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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04868734
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychosomatic Disorder	Behavioral: Supportive Psychotherapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Development of a Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Patients Psycho-Neuro-Endocrine Studies
• Actual Study Start Date: Apr 7, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive Psychotherapy Supportive Psychotherapy do to subjects	Behavioral: Supportive Psychotherapy; Supportive Psychotherapy give to patient with Acute Coronary Syndrome
No Intervention: Casual Treatment Do Casual Intervention

Outcome Measures

Primary Outcome Measures

1. Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients [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.]

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

Secondary Outcome Measures

1. 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.]

   Serotonin level measurement (ng/dL)

2. 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.]

   Cortisol level measurement (ng/dL)

3. 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.]

   Immunoglobulin-A level measurement (ng/dL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	dr Cipto Mangunkusumo Hospital	Jakarta		Indonesia

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Hamzah Shatri, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamzah Shatri, Principle Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT04868734
• Other Study ID Numbers: 20-11-1478
• First Posted: May 3, 2021
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hamzah Shatri, Principle Investigator, Indonesia University: Psychotherapy Supportive
• Additional relevant MeSH terms: Acute Coronary Syndrome; Psychophysiologic Disorders; Somatoform Disorders

Study Results

No Results Posted as of Mar 15, 2022