Stress Disorders, Post-TraumaticMI-SPRINTNCT01781247
Myocardial Infarction - Stress Prevention Intervention
A study testing Minimal behavioral intervention in people with Stress Disorders, Post-Traumatic and Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Myocardial Infarction
- What is being tested?
- Minimal behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of General Internal Medicine, Bern University Hospital
Bern, Canton of Bern, 3010
About this study
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
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.
Read the 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.
- Being tested
- Minimal behavioral intervention, Control intervention
- Keywords
- Stress Disorders, Post-Traumatic, Myocardial Infarction, Psychotherapy, Preventive Therapy, Randomized Controlled Trial, Cardiovascular Diseases, Psychological Stress, Biomarkers
- Medical subject headings
- Stress Disorders, Post-Traumatic, Myocardial Infarction, Cardiovascular Diseases, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal behavioral interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-rated posttraumatic stress level
Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
Measured: 3 months
Secondary outcomes (18)
Clinician-rated posttraumatic stress level
Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
Measured: 12 months
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.
Measured: 3 and 12 months
Quality of Life
Measured by EuroQol group 5 dimension questionnaire (EQ-5D) (German version)
Measured: 3 and 12 months
Depressive Symptoms
Measured by Beck Depression Inventory (BDI) (German version)
Measured: 3 and 12 months
Overall psychological distress
Measured by self-rated symptom checklist-9 (SCL-9-K) (German version)
Measured: 3 and 12 months
Positive and Negative Affect
Measured by 20-item Global Mood Scale (GMS) (German version)
Measured: 3 and 12 months
Time duration to recurrence at previous job (incl. part-time)
Measured: 3 and 12 months
Time duration to recurrence at household to extent at least 50%
Measured: 3 and 12 months
Vitality status
Measured if alive or deceased (with cause of death)
Measured: 3 and 12 months
Recurrent Hospitalisations
Measured: number and cause
Measured: 3 and 12 months
Recurrent Doctor Visits - general practitioner as well as specialist
Measured: number and cause
Measured: 3 and 12 months
Inflammation Markers
Measured by high sensitive C-reactive protein, Interleukin-6, Tumor necrosis factor alpha, Interleukin-4
Measured: 3 and 12 months
Hemostasis Markers
Measured by Fibrinogen, D-dimer, von Willebrand factor (antigen)
Measured: 3 and 12 months
Metabolic Factors
Measured by total cholesterol, Low-density lipoprotein-Cholesterol, High-density lipoprotein-Cholesterol, triglycerides, glucose, HbA1c
Measured: 3 and 12 months
Anthropometric measurements
Measured by weight, height, body mass index (kg/m2), waist circumference, hip circumference, waist-to-hip ratio
Measured: 3 and 12 months
Resting hemodynamics
Measured by heart rate, systolic blood pressure, diastolic blood pressure
Measured: 3 and 12 months
Heart rate variability
Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio
Measured: 3 and 12 months
Stress Hormones
Measured by plasma cortisol, norepinephrine, epinephrine
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Population of eligible patients smaller than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Roland von Känel, Prof. Dr. med., Principal investigatorJean-Paul Schmid, PD Dr. med., Study chairUlrich Schnyder, Prof. Dr. med., Study chairHansjörg Znoj, Prof. Dr. phil., Study chairJürgen Barth, PD Dr. phil., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781247
- Sponsor's protocol ID
- 170/12
- Other IDs
- 140960, 2258
- Acronym
- MI-SPRINT
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2013
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16575268Edmondson 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.
PubMed 22745687von 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.
PubMed 21493042Roberts 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.
PubMed 19188285Ehlers 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.
PubMed 14557148von 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.
PubMed 35498017von 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.
PubMed 33580657von 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.
PubMed 33432839von 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.
PubMed 30463526Meister 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.
PubMed 24119487
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01781247
- Acronym / sponsor ID
- MI-SPRINT / 170/12
- Keywords
- Stress Disorders, Post-Traumatic, Myocardial Infarction, Psychotherapy, Preventive Therapy, Randomized Controlled Trial, Cardiovascular Diseases, Psychological Stress, Biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Population of eligible patients smaller than anticipated
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, University of Zurich
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Minimal behavioral interventionPatients 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. |
| Control group | Active comparator | Behavioral: Control interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal behavioral interventionThe 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. | Behavioural | Intervention group |
| Control interventionThe 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. | Behavioural | Control group |
Primary outcome
Clinician-rated posttraumatic stress level
Time frame: 3 months
Measured by Clinician-Administered PTSD Scale (CAPS) (German version)
18 secondary outcomes
Clinician-rated posttraumatic stress level
Time frame: 12 months
Self-rated Posttraumatic Stress
Time frame: 3 and 12 months
Quality of Life
Time frame: 3 and 12 months
Depressive Symptoms
Time frame: 3 and 12 months
Overall psychological distress
Time frame: 3 and 12 months
Positive and Negative Affect
Time frame: 3 and 12 months
Time duration to recurrence at previous job (incl. part-time)
Time frame: 3 and 12 months
Time duration to recurrence at household to extent at least 50%
Time frame: 3 and 12 months
Vitality status
Time frame: 3 and 12 months
Recurrent Hospitalisations
Time frame: 3 and 12 months
Recurrent Doctor Visits - general practitioner as well as specialist
Time frame: 3 and 12 months
Inflammation Markers
Time frame: 3 and 12 months
Hemostasis Markers
Time frame: 3 and 12 months
Metabolic Factors
Time frame: 3 and 12 months
Anthropometric measurements
Time frame: 3 and 12 months
Resting hemodynamics
Time frame: 3 and 12 months
Heart rate variability
Time frame: 3 and 12 months
Stress Hormones
Time frame: 3 and 12 months
Results and safety
The study was stopped early (reason given: Population of eligible patients smaller than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Background: PubMed 16575268Gander 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.
- Background: PubMed 22745687Edmondson 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.
- Background: PubMed 21493042von 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.
- Background: PubMed 19188285Roberts 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.
- Background: PubMed 14557148Ehlers 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.
- Derived from this study: PubMed 35498017von 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.
- Derived from this study: PubMed 33580657von 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.
- Derived from this study: PubMed 33432839von 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.
- Derived from this study: PubMed 30463526von 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.
- Derived from this study: PubMed 24119487Meister 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.
Related trials for Stress Disorders, Post-Traumatic
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland von Känel, Prof. Dr. med. principal investigator
Jean-Paul Schmid, PD Dr. med. study chair
Ulrich Schnyder, Prof. Dr. med. study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal behavioral intervention in people with Stress Disorders, Post-Traumatic and Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Population of eligible patients smaller than anticipated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-rated posttraumatic stress level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781247, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.