NCT04371250

Brief Summary

The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries. This online survey assesses these measures implications on Mental Health in emerging adults. The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures. At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 22, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

April 22, 2020

Last Update Submit

February 8, 2022

Conditions

Keywords

Mental HealthEmerging Adulthood

Outcome Measures

Primary Outcomes (2)

  • Self-rated measure of Resilience

    Measured with the Resilience Scale for Adults (RSA).

    Up to 1 week after the end of the lock-down measures

  • Self-rated measure of Loneliness

    Measured with the UCLA (University of California, Los Angeles) Loneliness Scale.

    Up to 1 week after the end of the lock-down measures

Study Arms (1)

Youth

Assessed group

Other: Survey and Questionnaire

Interventions

Resilience and Loneliness questionnaires

Youth

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy youth living in a European Country where SARS-CoV2 Pandemic Lock-down Measures are underway.

You may qualify if:

  • French-speaking or Italian-speaking
  • Subjects who accepted to participated to the online survey
  • Inhabitants of a European country where SARS-CoV2 Pandemic Lock-down Measures are underway
  • Survey filling date up to one week after the end of Lock-down Measures in the Country of residence

You may not qualify if:

  • Incomplete surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (7)

  • Boffo, M., Mannarini, S., & Munari, C. (2012). Exploratory Structure Equation Modeling of the UCLA Loneliness Scale: A contribution to the Italian adaptation. TPM: Testing, Psychometrics, Methodology in Applied Psychology, 19(4).

    BACKGROUND
  • Bonfiglio NS, Renati R, Hjemdal O, Friborg O. The resilience scale for adults in italy: A validation study comparing clinical substance abusers with a nonclinical sample. Psychol Addict Behav. 2016 Jun;30(4):509-15. doi: 10.1037/adb0000176. Epub 2016 Mar 31.

    PMID: 27031088BACKGROUND
  • Friborg, O., Martinussen, M., & Rosenvinge, J. H. (2006). Likert-based vs. semantic differential-based scorings of positive psychological constructs: A psychometric comparison of two versions of a scale measuring resilience. Personality and Individual Differences, 40(5), 873-884. https://doi.org/10.1016/j.paid.2005.08.015

    BACKGROUND
  • Grace, G. D. E., Joshi, P., Pelletier, R., & Laval, U. (1993). L'Echelle de solitude de l'Universite Laval ( ESUL ): validation canadienne-francaise du UCLA Loneliness Scale. (1959), 12-27.

    BACKGROUND
  • Hjemdal, O., Friborg, O., Braun, S., Kempenaers, C., Linkowski, P., & Fossion, P. (2011). The resilience scale for adults: Construct validity and measurement in a Belgian sample. International Journal of Testing, 11(1), 53-70. https://doi.org/10.1080/15305058.2010.508570

    BACKGROUND
  • Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.

    PMID: 17551351BACKGROUND
  • Marcoen A, Goossens L, Caes P. Lonelines in pre-through late adolescence: Exploring the contributions of a multidimensional approach. J Youth Adolesc. 1987 Dec;16(6):561-77. doi: 10.1007/BF02138821.

    PMID: 24277491BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

April 22, 2020

First Posted

May 1, 2020

Study Start

April 30, 2020

Primary Completion

May 31, 2020

Study Completion

December 30, 2020

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations