Back to resultsInfluence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit (Supportive)
Primary Purpose
Acute Coronary Syndrome, Brief Supportive Psychotherapy, Intensive Cardiac Care Unit
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms
Eligibility Criteria
Inclusion Criteria:
- acute coronary syndrome
- 》 18 years old
- have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
- be able to communicate and ready to have interview, fill the questioners and psychotherapy
Exclusion Criteria:
- stroke
- cardiogenic shock at admission time
- psychosis
- reject to involve in study
Sites / Locations
- Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Influence on brief supportive psychotherapy
Influence of brief supportive psychotherapy
Arm Description
Intervention group
Control group
Outcomes
Primary Outcome Measures
Major adverse cardiovascular events
Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death
Secondary Outcome Measures
Neutrophil-lymphocytes ratio
Pre-post measure
Psychological symptoms (Hospital anxiety depression scale)
Pre-post measure
Full Information
NCT ID
NCT04274205
First Posted
February 14, 2020
Last Updated
February 18, 2020
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT04274205
Brief Title
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit
Acronym
Supportive
Official Title
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome Patients in Intensive Cardiac Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Brief Supportive Psychotherapy, Intensive Cardiac Care Unit
Keywords
Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups Acute coronary syndrome group who got brief psychotherapy in five session in 5 days.. 30 minutes in 1 session Acute coronary syndrome group who did not get brief supportive psychotherapy as control Double opened RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influence on brief supportive psychotherapy
Arm Type
Active Comparator
Arm Description
Intervention group
Arm Title
Influence of brief supportive psychotherapy
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Control group
Intervention Description
Brief supportive psychotherapy
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Neutrophil-lymphocytes ratio
Description
Pre-post measure
Time Frame
5 days
Title
Psychological symptoms (Hospital anxiety depression scale)
Description
Pre-post measure
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute coronary syndrome
》 18 years old
have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
be able to communicate and ready to have interview, fill the questioners and psychotherapy
Exclusion Criteria:
stroke
cardiogenic shock at admission time
psychosis
reject to involve in study
Facility Information:
Facility Name
Medical Faculty
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit
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