NCT04926441

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,870

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

14 days

First QC Date

June 13, 2021

Last Update Submit

June 13, 2021

Conditions

Keywords

depressionanxietyCOVID-19e-Learning

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    10 minutes

Study Arms (1)

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.

Diagnostic Test: Stress Levels and Mental Well-Being assessment

Interventions

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.

Students from 8 European Universities, regardless of field of study and academic year

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Students participating in active learning

You may qualify if:

  • Students attending the course cycle

You may not qualify if:

  • Inability to self-complete the research questionnaires;
  • Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Lithuanian Sports University

Kaunas, 44221, Lithuania

Location

Jan Dlugosz University in Czestochowa

Częstochowa, 42-200, Poland

Location

Faculty of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

Location

The University School of Physical Education in Wroclaw

Wroclaw, 50-254, Poland

Location

Slovak Medical University in Bratislava

Banská Bystrica, 874 05, Slovakia

Location

Matej Bel University

Banská Bystrica, 974 01, Slovakia

Location

Technical University of Košice

Košice, 042 00, Slovakia

Location

Constantine the Philosopher University in Nitra

Nitra, 949 01, Slovakia

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joanna Szczepańska-Gieracha, Prof

    The University School of Physical Education in Wroclaw

    STUDY DIRECTOR
  • Anna Rutkowska, PhD

    The Opole University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 15, 2021

Study Start

February 15, 2021

Primary Completion

March 1, 2021

Study Completion

April 30, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations