Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04371250
Other study ID # SRB2020_158
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2020
Est. completion date December 30, 2020

Study information

Verified date February 2022
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date December 30, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Incomplete surveys

Study Design


Intervention

Other:
Survey and Questionnaire
Resilience and Loneliness questionnaires

Locations

Country Name City State
Belgium Erasme University Hospital Brussels

Sponsors (3)

Lead Sponsor Collaborator
Erasme University Hospital King Baudouin Foundation, Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & 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).

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. — View Citation

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

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.

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

Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustün TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04164654 - A Mobile App to Address Student Loneliness N/A
Recruiting NCT05831475 - LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation N/A
Completed NCT05490979 - The Impact of Dyad Exercises on Well-being and Connection in Young Adults N/A
Not yet recruiting NCT05054660 - Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study N/A
Enrolling by invitation NCT04137432 - Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness Phase 1
Not yet recruiting NCT05423899 - Humanoid Robot vs Treatment as Usual for Loneliness N/A
Active, not recruiting NCT05678985 - Evaluating Impact and Implementation of Choose to Move (Phase 4) N/A
Withdrawn NCT04797026 - Penpal Loneliness Project N/A
Enrolling by invitation NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT05520450 - Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
Not yet recruiting NCT05450445 - myHealthHub for Older Adult Inpatients N/A
Active, not recruiting NCT05646329 - The Effect of Motivational Interviewing on Problematic Internet Use and Loneliness N/A
Completed NCT04682535 - Daily Study of Caregiving Relationships and Health
Recruiting NCT04301167 - Loneliness and Health: The Moderating Role of Befriending Services N/A
Completed NCT03124446 - Mindfulness-Based College: Stage 1 N/A
Recruiting NCT04733300 - Online Mindfulness-Based College for Young Adults N/A
Completed NCT04907942 - Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management Phase 1/Phase 2
Recruiting NCT05812989 - Modifiers and Mechanisms of Loneliness Interventions N/A
Enrolling by invitation NCT05574192 - The Social Engagement Project: Addressing Isolation With Women Affected by Violence N/A
Not yet recruiting NCT06070402 - Use of a Voice Assistant to Improve Mental Health in Older People N/A