Cumulative Stress and Mental Health in Young Adults

June 26, 2023 updated by: Bernadetta Izydorczyk

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland, 30-060
        • Behaviour in Crisis Lab, Impact of cumulative stress on the mental health of young people project, Jagiellonian University in Krakow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

University students participating in active learning.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
April 12, 2023 until June 15, 2023
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.
April 12, 2023 until June 15, 2023
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
April 12, 2023 until June 15, 2023
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).
April 12, 2023 until June 15, 2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Authors survey
Time Frame: April 12, 2023 until June 15, 2023
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bernadetta Izydorczyk

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jagiellonian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernadetta Izydorczyk, Prof, Institute of Psychology, Jagiellonian University in Krakow, 30-060 Krakow, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 221.0042.26_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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