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OpenTrials
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NCT Number: NCT05648123

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

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.

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Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supportive psychotherapy

Behavioral

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 outcomes

  1. 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

  2. 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

  3. Heart Rate Variability

    Time frame: Change from baseline SDNN at 1 week

    Measured by assessing SDNN by using Photoplethysmograph SA-3000P

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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