Clinical trial NCT01781247: Myocardial Infarction - Stress Prevention Intervention
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Myocardial Infarction
Keywords: Stress Disorders, Post-Traumatic
Myocardial Infarction
Psychotherapy
Preventive Therapy
Randomized Controlled Trial
Cardiovascular Diseases
Psychological Stress
Biomarkers
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University of Bern
name: University of Zurich
First posted: 2013-01-31
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician-rated posttraumatic stress level
timeFrame: 3 months
Secondary outcomes:
measure: Clinician-rated posttraumatic stress level
timeFrame: 12 months
measure: Self-rated Posttraumatic Stress
timeFrame: 3 and 12 months
measure: Quality of Life
timeFrame: 3 and 12 months
measure: Depressive Symptoms
timeFrame: 3 and 12 months
measure: Overall psychological distress
timeFrame: 3 and 12 months
measure: Positive and Negative Affect
timeFrame: 3 and 12 months
measure: Time duration to recurrence at previous job (incl. part-time)
timeFrame: 3 and 12 months
measure: Time duration to recurrence at household to extent at least 50%
timeFrame: 3 and 12 months
measure: Vitality status
timeFrame: 3 and 12 months
measure: Recurrent Hospitalisations
timeFrame: 3 and 12 months
measure: Recurrent Doctor Visits - general practitioner as well as specialist
timeFrame: 3 and 12 months
measure: Inflammation Markers
timeFrame: 3 and 12 months
measure: Hemostasis Markers
timeFrame: 3 and 12 months
measure: Metabolic Factors
timeFrame: 3 and 12 months
measure: Anthropometric measurements
timeFrame: 3 and 12 months
measure: Resting hemodynamics
timeFrame: 3 and 12 months
measure: Heart rate variability
timeFrame: 3 and 12 months
measure: Stress Hormones
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of General Internal Medicine, Bern University Hospital
Study officials:
name: Roland von Känel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
name: Jean-Paul Schmid, PD Dr. med.
role: STUDY_CHAIR
name: Ulrich Schnyder, Prof. Dr. med.
role: STUDY_CHAIR
name: Hansjörg Znoj, Prof. Dr. phil.
role: STUDY_CHAIR
name: Jürgen Barth, PD Dr. phil.
role: STUDY_CHAIR
References:
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citation: von Kanel R, Meister-Langraf RE, Zuccarella-Hackl C, Znoj H, Pazhenkottil AP, Schmid JP, Barth J, Schnyder U, Princip M. Association Between Changes in Post-hospital Cardiac Symptoms and Changes in Acute Coronary Syndrome-Induced Symptoms of Post-traumatic Stress. Front Cardiovasc Med. 2022 Apr 14;9:852710. doi: 10.3389/fcvm.2022.852710. eCollection 2022.
citation: von Kanel R, Meister-Langraf RE, Pazhenkottil AP, Barth J, Schnyder U, Schmid JP, Znoj H, Princip M. Insomnia Symptoms and Acute Coronary Syndrome-Induced Posttraumatic Stress Symptoms: A Comprehensive Analysis of Cross-sectional and Prospective Associations. Ann Behav Med. 2021 Oct 4;55(10):1019-1030. doi: 10.1093/abm/kaaa128.
citation: von Kanel R, Schmid JP, Meister-Langraf RE, Barth J, Znoj H, Schnyder U, Princip M, Pazhenkottil AP. Pharmacotherapy in the Management of Anxiety and Pain During Acute Coronary Syndromes and the Risk of Developing Symptoms of Posttraumatic Stress Disorder. J Am Heart Assoc. 2021 Jan 19;10(2):e018762. doi: 10.1161/JAHA.120.018762. Epub 2021 Jan 12.
citation: von Kanel R, Princip M, Schmid JP, Barth J, Znoj H, Schnyder U, Meister-Langraf RE. Association of sleep problems with neuroendocrine hormones and coagulation factors in patients with acute myocardial infarction. BMC Cardiovasc Disord. 2018 Nov 21;18(1):213. doi: 10.1186/s12872-018-0947-5.
citation: Meister R, Princip M, Schmid JP, Schnyder U, Barth J, Znoj H, Herbert C, von Kanel R. Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial. Trials. 2013 Oct 11;14:329. doi: 10.1186/1745-6215-14-329.