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临床试验/NCT05648123
NCT05648123已完成不适用

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 University2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
Pyschological and somatic symptoms

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Pyschological and somatic symptoms

时间窗: 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)

时间窗: 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

时间窗: Change from baseline SDNN at 1 week

Measured by assessing SDNN by using Photoplethysmograph SA-3000P

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Dika Iyona Sinulingga, SpPD

Principal Investigator

Indonesia University

研究点 (2)

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