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临床试验/NCT07070180
NCT07070180已完成不适用

Analysis of Psychoneuroimmunological Parameters of Health in Specific Population Groups in Slovakia

Comenius University3 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
试验地点
3
主要终点
The primary outcome measure is the correlation between psychological immunity, current health status and cytokine levels as indicators of biological immune function.

研究概览

简要总结

This study aims to investigate the links between psychological and biological immunity from the perspective of psychology, epidemiology, and immunology in a general population study sample as well as in a specific group of people in treatment for alcohol addiction.

详细描述

The study will explore the associations between the level of psychological immunity and the current psychological state of the participants, possible links between the level of psychological immunity in adulthood and adverse childhood experiences, and finally, the association between the psychological immunity and biological immunity expressed by the self- assessed perceived immune status and on a molecular level by quantity of cytokines and in a specific subgroup also by natural killer cells. All this will be studied in a sample of general population as well as in a specific group of people in treatment for alcohol addiction that was chosen based on the known adverse immune-related health effects of excessive alcohol consumption.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for 'General Slovak Population Sample':
  • •Age between 18 - 50 years
  • •Residency in the respective region for at least five years
  • •Consent to participate in the study

排除标准

  • •for 'General Slovak Population Sample':
  • •Individuals younger than 18 or older than 50 years
  • •Ongoing acute infectious disease on the day of testing
  • •Eligible individuals who do not provide informed consent
  • •Inclusion Criteria for the sample 'Individuals receiving inpatient treatment for alcohol addiction at the treatment facility':
  • •Age between 18 - 50 years
  • •Admission to treatment for alcohol addiction
  • •Consent to participate in the study, Treatment completion
  • •Exclusion Criteria for the sample 'Individuals receiving inpatient treatment for alcohol addiction at the treatment facility':
  • •Individuals younger than 18 or older than 50 years
  • •Eligible individuals who do not provide informed consent
  • •Drop-out from alcohol addiction treatment

研究组 & 干预措施

General Slovak population sample

Adults aged 18 to 50, with the upper age limit set to account for the natural decline in immune function beyond this age. A total of 600 participants were recruited from three regions: 300 from the Bratislava region, 150 from the Banská Bystrica region, and 150 from the Košice region.

Individuals receiving inpatient treatment for alcohol addiction at the treatment facility

100 participants aged 18 to 50 years who undergo psychological, epidemiological, and immunological assessments multiple time points - upon admission, during hospitalisation, and at the conclusion of treatment.

结局指标

主要结局

The primary outcome measure is the correlation between psychological immunity, current health status and cytokine levels as indicators of biological immune function.

时间窗: At the time of study enrollment for Group 1, at the time of admission in treatment and after completion of 3 months of treatment for Group 2

The psychological instrument will consist of the Psychological immune competence inventory (PICI) to assess the psychological immunity. Current health status will be assessed by the epidemiological instrument that will evaluate self-assessed immune status, overall, mental, and physical health, current long-term conditions, social, and economic status. Units of measure for the questionnaires is a score. Cytokine secretion by immune cells will be tested using Bio-Plex ProTM Human Cytokine 17- plex assay according to the instructions of the manufacturer. For the analysis the blood plasma will be used. In each sample the following panel of cytokines will be analysed: G- CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β, TNF-α. Cytokine units of measure are picograms per milliliter.

次要结局

未报告次要终点

研究者

发起方
Comenius University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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