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Clinical Trials/NCT05648123
NCT05648123
Completed
N/A

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

Indonesia University1 site in 1 country77 target enrollmentDecember 21, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-COVID-19 Syndrome
Sponsor
Indonesia University
Enrollment
77
Locations
1
Primary Endpoint
Pyschological and somatic symptoms
Status
Completed
Last Updated
3 years ago

Overview

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:

  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.

Registry
clinicaltrials.gov
Start Date
December 21, 2022
End Date
March 17, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr. Dika Iyona Sinulingga, SpPD

Principal Investigator

Indonesia University

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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