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CompletedNCT04274205SupportiveUpdated Feb 20, 2020

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

An interventional study of Intervention group in Acute Coronary Syndrome, Brief Supportive Psychotherapy and Intensive Cardiac Care Unit, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Apr 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 72 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • stroke
  • cardiogenic shock at admission time
  • psychosis
  • reject to involve in study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Influence on brief supportive psychotherapy

    Intervention group

    Other: Intervention group

  • Active comparator
    Influence of brief supportive psychotherapy

    Control group

    Other: Intervention group

Interventions

  • OtherIntervention group

    Brief supportive psychotherapy

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular events

    Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death

    Time frame: 5 days

Secondary outcomes

  1. Neutrophil-lymphocytes ratio

    Pre-post measure

    Time frame: 5 days

  2. Psychological symptoms (Hospital anxiety depression scale)

    Pre-post measure

    Time frame: 5 days

07

Study locations

1 site
  • Medical Faculty
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04274205
Lead sponsor
Indonesia University
Responsible party
Hamzah Shatri (Head of Psychosomatic Division, Indonesia University) — Principal investigator
First posted
Feb 18, 2020
Start date
Apr 18, 2019
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019
Last update
Feb 20, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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