprotein-Cholesterol, triglycerides, glucose, HbA1c | 3 and 12 months | 
| Anthropometric measurements | Measured by weight, height, body mass index (kg/m2), waist circumference, hip circumference, waist-to-hip ratio | 3 and 12 months | 
| Resting hemodynamics | Measured by heart rate, systolic blood pressure, diastolic blood pressure | 3 and 12 months | 
| Heart rate variability | Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio | 3 and 12 months | 
| Stress Hormones | Measured by plasma cortisol, norepinephrine, epinephrine | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Disorders, Post-Traumatic, Myocardial Infarction, Psychotherapy, Preventive Therapy, Cardiovascular Diseases, Psychological Stress, Biomarkers, Randomized Controlled Trial