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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Clinician-rated posttraumatic stress level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Intervention group
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.
干预措施: Minimal behavioral intervention (Behavioral)
Control group
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.
干预措施: Control intervention (Behavioral)
结局指标
主要结局
Clinician-rated posttraumatic stress level
时间窗: 3 months
Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
次要结局
- Recurrent Hospitalisations(3 and 12 months)
- Vitality status(3 and 12 months)
- Inflammation Markers(3 and 12 months)
- Self-rated Posttraumatic Stress(3 and 12 months)
- Recurrent Doctor Visits - general practitioner as well as specialist(3 and 12 months)
- Time duration to recurrence at previous job (incl. part-time)(3 and 12 months)
- Quality of Life(3 and 12 months)
- Time duration to recurrence at household to extent at least 50%(3 and 12 months)
- Anthropometric measurements(3 and 12 months)
- Resting hemodynamics(3 and 12 months)
- Clinician-rated posttraumatic stress level(12 months)
- Depressive Symptoms(3 and 12 months)
- Overall psychological distress(3 and 12 months)
- Positive and Negative Affect(3 and 12 months)
- Hemostasis Markers(3 and 12 months)
- Heart rate variability(3 and 12 months)
- Stress Hormones(3 and 12 months)
- Metabolic Factors(3 and 12 months)