Stress, PsychologicalNCT05930652
Cumulative Stress and Mental Health in Young Adults
An observational study of Stress, Psychological and Stress-related Problem, run by Bernadetta Izydorczyk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress-related Problem, Cumulative Trauma
- What is being tested?
- Psychological tests and psychosocial questionnaires
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 12 Apr 2023to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University students participating in active learning.
Who may be able to join
- Age between 19 and 25 years
- Standard educational opportunities
- Attending the university course cycle
Who cannot join
- Age below 19
- Intellectual disability
- Inability to self-complete the research questionnaires
Trial locations and contacts
1 site in 1 country.
Poland1 site
Behaviour in Crisis Lab, Impact of cumulative stress on the mental health of young people project, Jagiellonian University in Krakow
Krakow, 30-060
About this study
Official title: Impact of Cumulative Stress on Mental Health in Young Adults
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
Read the detailed 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.
- Conditions
- Stress, Psychological, Stress-related Problem, Cumulative Trauma, Mental Health Issue, Mental Stress, Psychological Well-Being
- Being tested
- Psychological tests and psychosocial questionnaires
- Keywords
- cumulative stress, mental health, young adults, stress syndrome, risk factors, protective factors
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological tests and psychosocial questionnairesDiagnostic test
Assessment of psychological functioning (including well-being, mental health conditions, coping skills), and socio-demographics, academic performance, home, relationships, general health, habits, and attitudes.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | The population of Polish Students, who graduated from high schools/ passed leaving exams, started university studies between 2020 and 2023, and were living in Poland during this period (2020-2023: COVID-19, lockdown, economic crisis, political changes, climate changes, and the war in Ukraine). Receives: Diagnostic Test: Psychological tests and psychosocial questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 12, 2023 until June 15, 2023
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.
Measured: April 12, 2023 until June 15, 2023
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
Measured: April 12, 2023 until June 15, 2023
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).
Measured: April 12, 2023 until June 15, 2023
Secondary outcomes (1)
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)
Measured: April 12, 2023 until June 15, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Apr 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernadetta Izydorczyk
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Responsible party
- Sponsor-investigator, Bernadetta Izydorczyk, Jagiellonian University
- Investigators
- Bernadetta Izydorczyk, Prof, Principal investigator, Institute of Psychology, Jagiellonian University in Krakow, 30-060 Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930652
- Sponsor's protocol ID
- 221.0042.26_2023
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cumulative Stress on Mental Health in Young Adults
- ClinicalTrials.gov ID
- NCT05930652
- Acronym / sponsor ID
- 221.0042.26_2023
- Conditions
- Stress, Psychological, Stress-related Problem, Cumulative Trauma, Mental Health Issue, Mental Stress, Psychological Well-Being
- Keywords
- cumulative stress, mental health, young adults, stress syndrome, risk factors, protective factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Bernadetta IzydorczykUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Diagnostic Test: Psychological tests and psychosocial questionnairesThe population of Polish Students, who graduated from high schools/ passed leaving exams, started university studies between 2020 and 2023, and were living in Poland during this period (2020-2023: COVID-19, lockdown, economic crisis, political changes, climate changes, and the war in Ukraine). |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students participating in active learning.
Key inclusion criteria (3 listed)
- Age between 19 and 25 years
- Standard educational opportunities
- Attending the university course cycle
Key exclusion criteria (3 listed)
- Age below 19
- Intellectual disability
- Inability to self-complete the research questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological tests and psychosocial questionnairesAssessment of psychological functioning (including well-being, mental health conditions, coping skills), and socio-demographics, academic performance, home, relationships, general health, habits, and attitudes. | Diagnostic test | Young adults |
Primary outcome
General Well-being
Time frame: April 12, 2023 until June 15, 2023
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.
Personality Traits
Time frame: April 12, 2023 until June 15, 2023
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.
Emotion Regulation
Time frame: April 12, 2023 until June 15, 2023
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
Meaning in Life
Time frame: April 12, 2023 until June 15, 2023
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).
1 secondary outcome
Authors survey
Time frame: April 12, 2023 until June 15, 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadetta Izydorczyk, Prof principal investigator
Institute of Psychology, Jagiellonian University in Krakow, 30-060 Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Stress-related Problem, run by Bernadetta Izydorczyk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Well-being (time frame: April 12, 2023 until June 15, 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.