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

Post-COVID-19 Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648123
• Other study ID #: 22111301
• Status: Completed
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: April 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. What is the effect of supportive psychotherapy on the neutrophil lymphocyte ratio in post covid-19 syndrome patients?

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Medically Unexplained Symptoms
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Behavioral:
• Supportive Psychotherapy
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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pyschological and somatic symptoms	Measured with SCL-90 questionnaire. Minimum score is 0, maximum score is 360. Higher scores mean worse outcome	Change from baseline SCL-90 questionnaire at 1 week
Primary	Neutrophil Lymphocyte Ratio (NLR)	Measured by calculating the value of the ratio of neutrophils and lymphocytes based on blood sampling	Change from baseline NLR at 1 week
Primary	Heart Rate Variability	Measured by assessing SDNN by using Photoplethysmograph SA-3000P	Change from baseline SDNN at 1 week