Myocardial Infarction - Stress Prevention Intervention

NCT01781247 | Terminated DMC

• 3 other identifiers: 170/121409602258
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Clinician-rated posttraumatic stress level

  Measured by Clinician-Administered PTSD Scale (CAPS) (German version)

  3 months

Secondary Outcomes (18)

• Clinician-rated posttraumatic stress level

  12 months

• Self-rated Posttraumatic Stress

  3 and 12 months

• Quality of Life

  3 and 12 months

• Depressive Symptoms

  3 and 12 months

• Overall psychological distress

  3 and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Minimal behavioral intervention

Control group

ACTIVE COMPARATOR

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.

Behavioral: Control intervention

Interventions

Minimal behavioral intervention BEHAVIORAL

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.

Intervention group

Control intervention BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator
• University of Bern: collaborator
• University of Zurich: collaborator

Study Sites (1)

Dep. of General Internal Medicine, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (10)

• Gander ML, von Kanel R. Myocardial infarction and post-traumatic stress disorder: frequency, outcome, and atherosclerotic mechanisms. Eur J Cardiovasc Prev Rehabil. 2006 Apr;13(2):165-72. doi: 10.1097/01.hjr.0000214606.60995.46.

  PMID: 16575268 BACKGROUND

• 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.

  PMID: 22745687 BACKGROUND

• von Kanel R, Hari R, Schmid JP, Wiedemar L, Guler E, Barth J, Saner H, Schnyder U, Begre 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.

  PMID: 21493042 BACKGROUND

• 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.

  PMID: 19188285 BACKGROUND

• 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. doi: 10.1001/archpsyc.60.10.1024.

  PMID: 14557148 BACKGROUND

• 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.

  PMID: 35498017 DERIVED

• 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.

  PMID: 33580657 DERIVED

• 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.

  PMID: 33432839 DERIVED

• 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.

  PMID: 30463526 DERIVED

• 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.

  PMID: 24119487 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Myocardial Infarction; Cardiovascular Diseases; Stress, Psychological

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavioral Symptoms; Behavior

Study Officials

• Roland von Känel, Prof. Dr. med.

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

CH (1)