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

NCT05648123 | Completed

• 1 other identifier: 22111301
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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. 1.What is the effect of supportive psychotherapy on psychological and somatic symptoms in post covid-19 syndrome patients?
2. 2.What is the effect of supportive psychotherapy on the neutrophil lymphocyte ratio in post covid-19 syndrome patients?
3. 3.What is the effect of supportive psychotherapy on heart rate variability in post covid-19 syndrome patients?

Conditions

Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Supportive Psychotherapy

EXPERIMENTAL

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

Education

ACTIVE COMPARATOR

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

Interventions

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

Education; Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychosis
• Can not access internet for psychotherapy
• Not willing to take part in the research

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 13, 2022
• Study Start: December 21, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

ID (1)