Myocardial Infarction - Stress Prevention Intervention
- Conditions
- Stress Disorders, Post-TraumaticMyocardial Infarction
- Interventions
- Behavioral: Control interventionBehavioral: Minimal behavioral intervention
- Registration Number
- NCT01781247
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 190
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control intervention 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. Intervention group Minimal behavioral intervention 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.
- Primary Outcome Measures
Name Time Method Clinician-rated posttraumatic stress level 3 months Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
- Secondary Outcome Measures
Name Time Method Vitality status 3 and 12 months Measured if alive or deceased (with cause of death)
Inflammation Markers 3 and 12 months Measured by high sensitive C-reactive protein, Interleukin-6, Tumor necrosis factor alpha, Interleukin-4
Self-rated Posttraumatic Stress 3 and 12 months 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.
Recurrent Doctor Visits - general practitioner as well as specialist 3 and 12 months Measured: number and cause
Quality of Life 3 and 12 months Measured by EuroQol group 5 dimension questionnaire (EQ-5D) (German version)
Time duration to recurrence at household to extent at least 50% 3 and 12 months Anthropometric measurements 3 and 12 months Measured by weight, height, body mass index (kg/m2), waist circumference, hip circumference, waist-to-hip ratio
Time duration to recurrence at previous job (incl. part-time) 3 and 12 months Recurrent Hospitalisations 3 and 12 months Measured: number and cause
Resting hemodynamics 3 and 12 months Measured by heart rate, systolic blood pressure, diastolic blood pressure
Clinician-rated posttraumatic stress level 12 months Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
Depressive Symptoms 3 and 12 months Measured by Beck Depression Inventory (BDI) (German version)
Overall psychological distress 3 and 12 months Measured by self-rated symptom checklist-9 (SCL-9-K) (German version)
Positive and Negative Affect 3 and 12 months Measured by 20-item Global Mood Scale (GMS) (German version)
Hemostasis Markers 3 and 12 months Measured by Fibrinogen, D-dimer, von Willebrand factor (antigen)
Heart rate variability 3 and 12 months Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio
Stress Hormones 3 and 12 months Measured by plasma cortisol, norepinephrine, epinephrine
Metabolic Factors 3 and 12 months Measured by total cholesterol, Low-density lipoprotein-Cholesterol, High-density lipoprotein-Cholesterol, triglycerides, glucose, HbA1c
Trial Locations
- Locations (1)
Dep. of General Internal Medicine, Bern University Hospital
🇨🇭Bern, Switzerland