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

NCT04274205 | Completed

• 1 other identifier: KET-177/UN2.F1/ETIK/PPM.00.02/
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death

  5 days

Secondary Outcomes (2)

• Neutrophil-lymphocytes ratio

  5 days

• Psychological symptoms (Hospital anxiety depression scale)

  5 days

Study Arms (2)

Influence on brief supportive psychotherapy

ACTIVE COMPARATOR

Intervention group

Other: Intervention group

Influence of brief supportive psychotherapy

ACTIVE COMPARATOR

Control group

Other: Intervention group

Interventions

Intervention group OTHER

Brief supportive psychotherapy

Also known as: Control group

Influence of brief supportive psychotherapy; Influence on brief supportive psychotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• stroke
• cardiogenic shock at admission time
• psychosis
• reject to involve in study

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Medical Faculty

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychosomatic Division

Model Details: 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

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: April 18, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)