Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Psycho-Neuro-Endocrine Studies

NCT04868734 | Completed

• 1 other identifier: 20-11-1478
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis

1. 1.The supportive psychotherapy model can be structured and developed for the non-pharmacologic therapy of acute coroner syndrome patients in intensive cardiac care unit
2. 2.The development of the supportive psychotherapy model can provide an improvement in psychological function in the form of a reduction in symptoms of anxiety, depression, and an improvement in the quality of life of acute coroner syndrome patients during treatment at intensive cardiac care unit.
3. 3.Psycho-patho-mechanization of supportive psychotherapy model development in the improvement of psychosomatic function of acute coroner syndrome patients by assessing the improvement of serotonin, cortisol, and immunoglobulin-A levels, and,
4. 4.Development of the supportive psychotherapy model can provide improvement in somatic function in the form of decreased complications such as arrhythmias, pericarditis, chronic heart failure, shock and death of acute coronary syndrome patients during treatment.
5. 5.Psychosomatic improvements, namely anxiety, depression, and cardiac complications associated with levels of serotonin, cortisol, immunoglobulin-A and heart rate variability.
6. 6.Develop a structured supportive psychotherapy model
7. 7.Proving the role of supportive psychotherapy in the improvement of psychological symptoms of anxiety, depression and quality of life in acute coronary syndrome patients during treatment.
8. 8.Proving the psycho-patho-mechanism intervention of the supportive psychotherapy model in improving psychosomatic function through the Hypothalamus-Pituitary-Adrenal pathway, namely by assessing the improvement in levels of serotonin, cortisol, immunoglobulin-A and heart rate variability
9. 9.Proving the role of supportive psychotherapy in the improvement of somatic symptoms of cardiac complications such as arrhythmias, pericarditis, chronic heart failure, shock and death in acute coronary syndrome patients during treatment.
10. 10.To prove the supportive psychotherapy model in psychosomatic improvement, namely anxiety, depression, and cardiac complications associated with improvements in levels of serotonin, cortisol, immunoglobulin-A and heart rate variability.

Conditions

Psychosomatic Disorder

Keywords

Psychotherapy Supportive

Outcome Measures

Primary Outcomes (1)

• Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients

  Visual Analog Scale measurement (in numeric scale from 0 to 10)

  per subject will completed about 12 days. Supportive psychotherapy will do to intervention subject and all subject (wit and without intervention) will ask visual analog scale at day 1, day 5, and day 12.

Secondary Outcomes (3)

• Changes in blood serotonin levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients

  All subject will completed about 12 days. The blood sample will check at day 1, day 5, and day 12.

• Changes in saliva cortisol levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients

  All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.

• Changes in saliva immunoglobulin-A levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients

  All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.

Study Arms (2)

Supportive Psychotherapy

EXPERIMENTAL

Supportive Psychotherapy do to subjects

Behavioral: Supportive Psychotherapy

Casual Treatment

NO INTERVENTION

Do Casual Intervention

Interventions

Supportive Psychotherapy BEHAVIORAL

Supportive Psychotherapy give to patient with Acute Coronary Syndrome

Supportive Psychotherapy

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Patients diagnosed with ACS by cardiologists and have received standard management with or without PCI.
• The patient is willing to participate in the research

You may not qualify if:

• ACS patients who had acute complications related to ACS upon admission before the study started, such as the presence of CHF, arrhythmias, pericarditis, cardiogenic shock or death.
• Psychotic disorders (with delusions or psychosis)
• Not willing to take part in research

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

dr Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Psychophysiologic Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hamzah Shatri

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 3, 2021
• Study Start: April 7, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

ID (1)