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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

Primary Purpose

Post-COVID-19 Syndrome

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 treatment trial for Post-COVID-19 Syndrome

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: Psychosis Can not access internet for psychotherapy Not willing to take part in the research

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supportive Psychotherapy

Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pyschological and somatic symptoms
Measured with SCL-90 questionnaire. Minimum score is 0, maximum score is 360. Higher scores mean worse outcome
Neutrophil Lymphocyte Ratio (NLR)
Measured by calculating the value of the ratio of neutrophils and lymphocytes based on blood sampling
Heart Rate Variability
Measured by assessing SDNN by using Photoplethysmograph SA-3000P

Secondary Outcome Measures

Full Information

First Posted
November 30, 2022
Last Updated
April 5, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05648123
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
March 17, 2023 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Psychotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Education
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Pyschological and somatic symptoms
Description
Measured with SCL-90 questionnaire. Minimum score is 0, maximum score is 360. Higher scores mean worse outcome
Time Frame
Change from baseline SCL-90 questionnaire at 1 week
Title
Neutrophil Lymphocyte Ratio (NLR)
Description
Measured by calculating the value of the ratio of neutrophils and lymphocytes based on blood sampling
Time Frame
Change from baseline NLR at 1 week
Title
Heart Rate Variability
Description
Measured by assessing SDNN by using Photoplethysmograph SA-3000P
Time Frame
Change from baseline SDNN at 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Psychosis Can not access internet for psychotherapy Not willing to take part in the research
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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