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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Behavioral: Supportive Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dika I Sinulingga, MD; Phone Number: +62811638410; Email: dika.sinulingga@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Psychotherapy; 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	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
Active Comparator: Education; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Heart Rate Variability	Measured by assessing SDNN by using Photoplethysmograph SA-3000P	Change from baseline SDNN at 1 week

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome; Medically Unexplained Symptoms
• Other Study ID Numbers: 22111301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No