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

NCT07070180 | Completed

• 1 other identifier: APVV-22-0160
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Immunity; 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; Cytokine Levels

Keywords

psychological immunity; biological immunity; psychoneuroimmunology

Outcome Measures

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.

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age between 18 - 50 years
• Residency in the respective region for at least five years
• Consent to participate in the study

You may not qualify if:

• 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
• Age between 18 - 50 years
• Admission to treatment for alcohol addiction
• Consent to participate in the study, Treatment completion
• Individuals younger than 18 or older than 50 years
• Eligible individuals who do not provide informed consent
• Drop-out from alcohol addiction treatment

Sponsors & Collaborators

• Comenius University: lead
• Slovak Academy of Sciences: collaborator

Study Sites (3)

Comenius University Bratislava, Faculty of Arts

Bratislava, 81102, Slovakia

Location

Comenius University, Faculty of Medicine in Bratislava

Bratislava, 81108, Slovakia

Location

Slovak Academy of Sciences, Institute of Neuroimmunology

Bratislava, 84510, Slovakia

Location

Related Publications (3)

• 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.

  PMID: 15337807 RESULT

• 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.

  PMID: 32492090 RESULT

• 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.

  PMID: 18835437 RESULT

Related Links

• Information about the study published on the website of Comenius Uniiversity in Slovak language

MeSH Terms

Conditions

Self-Control; Fractures, Stress; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Fractures, Bone; Wounds and Injuries; Behavioral Symptoms; Mental Disorders

Study Officials

• Alexandra Bražinová, prof., MD, PhD

  Comenius University, Faculty of Medicine in Bratislava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: July 17, 2025
• Study Start: January 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (3)