Influence of Brief Supportive Psychotherapy on Major Adve... | NCT04274205

Studies
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

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Feb 20, 2020Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Acute Coronary Syndrome
Brief Supportive Psychotherapy
Intensive Cardiac Care Unit

Interventions

Intervention group

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

Jul 30, 2019Actual

Completion Date

Jul 30, 2019Actual

First Submitted Date

Feb 14, 2020

First Submission Date that Met QC Criteria

Feb 14, 2020

First Posted Date

Feb 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intervention group	Other	Brief supportive psychotherapy	Influence of brief supportive psychotherapy Influence on brief supportive psychotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Faculty		Jakarta Pusat	DKI Jakarta	10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Intervention 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

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods