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Myocardial Infarction - Stress Prevention Intervention (MI-SPRINT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
Swiss National Science Foundation
University of Bern
University of Zurich
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01781247
First received: January 21, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Myocardial Infarction
Behavioral: Minimal behavioral intervention
Behavioral: Control intervention

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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Clinician-rated posttraumatic stress level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured by Clinician-Administered PTSD Scale (CAPS) (German version)


Secondary Outcome Measures:
  • Clinician-rated posttraumatic stress level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by Clinician-Administered PTSD Scale (CAPS) (German version)

  • Self-rated Posttraumatic Stress [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by EuroQol group 5 dimension questionnaire (EQ-5D) (German version)

  • Depressive Symptoms [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by Beck Depression Inventory (BDI) (German version)

  • Overall psychological distress [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by self-rated symptom checklist-9 (SCL-9-K) (German version)

  • Positive and Negative Affect [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by 20-item Global Mood Scale (GMS) (German version)

  • Time duration to recurrence at previous job (incl. part-time) [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Time duration to recurrence at household to extent at least 50% [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Vitality status [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured if alive or deceased (with cause of death)

  • Recurrent Hospitalisations [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured: number and cause

  • Recurrent Doctor Visits - general practitioner as well as specialist [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured: number and cause

  • Inflammation Markers [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by high sensitive C-reactive protein, Interleukin-6, Tumor necrosis factor alpha, Interleukin-4

  • Hemostasis Markers [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by Fibrinogen, D-dimer, von Willebrand factor (antigen)

  • Metabolic Factors [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by total cholesterol, Low-density lipoprotein-Cholesterol, High-density lipoprotein-Cholesterol, triglycerides, glucose, HbA1c

  • Anthropometric measurements [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by weight, height, body mass index (kg/m2), waist circumference, hip circumference, waist-to-hip ratio

  • Resting hemodynamics [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by heart rate, systolic blood pressure, diastolic blood pressure

  • Heart rate variability [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio

  • Stress Hormones [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Measured by plasma cortisol, norepinephrine, epinephrine


Estimated Enrollment: 426
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Patients in the intervention group will participate in one single counseling session of 45 minutes that targets specific MI-triggered traumatic reactions.
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.
Active Comparator: Control group
Patients in the control group will participate in one single counseling session of 45 minutes that targets more general information about the role of psychological stress in coronary heart disease.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781247

Contacts
Contact: Roland von Känel, Prof. Dr. med. ++41 31 632 20 19 Roland.vonKaenel@insel.ch

Locations
Switzerland
Dep. of General Internal Medicine, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Roland von Känel, Prof. Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
University of Bern
University of Zurich
Investigators
Principal Investigator: Roland von Känel, Prof. Dr. med.
Study Chair: Jean-Paul Schmid, PD Dr. med.
Study Chair: Ulrich Schnyder, Prof. Dr. med.
Study Chair: Hansjörg Znoj, Prof. Dr. phil.
Study Chair: Jürgen Barth, PD Dr. phil.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01781247     History of Changes
Other Study ID Numbers: 170/12, 140960, 2258
Study First Received: January 21, 2013
Last Updated: September 2, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Stress Disorders, Post-Traumatic
Myocardial Infarction
Psychotherapy
Preventive Therapy
Randomized Controlled Trial
Cardiovascular Diseases
Psychological Stress
Biomarkers

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Cardiovascular Diseases
Heart Diseases
Ischemia
Mental Disorders
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014