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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05930652
Other study ID # 221.0042.26_2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2023
Est. completion date June 15, 2023

Study information

Verified date June 2023
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about the needs of young adults - "policrisis generation", exposed to cumulative stress during 2020-2023, in terms of quality of mental health, the psychosocial resources, protective factors for cumulative stress effect, and the standards for effective prevention. The main questions to be answered are: - How does cumulative stress affect young adults? - Is there a specific cumulative stress syndrome that can be described? - What are the risk and the protective factors for cumulative stress? - How does the "policrisis generation" deal with the cumulative stress they have been exposed to? Participants will complete psychological questionnaires


Description:

Background: Epidemiological data are not sufficient to determine the mental health outcomes of exposure to cumulative stress of 2020-2023. Holistic knowledge of risk and protective factors, pathways leading to symptoms (not yet observed), and stress management strategies for the generation living under cumulative stress conditions (pandemic, war, refugee migration, economic crisis) is needed. Participants: 400 young adults, recruited among university students. Research methodology: Analysis of data collected by screening questionnaires, psychological scales, and questionnaires, related to mental health conditions.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 25 Years
Eligibility Inclusion Criteria: - Age between 19 and 25 years - Standard educational opportunities - Attending the university course cycle Exclusion Criteria: - Age below 19 - Intellectual disability - Inability to self-complete the research questionnaires

Study Design


Intervention

Diagnostic Test:
Psychological tests and psychosocial questionnaires
Assessment of psychological functioning (including well-being, mental health conditions, coping skills), and socio-demographics, academic performance, home, relationships, general health, habits, and attitudes.

Locations

Country Name City State
Poland Behaviour in Crisis Lab, Impact of cumulative stress on the mental health of young people project, Jagiellonian University in Krakow Krakow

Sponsors (2)

Lead Sponsor Collaborator
Bernadetta Izydorczyk Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary General Well-being Global Flourishing Study Questionnaire Development Report (GFS). The GFS includes 12 questions that gauge respondents' level of "flourishing" across six domains: (1) happiness and life satisfaction, (2) mental and physical health, (3) meaning and purpose, (4) character and virtue, (5) close social relationships and (6) financial and material stability. April 12, 2023 until June 15, 2023
Primary Personality Traits Personality Inventory for ICD-11 (PiCD). The four-factor structure of the Polish version of PiCD consists of three unipolar factors as Negative Affectivity, Detachment, and Dissociality factors, and one bipolar Anankastia vs. Disinhibition factor. April 12, 2023 until June 15, 2023
Primary Emotion Regulation The Difficulties in Emotion Regulation Scale (DERS). It comprises the following dimensions: (1) lack of acceptance of emotional responses, (2) difficulties in realizing goal-directed behaviors, (3) difficulties in controlling impulses, (4) lack of emotional awareness, (5) limited access to emotion regulation strategies, (6) lack of emotional clarity April 12, 2023 until June 15, 2023
Primary Meaning in Life Meaning in Life Questionnaire (MLQ). A 10-item questionnaire designed to measure two dimensions of meaning in life: (1) Presence of Meaning (how much respondents feel their lives have meaning), and (2) Search for Meaning (how much respondents strive to find meaning and understanding in their lives). April 12, 2023 until June 15, 2023
Secondary Authors survey Survey of socio-demographic data (gender, age, sexual orientation, marital status, family, relationships, socio-economic status, place of residence, educational level, habits, attitudes, others) April 12, 2023 until June 15, 2023
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