AnxietyNCT04926441
Stress Levels and Mental Well-Being Among Students During e-Learning
An observational study of Anxiety and Depression, run by The Opole University of Technology at 8 sites in 3 countries.
Trial summary
Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Stress Levels and Mental Well-Being assessment
- How many people
- 4,870 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 15 Feb 2021to 30 Apr 2021
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students participating in active learning
Who may be able to join
- Students attending the course cycle
Who cannot join
- Inability to self-complete the research questionnaires;
- Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Slovakia4 sites
Slovak Medical University in Bratislava
Banská Bystrica, 874 05
Matej Bel University
Banská Bystrica, 974 01
Technical University of Košice
Košice, 042 00
Constantine the Philosopher University in Nitra
Nitra, 949 01
Poland3 sites
Jan Dlugosz University in Czestochowa
Częstochowa, 42-200
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
The University School of Physical Education in Wroclaw
Wroclaw, 50-254
About this study
Official title: Stress Levels and Mental Well-Being Among Polish, Slovakian and Lithuanian Students During E-learning
Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Polish, Slovak and Lithuanian Students.
Read the detailed description
The COVID-19 pandemic has had the effect of accelerating changes in educational processes around the world. It resulted in a rapid conversion from face-to-face to online classes. This has disrupted the regular pattern of education and standard practices that have been followed for many years. It is a big organizational challenge for the academics but most importantly for the students. Remote learning has resulted in long-term social isolation and limitations in interaction with peers. It has also been noted that about 30% of students have symptoms of depression and increased levels of perceived stress, which during the COVID-19 pandemic affects about 50% of young people. Many factors have an impact on this condition, besides the epidemic situation, the social mood and the numerous restrictions, the prolonged time spent online and the reduced level of physical activity have an additional negative impact on their mental health. Due to the dynamic situation of the pandemic, there is a lack of current studies on the mental state of young people especially in the context of ongoing e-learning. Therefore, it was decided to investigate what is the prevalence of depressive disorders and the level of perceived stress during the ongoing remote learning in the group of students of 8 European Universities among Poland, Slovakia and Lithuania.
- Conditions
- Anxiety, Depression
- Being tested
- Stress Levels and Mental Well-Being assessment
- Keywords
- depression, anxiety, COVID-19, e-Learning
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Levels and Mental Well-Being assessmentDiagnostic test
At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.
| Study group | Role | What they receive |
|---|---|---|
| Students from 8 European Universities, regardless of field of study and academic year | At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities. Receives: Diagnostic Test: Stress Levels and Mental Well-Being assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Stress Questionnaire (PSQ)
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
Measured: 20 minutes
Beck's Depression Inventory
The BDI-II is a tool used to determine the degree of intensity of depressive symp-toms. The 21-item questionnaire consists of two parts: emotional and somatic. Depending on the number of points obtained, the severity of depression can be assessed. A range of 0-10 points indicates no depression, 11-27 indicates moderate mood disorder, and 28 indicates major depressive disorder. The cutoff for dividing patients into depressive and non-depressive subgroups was a score of 10, following the guidelines given by Beck et al.
Measured: 20 minutes
Authors' survey
The survey contains five sections on the impact of e-learning on various aspects of life. The survey responses were structured on a 5-point Likert scale from 1 to 5, where 1 refers to "strongly disagree" statement and 5 to "definitely agree". Questions were grouped into areas: Social life (3 questions), Education skills (4 questions), Eco-nomic field (2 questions), Nutrition habits and drugs (2 questions). The questionnaire showed satisfactory reliability with a Cronbach alpha of 0.82.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start15 Feb 2021
- Primary completion1 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 4,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Szczepańska-Gieracha, Prof, Study director, The University School of Physical Education in WroclawAnna Rutkowska, PhD, Principal investigator, The Opole University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926441
- Sponsor's protocol ID
- COVID_International
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Levels and Mental Well-Being Among Polish, Slovakian and Lithuanian Students During E-learning
- ClinicalTrials.gov ID
- NCT04926441
- Acronym / sponsor ID
- COVID_International
- Conditions
- Anxiety, Depression
- Keywords
- depression, anxiety, COVID-19, e-Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,870 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Jun 2021 (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.
Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Polish, Slovak and Lithuanian Students.
Detailed description
The COVID-19 pandemic has had the effect of accelerating changes in educational processes around the world. It resulted in a rapid conversion from face-to-face to online classes. This has disrupted the regular pattern of education and standard practices that have been followed for many years. It is a big organizational challenge for the academics but most importantly for the students. Remote learning has resulted in long-term social isolation and limitations in interaction with peers. It has also been noted that about 30% of students have symptoms of depression and increased levels of perceived stress, which during the COVID-19 pandemic affects about 50% of young people. Many factors have an impact on this condition, besides the epidemic situation, the social mood and the numerous restrictions, the prolonged time spent online and the reduced level of physical activity have an additional negative impact on their mental health. Due to the dynamic situation of the pandemic, there is a lack of current studies on the mental state of young people especially in the context of ongoing e-learning. Therefore, it was decided to investigate what is the prevalence of depressive disorders and the level of perceived stress during the ongoing remote learning in the group of students of 8 European Universities among Poland, Slovakia and Lithuania.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students from 8 European Universities, regardless of field of study and academic year | – | Diagnostic Test: Stress Levels and Mental Well-Being assessmentAt the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students participating in active learning
Key inclusion criteria (1 listed)
- Students attending the course cycle
Key exclusion criteria (2 listed)
- Inability to self-complete the research questionnaires;
- Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;
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 |
|---|---|---|
| Stress Levels and Mental Well-Being assessmentAt the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities. | Diagnostic test | Students from 8 European Universities, regardless of field of study and academic year |
Primary outcome
Perception of Stress Questionnaire (PSQ)
Time frame: 20 minutes
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
Beck's Depression Inventory
Time frame: 20 minutes
The BDI-II is a tool used to determine the degree of intensity of depressive symp-toms. The 21-item questionnaire consists of two parts: emotional and somatic. Depending on the number of points obtained, the severity of depression can be assessed. A range of 0-10 points indicates no depression, 11-27 indicates moderate mood disorder, and 28 indicates major depressive disorder. The cutoff for dividing patients into depressive and non-depressive subgroups was a score of 10, following the guidelines given by Beck et al.
Authors' survey
Time frame: 10 minutes
The survey contains five sections on the impact of e-learning on various aspects of life. The survey responses were structured on a 5-point Likert scale from 1 to 5, where 1 refers to "strongly disagree" statement and 5 to "definitely agree". Questions were grouped into areas: Social life (3 questions), Education skills (4 questions), Eco-nomic field (2 questions), Nutrition habits and drugs (2 questions). The questionnaire showed satisfactory reliability with a Cronbach alpha of 0.82.
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 15 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Joanna Szczepańska-Gieracha, Prof study director
The University School of Physical Education in Wroclaw
Anna Rutkowska, PhD principal investigator
The Opole University of Technology
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by The Opole University of Technology at 8 sites in 3 countries.
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 1 inclusion and 2 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Slovakia, Poland, Lithuania. 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?
Perception of Stress Questionnaire (PSQ) (time frame: 20 minutes). The study lists 3 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 15 Jun 2021.