MI-SPRINT (Myocardial Infarction - Stress PRevention INTervention): A Randomized Controlled Minimal Early Behavioral Intervention Trial to Reduce the Development of ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2013-2015

ABSTRACT

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. More... »

URL

https://clinicaltrials.gov/show/NCT01781247

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3177", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3468", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "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.\n\nDetailed Description\nBackground 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.", 
    "endDate": "2015-12-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT01781247", 
    "keywords": [
      "SPRINT", 
      "myocardial infarction", 
      "prevention intervention", 
      "behavioral intervention", 
      "Reduce", 
      "development", 
      "posttraumatic stress", 
      "acute myocardial infarction", 
      "Post-Traumatic Stress Disorder", 
      "mental disorder", 
      "someone", 
      "traumatic event", 
      "patient", 
      "impaired quality", 
      "life", 
      "economic burden", 
      "society", 
      "prognosis", 
      "prevention", 
      "high relevance", 
      "guideline", 
      "early intervention", 
      "different type", 
      "Wound and Injury", 
      "overarching aim", 
      "high risk", 
      "setting", 
      "coronary care unit", 
      "primary hypothesis", 
      "intervention group", 
      "control group", 
      "intervention", 
      "secondary hypothesis", 
      "biomarker profile", 
      "control", 
      "psychosocial variable", 
      "distress", 
      "risk factor", 
      "aftermath", 
      "endothelial dysfunction", 
      "dyslipidemia", 
      "inflammation", 
      "coagulation", 
      "recent systematic review", 
      "meta-analysis", 
      "randomized controlled trial", 
      "psychological intervention", 
      "symptom", 
      "benefit", 
      "symptomatic individual", 
      "planned project", 
      "myocardial infarction patient", 
      "primary aim", 
      "counseling session", 
      "relevant level", 
      "secondary aim", 
      "cardiometabolic risk", 
      "general information", 
      "psychological stress", 
      "Coronary Disease", 
      "session", 
      "therapist", 
      "circulatory", 
      "study material", 
      "variable", 
      "sociodemographic factor", 
      "biomarker", 
      "Biological Marker"
    ], 
    "name": "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", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT01781247"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:24", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00013.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.425888.b", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.411656.1", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.7400.3", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.5734.5", 
        "type": "Organization"
      }
    ], 
    "startDate": "2013-01-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1016/j.jjcc.2011.02.007", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1006716739"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1745-6215-14-329", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031224217", 
          "https://doi.org/10.1186/1745-6215-14-329"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/archpsyc.60.10.1024", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051085817"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1371/journal.pone.0038915", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051228830"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/01.hjr.0000214606.60995.46", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1060330198"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1176/appi.ajp.2008.08040590", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1063498279"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT01781247"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT01781247'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT01781247'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT01781247'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT01781247'


 

This table displays all metadata directly associated to this object as RDF triples.

118 TRIPLES      16 PREDICATES      94 URIs      77 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT01781247 schema:about anzsrc-for:3053
2 anzsrc-for:3177
3 anzsrc-for:3468
4 schema:description 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.
5 schema:endDate 2015-12-01T00:00:00Z
6 schema:keywords Biological Marker
7 Coronary Disease
8 Post-Traumatic Stress Disorder
9 Reduce
10 SPRINT
11 Wound and Injury
12 acute myocardial infarction
13 aftermath
14 behavioral intervention
15 benefit
16 biomarker
17 biomarker profile
18 cardiometabolic risk
19 circulatory
20 coagulation
21 control
22 control group
23 coronary care unit
24 counseling session
25 development
26 different type
27 distress
28 dyslipidemia
29 early intervention
30 economic burden
31 endothelial dysfunction
32 general information
33 guideline
34 high relevance
35 high risk
36 impaired quality
37 inflammation
38 intervention
39 intervention group
40 life
41 mental disorder
42 meta-analysis
43 myocardial infarction
44 myocardial infarction patient
45 overarching aim
46 patient
47 planned project
48 posttraumatic stress
49 prevention
50 prevention intervention
51 primary aim
52 primary hypothesis
53 prognosis
54 psychological intervention
55 psychological stress
56 psychosocial variable
57 randomized controlled trial
58 recent systematic review
59 relevant level
60 risk factor
61 secondary aim
62 secondary hypothesis
63 session
64 setting
65 society
66 sociodemographic factor
67 someone
68 study material
69 symptom
70 symptomatic individual
71 therapist
72 traumatic event
73 variable
74 schema:name 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
75 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT01781247
76 schema:sdDatePublished 2019-03-07T15:24
77 schema:sdLicense https://scigraph.springernature.com/explorer/license/
78 schema:sdPublisher N8d0e7c3b5bad4d8a8d82b0e83db4f525
79 schema:sponsor https://www.grid.ac/institutes/grid.411656.1
80 https://www.grid.ac/institutes/grid.425888.b
81 https://www.grid.ac/institutes/grid.5734.5
82 https://www.grid.ac/institutes/grid.7400.3
83 schema:startDate 2013-01-01T00:00:00Z
84 schema:subjectOf sg:pub.10.1186/1745-6215-14-329
85 https://doi.org/10.1001/archpsyc.60.10.1024
86 https://doi.org/10.1016/j.jjcc.2011.02.007
87 https://doi.org/10.1097/01.hjr.0000214606.60995.46
88 https://doi.org/10.1176/appi.ajp.2008.08040590
89 https://doi.org/10.1371/journal.pone.0038915
90 schema:url https://clinicaltrials.gov/show/NCT01781247
91 sgo:license sg:explorer/license/
92 sgo:sdDataset clinical_trials
93 rdf:type schema:MedicalStudy
94 N8d0e7c3b5bad4d8a8d82b0e83db4f525 schema:name Springer Nature - SN SciGraph project
95 rdf:type schema:Organization
96 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
97 rdf:type schema:DefinedTerm
98 anzsrc-for:3177 schema:inDefinedTermSet anzsrc-for:
99 rdf:type schema:DefinedTerm
100 anzsrc-for:3468 schema:inDefinedTermSet anzsrc-for:
101 rdf:type schema:DefinedTerm
102 sg:pub.10.1186/1745-6215-14-329 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031224217
103 https://doi.org/10.1186/1745-6215-14-329
104 rdf:type schema:CreativeWork
105 https://doi.org/10.1001/archpsyc.60.10.1024 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051085817
106 rdf:type schema:CreativeWork
107 https://doi.org/10.1016/j.jjcc.2011.02.007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1006716739
108 rdf:type schema:CreativeWork
109 https://doi.org/10.1097/01.hjr.0000214606.60995.46 schema:sameAs https://app.dimensions.ai/details/publication/pub.1060330198
110 rdf:type schema:CreativeWork
111 https://doi.org/10.1176/appi.ajp.2008.08040590 schema:sameAs https://app.dimensions.ai/details/publication/pub.1063498279
112 rdf:type schema:CreativeWork
113 https://doi.org/10.1371/journal.pone.0038915 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051228830
114 rdf:type schema:CreativeWork
115 https://www.grid.ac/institutes/grid.411656.1 schema:Organization
116 https://www.grid.ac/institutes/grid.425888.b schema:Organization
117 https://www.grid.ac/institutes/grid.5734.5 schema:Organization
118 https://www.grid.ac/institutes/grid.7400.3 schema:Organization
 




Preview window. Press ESC to close (or click here)


...