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 (Supportive)

February 18, 2020 updated by: Hamzah Shatri, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Medical faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Influence on brief supportive psychotherapy
Intervention group
Other: Intervention group
Brief supportive psychotherapy
Other Names:
  • Control group
Active Comparator: Influence of brief supportive psychotherapy
Control group
Other: Intervention group
Brief supportive psychotherapy
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 5 days
Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil-lymphocytes ratio
Time Frame: 5 days
Pre-post measure
5 days
Psychological symptoms (Hospital anxiety depression scale)
Time Frame: 5 days
Pre-post measure
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET-177/UN2.F1/ETIK/PPM.00.02/

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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