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CompletedNCT07070180APNIPUpdated Feb 19, 2026

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

An observational study in Immunity, Cytokine Levels and Psychological Adaptation, sponsored by Comenius University. Completed at 3 sites in Slovakia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Comenius University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
700
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Immunity
  • Cytokine Levels
  • Psychological Adaptation
  • Resilience
  • Positive Thinking
  • Sense of Control
  • Sense of Coherence
  • Self-control
  • Problem Solving
  • Mindfulness
  • Adverse Childhood Experience
  • Psychological Distress
  • Stress
  • Stress Response
  • Depression Symptoms
  • Anxiety Symptoms
  • Socio-economic Status

Keywords

  • psychological immunity
  • biological immunity
  • psychoneuroimmunology
03

In context

Self-Control

168 studies on the registry are indexed under Self-Control; 22 are open to participants now.

This study's enrollment of 700 is above the median of 262 across 19 observational studies indexed under Self-Control.

Browse Self-Control studies →

Lead sponsor

Comenius University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

'General Slovak Population Sample' will be selected from adult population aged 18-50 years living in Bratislava, Banská Bystrica and Košice regions. Participants were recruited through media promotion of the research. The study group was selected from the registered volunteers based on stratification by age and sex, with equal representation across the age groups 18-30, 31-40, and 41-50 years.

The sample 'Individuals receiving inpatient treatment for alcohol addiction at the treatment facility' was selected from patients admitted at addiction treatment facility within 48 hours of their admission. The study sample included 100 volunteers aged 18-50 years.

Eligibility criteria

Inclusion Criteria 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

Exclusion Criteria 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 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

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Study locations

3 sites
  • Comenius University Bratislava, Faculty of Arts
    Bratislava, 81102, Slovakia
  • Comenius University, Faculty of Medicine in Bratislava
    Bratislava, 81108, Slovakia
  • Slovak Academy of Sciences, Institute of Neuroimmunology
    Bratislava, 84510, Slovakia
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References and documents

Publications

  • Andersen BL, Farrar WB, Golden-Kreutz DM, Glaser R, Emery CF, Crespin TR, Shapiro CL, Carson WE 3rd. Psychological, behavioral, and immune changes after a psychological intervention: a clinical trial. J Clin Oncol. 2004 Sep 1;22(17):3570-80. doi: 10.1200/JCO.2004.06.030. PubMed 15337807 ↗
  • Shields GS, Spahr CM, Slavich GM. Psychosocial Interventions and Immune System Function: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Psychiatry. 2020 Oct 1;77(10):1031-1043. doi: 10.1001/jamapsychiatry.2020.0431. PubMed 32492090 ↗
  • Brydon L, Walker C, Wawrzyniak A, Whitehead D, Okamura H, Yajima J, Tsuda A, Steptoe A. Synergistic effects of psychological and immune stressors on inflammatory cytokine and sickness responses in humans. Brain Behav Immun. 2009 Feb;23(2):217-24. doi: 10.1016/j.bbi.2008.09.007. Epub 2008 Sep 20. PubMed 18835437 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07070180
Lead sponsor
Comenius University
Collaborators
Slovak Academy of Sciences
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Jan 1, 2024
Primary completion
Dec 15, 2024
Completion
Dec 15, 2025
Last update
Feb 19, 2026

Study contacts

Alexandra Bražinová, prof., MD, PhD
principal investigator · Comenius University, Faculty of Medicine in Bratislava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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