Psychosomatic DisorderNCT04868734
Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Psycho-Neuro-Endocrine Studies
A study testing Supportive Psychotherapy in people with Psychosomatic Disorder, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosomatic Disorder
- What is being tested?
- Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Apr 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Patients Psycho-Neuro-Endocrine Studies
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.
Read more
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.
Read the 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.
- Conditions
- Psychosomatic Disorder
- Being tested
- Supportive Psychotherapy
- Keywords
- Psychotherapy Supportive
- Medical subject headings
- Psychophysiologic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive PsychotherapyBehavioural
Supportive Psychotherapy give to patient with Acute Coronary Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Supportive Psychotherapy | Experimental | Supportive Psychotherapy do to subjects Receives: Behavioral: Supportive Psychotherapy |
| Casual Treatment | No intervention | Do Casual Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Serotonin level measurement (ng/dL)
Measured: 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
Cortisol level measurement (ng/dL)
Measured: 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
Immunoglobulin-A level measurement (ng/dL)
Measured: All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start7 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosomatic DisorderStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamzah Shatri, Universitas Indonesia
- Investigators
- Hamzah Shatri, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868734
- Sponsor's protocol ID
- 20-11-1478
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Superficial Supportive Psychotherapy Model and Its Effect on Acute Coronary Syndrome Patients Psycho-Neuro-Endocrine Studies
- ClinicalTrials.gov ID
- NCT04868734
- Acronym / sponsor ID
- 20-11-1478
- Conditions
- Psychosomatic Disorder
- Keywords
- Psychotherapy Supportive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Psychotherapy | Experimental | Behavioral: Supportive PsychotherapySupportive Psychotherapy do to subjects |
| Casual Treatment | No intervention | –Do Casual Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive PsychotherapySupportive Psychotherapy give to patient with Acute Coronary Syndrome | Behavioural | Supportive Psychotherapy |
Primary outcome
Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
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.
Visual Analog Scale measurement (in numeric scale from 0 to 10)
3 secondary outcomes
Changes in blood serotonin levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Time frame: 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
Time frame: 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
Time frame: All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamzah Shatri principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Psychotherapy in people with Psychosomatic Disorder, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.