Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
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.


Options:
A: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Psycho edcuactional support; Type: EXPERIMENTAL; Interventions: Behavioral: Psychoeducational support | Intervention Type: BEHAVIORAL; Name: Psychoeducational support; Assigned to Arm(s): Psycho edcuactional support
B: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Minimal behavioral intervention | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Control intervention | Intervention Type: BEHAVIORAL; Name: Minimal behavioral intervention; Assigned to Arm(s): Intervention group | Intervention Type: BEHAVIORAL; Name: Control intervention; Assigned to Arm(s): Control group
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Psychotherapy, Other: Usual cardiological care | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Information session, Other: Usual cardiological care | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Information session; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Usual cardiological care; Assigned to Arm(s): 1, 2
D: Arm Label: Depressed Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Psychoeducation; Treatment recommendations, Drug: Pharmacotherapy | Arm Label: Depressed Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Arm Label: Non-Depressed Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Psychoeducation; Treatment recommendations; Assigned to Arm(s): Depressed Intervention | Intervention Type: DRUG; Name: Pharmacotherapy; Assigned to Arm(s): Depressed Intervention | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Depressed Usual Care

Answer: B