Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic

NCT04383470 | Unknown

• 1 other identifier: COH-FIT
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, cross-sectional, multi-center, multi-wave survey, assessing characteristics and predictors of physical and mental health as well as health behaviors during COVID-19 pandemic, targeting the general population (children, adolescents and adults).

Conditions

Mental Health Wellness 1; Pandemic

Keywords

COVID-19; Mental Health; Physical Health; Infection; Resilience

Outcome Measures

Primary Outcomes (3)

• Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic

  Primary outcome in the wave 1 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

  wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

• Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks 6 months after WHO declares pandemic over COVID-19 pandemic

  Primary outcome in the wave 2 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks six months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

  wave 2 - change from before to 6 months after pandemic

• Mental health symptoms change, well-being change from last 2 weeks before the pandemic to last 2 weeks 12 months after WHO declares pandemic over COVID-19 pandemic

  Primary outcome in the wave 3 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks 12 months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).

  wave 3 - change from before to 12 months after pandemic (after the pandemic outbreak has been declared from WHO, and until the pandemic outbreak has been declared conlucded by WHO)

Secondary Outcomes (24)

• Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

  wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

• Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

  wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

• Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic

  wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)

• Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic

  wave 2 - change from before to 6 months after pandemic

• Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic

  wave 2 - change from before to 6 months after pandemic

Study Arms (3)

General population, during COVID pandemic

General population during COVID-19 pandemic. Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

General population, 6 months after COVID pandemic

General population, 6 months after COVID pandemic Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

General population, 12 months after COVID pandemic

General population, 12 months after COVID pandemic Adults, adolescents, and children aged 6 years or older. People working in health-care, police, fire-, and military-service vs others. People with physical illness vs others. People with mental illness vs others. Different continents, countries, and regions.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may qualify if:

• General population
• Consenting to the study (adults)
• Guardians consenting to study participation of children and adolescents

You may not qualify if:

• Not consenting to the study (adults)
• Not assenting to the study (children and adolescents)
• age \< 6 years old

Sponsors & Collaborators

• University of Padova: lead
• Northwell Health: collaborator
• Donald and Barbara Zucker School of Medicine at Hofstra/Northwell: collaborator

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

Related Publications (1)

• Agorastos A, Thompson T, Solmi M, Cortese S, Estrade A, Radua J, Dragioti E, Vancampfort D, Thygesen LC, Aschauer H, Schlogelhofer M, Aschauer E, Schneeberger A, Huber CG, Hasler G, Conus P, Do Cuenod KQ, von Kanel R, Arrondo G, Fusar-Poli P, Gorwood P, Llorca PM, Krebs MO, Scanferla E, Kishimoto T, Rabbani G, Skonieczna-Zydecka K, Brambilla P, Favaro A, Takamiya A, Zoccante L, Colizzi M, Bourgin J, Kaminski K, Moghadasin M, Seedat S, Matthews E, Wells J, Vassilopoulou E, Gadelha A, Su KP, Kwon JS, Kim M, Lee T, Papsuev O, Mankova D, Boscutti A, Gerunda C, Saccon D, Righi E, Monaco F, Croatto G, Cereda G, Demurtas J, Brondino N, Veronese N, Enrico P, Politi P, Ciappolino V, Pfennig A, Bechdolf A, Meyer-Lindenberg A, Kahl KG, Domschke K, Bauer M, Koutsouleris N, Winter SM, Borgwardt S, Bitter I, Balazs J, Czobor P, Unoka Z, Mavridis D, Tsamakis K, Bozikas VP, Tunvirachaisakul C, Maes M, Rungnirundorn T, Supasitthumrong T, Haque A, Brunoni AR, Costardi CG, Schuch FB, Polanczyk G, Luiz JM, Fonseca L, Aparicio LV, Valvassori SS, Nordentoft M, Vendsborg P, Hoffmann SH, Sehli J, Sartorius N, Heuss SC, Guinart D, Hamilton J, Kane J, Rubio J, Sand M, Koyanagi A, Solanes A, Andreu-Bernabeu A, Caceres ASJ, Arango C, Diaz-Caneja CM, Hidalgo-Mazzei D, Vieta E, Gonzalez-Penas J, Fortea L, Parellada M, Fullana MA, Verdolini N, Andrlikova E, Janku K, Millan MJ, Honciuc M, Moniuszko-Malinowska A, Loniewski I, Samochowiec J, Kiszkiel L, Marlicz M, Sowa P, Marlicz W, Spies G, Stubbs B, Firth J, Sullivan S, Darcin AE, Aksu H, Dilbaz N, Noyan O, Kitazawa M, Kurokawa S, Tazawa Y, Anselmi A, Cracco C, Machado AI, Estrade N, De Leo D, Curtis J, Berk M, Carvalho AF, Ward P, Teasdale S, Rosenbaum S, Marx W, Horodnic AV, Oprea L, Alexinschi O, Ifteni P, Turliuc S, Ciuhodaru T, Bolos A, Matei V, Nieman DH, Sommer I, van Os J, van Amelsvoort T, Sun CF, Guu TW, Jiao C, Zhang J, Fan J, Zou L, Yu X, Chi X, de Timary P, van Winkel R, Ng B, Pena E, Arellano R, Roman R, Sanchez T, Movina L, Morgado P, Brissos S, Aizberg O, Mosina A, Krinitski D, Mugisha J, Sadeghi-Bahmani D, Sheybani F, Sadeghi M, Hadi S, Brand S, Errazuriz A, Crossley N, Ristic DI, Lopez-Jaramillo C, Efthymiou D, Kuttichira P, Kallivayalil RA, Javed A, Afridi MI, James B, Seb-Akahomen OJ, Fiedorowicz J, Daskalakis J, Yatham LN, Yang L, Okasha T, Dahdouh A, Tiihonen J, Shin JI, Lee J, Mhalla A, Gaha L, Brahim T, Altynbekov K, Negay N, Nurmagambetova S, Jamei YA, Weiser M, Correll CU. Mental health, coping and related risk factors during the first 2 years of the COVID-19 pandemic in children: Nationally representative, multi-wave, cross-sectional results from 12 countries from the global COH-FIT study. Eur Neuropsychopharmacol. 2025 Dec 18;104:112741. doi: 10.1016/j.euroneuro.2025.112741. Online ahead of print.

  PMID: 41418519 DERIVED

Related Links

• COH-FIT Survey

MeSH Terms

Conditions

COVID-19; Psychological Well-Being; Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior

Study Officials

• Christoph U. Correll, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Marco Solmi, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

• Agorastos Agorastos, MD

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

• Andres Estradè, MSc

  Universidad Católica del Uruguay

  STUDY DIRECTOR

Central Study Contacts

Marco Solmi, MD

CONTACT

+390498213829; marco.solmi@unipd.it

Marco Solmi, MD

CONTACT

marco.solmi@unipd.it

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 12, 2020
• Study Start: April 26, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

GR (1)