NCT04378452

Brief Summary

It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, these front-line staff are exposed to high levels of stress and anxiety. This gets worse as the pressure on the health system increases, forcing them to deal with significant ethical issues. To respond to all these issues, the research group led by Dr. Cris Vilaplana at the Germans Trias i Pujol Research Institute (IGTP), have launched a questionnaire to ask the public, including health professionals, how are they being affected by the pandemic, not only in relation to their health but in terms of their emotional wellbeing and their family finances. The project is an initiative of the SMA-TB consortium (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA is also collaborating in the project. The survey is based on questions related to depression, anxiety, stress, and post-traumatic stress disorder, which have already been used in other epidemic outbreaks and in disaster situations, but it also includes questions adapted to the current situation. The survey (now available in 4 languages) has been designed to be shared using a snowball strategy, making possible for everybody to participate and collaborate. The results obtained will initially help us to better understand the impact of the outbreak of COVID-19 on the general wellbeing of the population and health workers so that we can go on to develop strategies in coordination those in charge of administrations in order to adapt policies to people's real needs. The results of the study will be published in a scientific article and will be publicly available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56,656

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

March 31, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

April 15, 2020

Last Update Submit

July 6, 2023

Conditions

SARS-CoV 2COVID-19Quality of LifeMental Health Wellness 1Social DistanceSARS (Disease)Psychological

Keywords

SARS-CoV-2COVID-19psycho-social impactmental healthinfectious diseases

Outcome Measures

Primary Outcomes (6)

  • Psychological impact of the outbreak, total score

    Psychological impact of the outbreak, total score will be measured by the sum of the depression questions score, the anxiety questions score, the stress questions score and the PSTD questions score. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

    Through study completion, an average of 1 year.

  • Psychological impact of the outbreak: depression questions score

    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

    Through study completion, an average of 1 year.

  • Psychological impact of the outbreak: anxiety questions score

    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

    Through study completion, an average of 1 year.

  • Psychological impact of the outbreak: stress questions score

    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

    Through study completion, an average of 1 year.

  • Psychological impact of the outbreak: PSTD questions score

    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 0-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

    Through study completion, an average of 1 year.

  • Descriptive statistics for the non-psychological questions

    Percentages of response will be calculated according to the number of respondents per each response out of the total number of responses of each question. All results will be given according to the respondents being part of the whole cohort of respondents, according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported per gender, age, country and postal code.

    Through study completion, an average of 1 year.

Study Arms (1)

COM-COVID cohort

Individuals of \>16 years old evaluated during the COVID-19 outbreak by an anonymous survey and willing to respond. Expected timeframe for the collection of completed surveys: March 31th, 2020-September 30th, 2020\]

Behavioral: COM-COVID anonimous survey

Interventions

COM-COVID anonimous surveyBEHAVIORAL

Anonimous e-survey administered to the general population by sharing it through social and mass media, including questions on sociodemographic data, physical symptoms in the past 14 days compatible with SARS-CoV-2 infection, socio-economic impact of the COVID-19 outbreak and psychological impact of the COVID-19 outbreak and mental health status.

COM-COVID cohort

Eligibility Criteria

Age16 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe respondents to the survey can choose one of the following responses to the question: "Which gender do you identify with?": male, female, non binary, I prefer not to say
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All people \>16 years old willing to participate in the COM-COVID survey study during the COVID-19 outbreak (period March 2020-September 2020).

You may qualify if:

  • age = or \>16 years old
  • accepting to participate in the project and filling in the survey questionnaire

You may not qualify if:

  • age \<16 years old
  • non accepting to participate in the project and filling in the survey questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fundació Institut Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Fundació Lluita contra la Sida (FLS, Fight AIDS Foundation)

Badalona, Catalonia, 08916, Spain

Location

Anaxomics biotech

Barcelona, 08007, Spain

Location

Fundació Privada per a la Recerca i la Docència Sant Joan de Déu

Esplugues de Llobregat, Spain

Location

Related Publications (1)

  • Farres J, Ruiz JL, Mas JM, Arias L, Sarrias MR, Armengol C, Cardona PJ, Munoz-Moreno JA, Vilaplana M, Arranz B, Usall J, Serrano-Blanco A, Vilaplana C. Identification of the most vulnerable populations in the psychosocial sphere: a cross-sectional study conducted in Catalonia during the strict lockdown imposed against the COVID-19 pandemic. BMJ Open. 2021 Nov 26;11(11):e052140. doi: 10.1136/bmjopen-2021-052140.

    PMID: 34836903RESULT

Related Links

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromeDiseasePsychological Well-BeingCommunicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorDisease Attributes

Study Officials

  • Cris Vilaplana, MD, PhD

    Fundació Institut Germans Trias i Pujol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

May 7, 2020

Study Start

March 31, 2020

Primary Completion

March 22, 2021

Study Completion

April 7, 2021

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

ES(4)