Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 5:14 AM
Study NCT ID:
NCT04868734
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Psycho-Neuro-Endocrine Studies
Sponsor:
Indonesia University
Organization:
Study Overview
Official Title:
Development of a Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Patients Psycho-Neuro-Endocrine Studies
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis
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. 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. 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. 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. 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:
1. Develop a structured supportive psychotherapy model
2. 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.
3. 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
4. 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.
5. 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.
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. 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. 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. 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. 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:
1. Develop a structured supportive psychotherapy model
2. 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.
3. 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
4. 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.
5. 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: