ImmunityAPNIPNCT07070180
Analysis of Psychoneuroimmunological Parameters of Health in Specific Population Groups in Slovakia
An observational study of Immunity and Cytokine Levels, run by Comenius University at 3 sites in Slovakia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity, Cytokine Levels, Psychological Adaptation
- How many people
- 700 participants
- Where
- 3 sitesSlovakia
- Study dates
- 1 Jan 2024to 15 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age between 18 - 50 years
- Residency in the respective region for at least five years
- Consent to participate in the study
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Slovakia3 sites
Comenius University Bratislava, Faculty of Arts
Bratislava, 81102
Comenius University, Faculty of Medicine in Bratislava
Bratislava, 81108
Slovak Academy of Sciences, Institute of Neuroimmunology
Bratislava, 84510
About this study
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.
- Conditions
- Immunity, Cytokine Levels, Psychological Adaptation, Resilience, Positive Thinking, Sense of Control
- Keywords
- psychological immunity, biological immunity, psychoneuroimmunology
- Medical subject headings
- Self-Control, Fractures, Stress, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jan 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Alexandra Bražinová, prof., MD, PhD, Principal investigator, Comenius University, Faculty of Medicine in Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070180
- Sponsor's protocol ID
- APVV-22-0160
- Acronym
- APNIP
- Status last verified
- Feb 2026
- First submitted
- 18 May 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15337807Shields 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 32492090Brydon 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