search
Back to results

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

Primary Purpose

Psychosomatic Disorder

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Supportive Psychotherapy
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychosomatic Disorder focused on measuring Psychotherapy Supportive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Psychotic disorders (with delusions or psychosis)
  3. Not willing to take part in research

Sites / Locations

  • dr Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supportive Psychotherapy

Casual Treatment

Arm Description

Supportive Psychotherapy do to subjects

Do Casual Intervention

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in blood serotonin levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Serotonin level measurement (ng/dL)
Changes in saliva cortisol levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Cortisol level measurement (ng/dL)
Changes in saliva immunoglobulin-A levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Immunoglobulin-A level measurement (ng/dL)

Full Information

First Posted
April 20, 2021
Last Updated
March 12, 2022
Sponsor
Indonesia University
search

1. Study Identification

Unique Protocol Identification Number
NCT04868734
Brief Title
Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Psycho-Neuro-Endocrine Studies
Official Title
Development of a Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Patients Psycho-Neuro-Endocrine Studies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypothesis The supportive psychotherapy model can be structured and developed for the non-pharmacologic therapy of acute coroner syndrome patients in intensive cardiac care unit 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. 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, 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. Psychosomatic improvements, namely anxiety, depression, and cardiac complications associated with levels of serotonin, cortisol, immunoglobulin-A and heart rate variability. Research objectives 1.1 General Objectives: To develop non-pharmacologic psychotherapy as part of holistic therapy for acute coronary syndrome patients during their treatment at intensive cardiac care unit. 1.2 Specific Objectives: Develop a structured supportive psychotherapy model 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. 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 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. 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.
Detailed Description
Introduction Acute coronary syndrome will have a high impact on who feels it. Psycho-neuro-immunological imbalance will occur before and after the attack. To date, there is no evidence regarding the role of supportive psychotherapy as a non-medical treatment in acute coronary syndromes. The study will also measure cortisol, immunoglobulin-A, serotonin, and heart rate variability for objective comparisons between intervention and usual cardiac care. Method This research is an operational research with a mixed method research design, namely exploratory sequential method with qualitative method research that precedes quantitative methods. This research is divided into two stages, namely the qualitative research stage by developing a model of supportive psychotherapy, followed by the stage of applying the model to clinical trials of acute coronary syndrome patients during treatment at intensive cardiac care unit. Result Total subject is 80 subject. All will collect blood and saliva sample, heart rate variability. One arm will do intervention (supportive psychotherapy) and the others will do usual cardiac care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosomatic Disorder
Keywords
Psychotherapy Supportive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Psychotherapy
Arm Type
Experimental
Arm Description
Supportive Psychotherapy do to subjects
Arm Title
Casual Treatment
Arm Type
No Intervention
Arm Description
Do Casual Intervention
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
Supportive Psychotherapy give to patient with Acute Coronary Syndrome
Primary Outcome Measure Information:
Title
Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Description
Visual Analog Scale measurement (in numeric scale from 0 to 10)
Time Frame
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 Outcome Measure Information:
Title
Changes in blood serotonin levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Description
Serotonin level measurement (ng/dL)
Time Frame
All subject will completed about 12 days. The blood sample will check at day 1, day 5, and day 12.
Title
Changes in saliva cortisol levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Description
Cortisol level measurement (ng/dL)
Time Frame
All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.
Title
Changes in saliva immunoglobulin-A levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Description
Immunoglobulin-A level measurement (ng/dL)
Time Frame
All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamzah Shatri
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr Cipto Mangunkusumo Hospital
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs