Post-COVID-19 SyndromeNCT05648123
Effectiveness of Supportive Psychotherapy Through Internet-Based Teleconsultation on Psychological and Somatic Symptoms, Neutrophil-Lymphocyte Ratio, and Heart Rate Variability in Post Covid-19 Syndrome Patients
A study testing Supportive Psychotherapy in people with Post-COVID-19 Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn about the effectiveness of supportive psychotherapy in post covid-19 syndrome patients. The main questions it aims to answer are: 1. What is the effect of supportive psychotherapy on psychological and somatic symptoms in post covid-19 syndrome patients? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- 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
- 77 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Dec 2022to 17 Mar 2023
- 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 over
- Patients confirmed positive for SARS CoV-2 by molecular testing (SARS CoV-2 RT-PCR, naso-oropharyngeal swab) at least 3 months before recruitment, with symptoms and effects lasting for at least 2 months and not explained by alternative diagnoses other
- Patients with or without comorbidities: diabetes mellitus, hypertension, tuberculosis, asthma, chronic obstructive pulmonary disease, chronic kidney disease, heart disease, chronic liver disease, malignancy, nervous system disease, patients with vulnerability, patients with disabilities.
- Patients can communicate and are willing to be interviewed, fill out questionnaires and psychotherapy.
- The patient is willing to fill out and sign an informed 1 sheet of consent to participate in the study
Who cannot join
- Psychosis
- Can not access internet for psychotherapy
- Not willing to take part in the research
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
The goal of this clinical trial is to learn about the effectiveness of supportive psychotherapy in post covid-19 syndrome patients. The main questions it aims to answer are:
- What is the effect of supportive psychotherapy on psychological and somatic symptoms in post covid-19 syndrome patients?
- What is the effect of supportive psychotherapy on the neutrophil lymphocyte ratio in post covid-19 syndrome patients?
- What is the effect of supportive psychotherapy on heart rate variability in post covid-19 syndrome patients?
Read more
Participants will be given supportive psychotherapy in the form of an online group for 3 times a week with a duration of psychotherapy ranging from 1 - 2 hours per session.
Researchers will compare the supportive psychotherapy group to education group as control. The control group will be given education about Post Covid-19 syndrome in the form of an online group for 3 times a week with a duration of around 1 - 2 hours per session.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Supportive Psychotherapy
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive PsychotherapyBehavioural
Supportive psychotherapy is a treatment that uses direct measures to ameliorate symptoms and to maintain, restore or improve self-esteem, ego function, and adaptive skills
| Study group | Role | What they receive |
|---|---|---|
| Supportive Psychotherapy | Experimental | supportive psychotherapy will be given in the form of an online group for 3 times a week with a duration of psychotherapy ranging from 1 - 2 hours per session Receives: Behavioral: Supportive Psychotherapy |
| Education | Active comparator | education about post covid-19 syndrome will be given in the form of an online group for 3 times a week with a duration about 1 - 2 hours per session Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pyschological and somatic symptoms
Measured with SCL-90 questionnaire. Minimum score is 0, maximum score is 360. Higher scores mean worse outcome
Measured: Change from baseline SCL-90 questionnaire at 1 week
Neutrophil Lymphocyte Ratio (NLR)
Measured by calculating the value of the ratio of neutrophils and lymphocytes based on blood sampling
Measured: Change from baseline NLR at 1 week
Heart Rate Variability
Measured by assessing SDNN by using Photoplethysmograph SA-3000P
Measured: Change from baseline SDNN at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start21 Dec 2022
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Dika Iyona Sinulingga, SpPD, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648123
- Sponsor's protocol ID
- 22111301
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supportive Psychotherapy Through Internet-Based Teleconsultation on Psychological and Somatic Symptoms, Neutrophil-Lymphocyte Ratio, and Heart Rate Variability in Post Covid-19 Syndrome Patients
- ClinicalTrials.gov ID
- NCT05648123
- Acronym / sponsor ID
- 22111301
- Conditions
- Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 13 Dec 2022 (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.
The goal of this clinical trial is to learn about the effectiveness of supportive psychotherapy in post covid-19 syndrome patients. The main questions it aims to answer are:
- What is the effect of supportive psychotherapy on psychological and somatic symptoms in post covid-19 syndrome patients?
- What is the effect of supportive psychotherapy on the neutrophil lymphocyte ratio in post covid-19 syndrome patients?
- What is the effect of supportive psychotherapy on heart rate variability in post covid-19 syndrome patients?
Participants will be given supportive psychotherapy in the form of an online group for 3 times a week with a duration of psychotherapy ranging from 1 - 2 hours per session.
Researchers will compare the supportive psychotherapy group to education group as control. The control group will be given education about Post Covid-19 syndrome in the form of an online group for 3 times a week with a duration of around 1 - 2 hours per session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Psychotherapy | Experimental | Behavioral: Supportive Psychotherapysupportive psychotherapy will be given in the form of an online group for 3 times a week with a duration of psychotherapy ranging from 1 - 2 hours per session |
| Education | Active comparator | Behavioral: Supportive Psychotherapyeducation about post covid-19 syndrome will be given in the form of an online group for 3 times a week with a duration about 1 - 2 hours per session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or over
- Patients confirmed positive for SARS CoV-2 by molecular testing (SARS CoV-2 RT-PCR, naso-oropharyngeal swab) at least 3 months before recruitment, with symptoms and effects lasting for at least 2 months and not explained by alternative diagnoses other
- Patients with or without comorbidities: diabetes mellitus, hypertension, tuberculosis, asthma, chronic obstructive pulmonary disease, chronic kidney disease, heart disease, chronic liver disease, malignancy, nervous system disease, patients with vulnerability, patients with disabilities.
- Patients can communicate and are willing to be interviewed, fill out questionnaires and psychotherapy.
- The patient is willing to fill out and sign an informed 1 sheet of consent to participate in the study
Key exclusion criteria (3 listed)
- Psychosis
- Can not access internet for psychotherapy
- Not willing to take part in the 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 is a treatment that uses direct measures to ameliorate symptoms and to maintain, restore or improve self-esteem, ego function, and adaptive skills | Behavioural | Education, Supportive Psychotherapy |
Primary outcome
Pyschological and somatic symptoms
Time frame: Change from baseline SCL-90 questionnaire at 1 week
Measured with SCL-90 questionnaire. Minimum score is 0, maximum score is 360. Higher scores mean worse outcome
Neutrophil Lymphocyte Ratio (NLR)
Time frame: Change from baseline NLR at 1 week
Measured by calculating the value of the ratio of neutrophils and lymphocytes based on blood sampling
Heart Rate Variability
Time frame: Change from baseline SDNN at 1 week
Measured by assessing SDNN by using Photoplethysmograph SA-3000P
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 6 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Post-COVID-19 Syndrome, 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 5 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 6 Apr 2023. 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?
Pyschological and somatic symptoms (time frame: Change from baseline SCL-90 questionnaire at 1 week). The study lists 3 primary outcomes in all. 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 6 Apr 2023.