NCT04769284

Brief Summary

University students report high levels of stress, anxiety and depression every year, which, according to some research, responsible for university administration and popular media, constitutes a global crisis of mental health of students at these levels. Exposure to academic stress directly compromises students' motivation and attitudes towards learning. High levels of perceived distress in the face of inadequate resources to deal with the situation leaves people at risk of developing major psychiatric problems, especially when this distress is prolonged or severe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

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 12, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

8 days

First QC Date

February 23, 2021

Last Update Submit

February 23, 2021

Conditions

Stress, PsychologicalAnxietyDepressionCovid19

Keywords

university studentsphysical activitygender stereotype

Outcome Measures

Primary Outcomes (2)

  • Modified version of EPP-10 related to COVID-19 (EPP-10-C)

    EEP-10-C; modified version of the 10-item perceived stress scale (EEP-10), it is also composed of 10 items; each offers 5 response options: never, almost never, occasionally, almost always, and always. Items 1, 2, 3, 6, 9 and 10 are scored directly from 0 to 4 and items 4, 5, 7 and 8, conversely, from 4 to 0

    3 minutes

  • Abbreviated Goldberg Anxiety Scale EADG

    It examines four fundamental psychiatric areas: depression, anxiety, social inadequacy, and hypochondria. It contains 9 questions and the cut-off points are equal to or greater than 4 for the anxiety scale, and equal to or greater than 2 for the depression scale.

    3 minutes

Secondary Outcomes (2)

  • Gender stereotypes: Short version of the Bem Sex Rol Inventory (BRSI).

    4 minutes

  • Short International Physical Activity Questionnaire (IPAQ)

    4 minutes

Other Outcomes (1)

  • Sociodemographic variables

    4 minutes

Interventions

Mental health studentOTHER

An ad-hoc questionnaire was designed that included sociodemographic variables related to the characteristics of the students. The variables sex, age, degree, employment situation, coexistence situation, economic situation, origin environment, country of origin, time of residence in the Spanish State were collected. Personal variables: * Gender stereotypes: Short version of the Bem Sex Rol Inventory (BRSI). * International Physical Activity Questionnaire (IPAQ) * Abbreviated Goldberg Anxiety Scale EADG * Modified version of EPP-10 related to COVID-19 (EPP-10-C)

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailsmen woman non-binary others
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be made up of nursing, physiotherapy and occupational therapy students from the Faculty of Health Sciences of Zaragoza. Students will be able to answer the questions through their electronic devices. At no time will it be known which student has responded since he is totally anonymous and voluntary.

You may qualify if:

  • Students of the degree of nursing, occupational therapy and physiotherapy belonging to the Faculty of Health Sciences

You may not qualify if:

  • Not belonging to any degree in Health Sciences of the Faculty of Health Sciences

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. Zaragoza's University

Zaragoza, 50009, Spain

Location

Related Publications (7)

  • Bao Y, Sun Y, Meng S, Shi J, Lu L. 2019-nCoV epidemic: address mental health care to empower society. Lancet. 2020 Feb 22;395(10224):e37-e38. doi: 10.1016/S0140-6736(20)30309-3. Epub 2020 Feb 7. No abstract available.

    PMID: 32043982RESULT

  • Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

    PMID: 31986257RESULT

  • Odriozola-Gonzalez P, Planchuelo-Gomez A, Irurtia MJ, de Luis-Garcia R. Psychological symptoms of the outbreak of the COVID-19 confinement in Spain. J Health Psychol. 2022 Mar;27(4):825-835. doi: 10.1177/1359105320967086. Epub 2020 Oct 30.

    PMID: 33124471RESULT

  • Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.

    PMID: 32113704RESULT

  • Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.

    PMID: 32183901RESULT

  • Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

    PMID: 32112714RESULT

  • Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.

    PMID: 32155789RESULT

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersDepressionCOVID-19Motor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Beatriz F Rodríguez Roca

    Zaragoza´s University

    STUDY DIRECTOR

  • Estela F Calatayud Sanz

    Zaragoza´s University

    STUDY DIRECTOR

  • Isabel F Gómez Soria

    Zaragoza´s University

    STUDY DIRECTOR

  • Ángel M Gasch Gallén

    Zaragoza´s University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigador

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 24, 2021

Study Start

February 12, 2021

Primary Completion

February 20, 2021

Study Completion

February 21, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

ES(1)