Mental Health Wellness 1COH-FITNCT04383470
Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic
An observational study of Mental Health Wellness 1 and Pandemic, run by University of Padova at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Pandemic
- How many people
- 100,000 participants
- Where
- 1 siteGreece
- Study dates
- 26 Apr 2020to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General population
Who may be able to join
- General population
- Consenting to the study (adults)
- Guardians consenting to study participation of children and adolescents
Who cannot join
- Not consenting to the study (adults)
- Not assenting to the study (children and adolescents)
- age < 6 years old
Trial locations and contacts
1 site in 1 country.
Marco Solmi, MD contact
Greece1 site, 1 recruiting
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki
Agorastos Agorastos
About this study
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).
Read the detailed description
In March 2020, the World Health Organization declared the COVID-19 (known as Coronavirus) virus a global pandemic. COVID-19 is a variant of coronavirus thought to originate in Wuhan province China. Up until April 7, 2020, as many as 1,346,299 individuals had confirmed COVID-19 infection, with already 74,679 deaths from COVID-19 complications.
The hypothesis of this study is that the physical and mental health of the general population and health care workers involved in the management of COVID-19 infected people is heavily affected by COVID-19, but that risk and protective factors exist.
Investigators plan to distribute 3 different surveys based on the age group. The first survey, COH-FIT-Adults/ (COH-FIT-A), will be distributed the general adult (age >/= 18 years old) population in North America, South America, Europe, Asia, Africa and Australia via an online link, making the general population aware of the project via public announcements, social media and regular media coverage outlets, or via specialized institutes and agencies (e.g., opinion research centers) that are capable of using a randomly selected, nationally representative sample (potentially funded by national / local grant applications). For the subgroup of adult health-care professionals, additionally, survey distribution mechanisms will be used that utilize medical professional organizations and associations, hospital and university anonymized channels.
Guardians of adolescents aged 14-17 years old will be asked to provide electronic consent for their adolescent to participate in the COH-FIT-AD survey after having taken the survey and being familiar with the questions, being informed that the one question having sexuality as the content will be omitted from the adolescent version. Guardians of children aged 6-13 years old will be able to review the survey questions that children would answer before electronically consenting to participate.
- Conditions
- Mental Health Wellness 1, Pandemic
- Keywords
- COVID-19, Mental Health, Physical Health, Infection, Resilience
- Medical subject headings
- COVID-19, Psychological Well-Being, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: 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
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
Measured: 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
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: 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
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: 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
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
Measured: wave 2 - change from before to 6 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: wave 2 - change from before to 6 months after pandemic
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: wave 3 - change from before to 12 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
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
Measured: wave 3 - change from before to 12 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measured: wave 3 - change from before to 12 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measured: 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 general physical health, self-rated, on a VAS scale from 0 to 100.
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measured: wave 2 - change from before to 6 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measured: wave 3 - change from before to 12 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measured: 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 general mental health, self-rated, on a VAS scale from 0 to 100.
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measured: wave 2 - change from before to 6 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measured: wave 3 - change from before to 12 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measured: 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 easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measured: wave 2 - change from before to 6 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measured: wave 3 - change from before to 12 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measured: 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 medication adherence, self-rated a on a VAS scale from 0 to 100.
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measured: wave 2 - change from before to 6 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measured: wave 3 - change from before to 12 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measured: 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 functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measured: wave 2 - change from before to 6 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measured: wave 3 - change from before to 12 months after pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start26 Apr 2020
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
- Responsible party
- Sponsor
- Investigators
- Christoph U. Correll, MD, Principal investigator, Northwell HealthMarco Solmi, MD, Principal investigator, University of PadovaAgorastos Agorastos, MD, Study director, Aristotle University Of ThessalonikiAndres Estradè, MSc, Study director, Universidad Católica del Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383470
- Sponsor's protocol ID
- COH-FIT
- Acronym
- COH-FIT
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Mar;104:112741. doi: 10.1016/j.euroneuro.2025.112741. Epub 2025 Dec 18.
PubMed 41418519
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Outcomes Study on Health and Functioning During Infection Times During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04383470
- Acronym / sponsor ID
- COH-FIT / COH-FIT
- Conditions
- Mental Health Wellness 1, Pandemic
- Keywords
- COVID-19, Mental Health, Physical Health, Infection, Resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
- Study start
- 26 Apr 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In March 2020, the World Health Organization declared the COVID-19 (known as Coronavirus) virus a global pandemic. COVID-19 is a variant of coronavirus thought to originate in Wuhan province China. Up until April 7, 2020, as many as 1,346,299 individuals had confirmed COVID-19 infection, with already 74,679 deaths from COVID-19 complications.
The hypothesis of this study is that the physical and mental health of the general population and health care workers involved in the management of COVID-19 infected people is heavily affected by COVID-19, but that risk and protective factors exist.
Investigators plan to distribute 3 different surveys based on the age group. The first survey, COH-FIT-Adults/ (COH-FIT-A), will be distributed the general adult (age >/= 18 years old) population in North America, South America, Europe, Asia, Africa and Australia via an online link, making the general population aware of the project via public announcements, social media and regular media coverage outlets, or via specialized institutes and agencies (e.g., opinion research centers) that are capable of using a randomly selected, nationally representative sample (potentially funded by national / local grant applications). For the subgroup of adult health-care professionals, additionally, survey distribution mechanisms will be used that utilize medical professional organizations and associations, hospital and university anonymized channels.
Guardians of adolescents aged 14-17 years old will be asked to provide electronic consent for their adolescent to participate in the COH-FIT-AD survey after having taken the survey and being familiar with the questions, being informed that the one question having sexuality as the content will be omitted from the adolescent version. Guardians of children aged 6-13 years old will be able to review the survey questions that children would answer before electronically consenting to participate.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population
Key inclusion criteria (3 listed)
- General population
- Consenting to the study (adults)
- Guardians consenting to study participation of children and adolescents
Key exclusion criteria (3 listed)
- Not consenting to the study (adults)
- Not assenting to the study (children and adolescents)
- age < 6 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic
Time frame: 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)
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).
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
Time frame: wave 2 - change from before to 6 months after 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).
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
Time frame: 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)
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).
24 secondary outcomes
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: wave 2 - change from before to 6 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Time frame: wave 2 - change from before to 6 months after pandemic
Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Time frame: wave 3 - change from before to 12 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
Time frame: wave 3 - change from before to 12 months after pandemic
Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Time frame: wave 3 - change from before to 12 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Time frame: 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 general physical health, self-rated, on a VAS scale from 0 to 100.
Time frame: wave 2 - change from before to 6 months after pandemic
Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Time frame: wave 3 - change from before to 12 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Time frame: 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 general mental health, self-rated, on a VAS scale from 0 to 100.
Time frame: wave 2 - change from before to 6 months after pandemic
Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Time frame: wave 3 - change from before to 12 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Time frame: 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 easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 2 - change from before to 6 months after pandemic
Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 3 - change from before to 12 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Time frame: 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 medication adherence, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 2 - change from before to 6 months after pandemic
Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 3 - change from before to 12 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Time frame: 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 functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 2 - change from before to 6 months after pandemic
Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Time frame: wave 3 - change from before to 12 months after pandemic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 41418519Agorastos 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. 2026 Mar;104:112741. doi: 10.1016/j.euroneuro.2025.112741. Epub 2025 Dec 18.
- COH-FIT SurveyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Solmi, MD contact
Christoph U. Correll, MD principal investigator
Northwell Health
Marco Solmi, MD principal investigator
University of Padova
Agorastos Agorastos, MD study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1 and Pandemic, run by University of Padova at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Solmi, MD (+390498213829, marco.solmi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.