Myocardial Infarction - Stress Prevention Intervention

Myocardial Infarction Clinical Trial

— MI-SPRINT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01781247
• Other study ID #: 170/12
• Secondary ID: 1409602258
• Status: Terminated
• Phase: N/A
• First received: January 21, 2013
• Last updated: January 6, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Minimal behavioral intervention
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.
• Control intervention
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.

Locations

Country	Name	City	State
Switzerland	Dep. of General Internal Medicine, Bern University Hospital	Bern

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss National Science Foundation, University of Bern, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Edmondson D, Richardson S, Falzon L, Davidson KW, Mills MA, Neria Y. Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary syndrome patients: a meta-analytic review. PLoS One. 2012;7(6):e38915. doi: 10.1371/journal.pone.0038915. Epub 2012 Jun 20. Review. — View Citation

Ehlers A, Clark DM, Hackmann A, McManus F, Fennell M, Herbert C, Mayou R. A randomized controlled trial of cognitive therapy, a self-help booklet, and repeated assessments as early interventions for posttraumatic stress disorder. Arch Gen Psychiatry. 2003 Oct;60(10):1024-32. — View Citation

Gander ML, von Känel R. Myocardial infarction and post-traumatic stress disorder: frequency, outcome, and atherosclerotic mechanisms. Eur J Cardiovasc Prev Rehabil. 2006 Apr;13(2):165-72. Review. — View Citation

Roberts NP, Kitchiner NJ, Kenardy J, Bisson JI. Systematic review and meta-analysis of multiple-session early interventions following traumatic events. Am J Psychiatry. 2009 Mar;166(3):293-301. doi: 10.1176/appi.ajp.2008.08040590. Epub 2009 Feb 2. Review. — View Citation

von Känel R, Hari R, Schmid JP, Wiedemar L, Guler E, Barth J, Saner H, Schnyder U, Begré S. Non-fatal cardiovascular outcome in patients with posttraumatic stress symptoms caused by myocardial infarction. J Cardiol. 2011 Jul;58(1):61-8. doi: 10.1016/j.jjcc.2011.02.007. Epub 2011 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-rated posttraumatic stress level	Measured by Clinician-Administered PTSD Scale (CAPS) (German version)	3 months	No
Secondary	Clinician-rated posttraumatic stress level	Measured by Clinician-Administered PTSD Scale (CAPS) (German version)	12 months	No
Secondary	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	No
Secondary	Quality of Life	Measured by EuroQol group 5 dimension questionnaire (EQ-5D) (German version)	3 and 12 months	No
Secondary	Depressive Symptoms	Measured by Beck Depression Inventory (BDI) (German version)	3 and 12 months	No
Secondary	Overall psychological distress	Measured by self-rated symptom checklist-9 (SCL-9-K) (German version)	3 and 12 months	No
Secondary	Positive and Negative Affect	Measured by 20-item Global Mood Scale (GMS) (German version)	3 and 12 months	No
Secondary	Time duration to recurrence at previous job (incl. part-time)		3 and 12 months	No
Secondary	Time duration to recurrence at household to extent at least 50%		3 and 12 months	No
Secondary	Vitality status	Measured if alive or deceased (with cause of death)	3 and 12 months	No
Secondary	Recurrent Hospitalisations	Measured: number and cause	3 and 12 months	No
Secondary	Recurrent Doctor Visits - general practitioner as well as specialist	Measured: number and cause	3 and 12 months	No
Secondary	Inflammation Markers	Measured by high sensitive C-reactive protein, Interleukin-6, Tumor necrosis factor alpha, Interleukin-4	3 and 12 months	No
Secondary	Hemostasis Markers	Measured by Fibrinogen, D-dimer, von Willebrand factor (antigen)	3 and 12 months	No
Secondary	Metabolic Factors	Measured by total cholesterol, Low-density lipoprotein-Cholesterol, High-density lipoprotein-Cholesterol, triglycerides, glucose, HbA1c	3 and 12 months	No
Secondary	Anthropometric measurements	Measured by weight, height, body mass index (kg/m2), waist circumference, hip circumference, waist-to-hip ratio	3 and 12 months	No
Secondary	Resting hemodynamics	Measured by heart rate, systolic blood pressure, diastolic blood pressure	3 and 12 months	No
Secondary	Heart rate variability	Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio	3 and 12 months	No
Secondary	Stress Hormones	Measured by plasma cortisol, norepinephrine, epinephrine	3 and 12 months	No