MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain

NCT04556565 | Unknown

• 1 other identifier: 2020/9203/I
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 18

Brief Summary

The aim of the proposed project is to provide a comprehensive assessment of the mental health impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study of three groups will be conducted: (1) COVID-19 cases or close contacts recently isolated or quarantined; (2) healthcare workers; (3) adult general population. Recruitment through epidemiologic surveillance services, hospitals, primary care centers in 6 Spanish Autonomous Communities (groups 1 \& 2) and a random sample of individuals using telephone numbers as the sampling frames(group 3). Web-based surveys or telephone interviews at baseline and 6-month follow-up assess: current living and employment status; COVID-19 infection status; mental health (post-traumatic stress, panic, depression, anxiety, alcohol and substance use, suicidality; services use); psychological functioning; general health status and quality of life. Specific modules focus on isolation or quarantine (group 1) and care for COVID-19 patients (group 2). Short bi-weekly brief follow-up surveys among groups 1 \& 2 will provide additional assessment of main outcomes in the two months following baseline assessment.

Conditions

Covid19; Mental Health Disorder; Mental Health Conditions

Keywords

COVID-19 outbreak; Health workers; Mental Health; Suicidal thoughts and behaviours; Depression; Anxiety; Post-Traumatic Stress Disorder; General Population; Close contacts; Lockdown

Outcome Measures

Primary Outcomes (4)

• Post-traumatic stress disorder

  It will be assessed with the 4-item version of the PTSD checklist for DSM-5 (PCL-5), which evaluates the presence and severity of 4 DSM-5 Criteria symptoms of PTSD over the past month (0 = not at all to 4 = extremely) and has been shown to generate diagnoses that closely parallel those of the full PCL-5 (AUC\>0.9), making it well-suited for screening. The Spanish version is available.

  6 months

• Depression

  It will be evaluated with the Patient Health Questionnaire 8-item version (PHQ-8) with a 2-week recall period. Items have four response categories on frequency of the symptom that can be summed up to obtain a severity score, with cut-points of 5, 10, and 15 representing mild, moderate, and severe levels of depression, respectively, showing good diagnostic accuracy for depressive disorder (AUC\>0.90) and high reliability (\>0.8).

  6 months

• Generalized Anxiety Disorder

  It will be screened with the seven-item Generalized Anxiety Disorder scale (GAD-7). Cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety, respectively, with AUC\>0.8 for the detection of anxiety. The Spanish versions of the PHQ and GAD-7 have been developed (https://www.phqscreeners.com).

  6 months

• Suicidal thoughts and behaviors

  It will be evaluated with a modified version of the Columbia Suicide Severity Rating Scale, including passive suicidal ideation ("wish you were dead or would go to sleep and never wake up"), active suicidal ideation ("have thoughts of killing yourself"), suicide plans ("think about how you might kill yourself \[e.g., taking pills, shooting yourself\] or work out a plan of how to kill yourself"), and suicide attempt ("make a suicide attempt \[i.e., purposefully hurt yourself with at least some intent to die\]).It has been translated into Spanish showing good discrimination ability for suicidal behavior.

  6 months

Secondary Outcomes (5)

• Alcohol and drug use problems

  6 months

• Panic attacks

  6 months

• Health-related Quality of Life

  6 months

• Overall Perceived Health

  6 months

• Role limitation

  6 months

Study Arms (3)

General population

A representative sample of the general adult population (including those tele-working and working outside of home)

Cases and contacts

Recently isolated or quarantined COVID-19 cases and close contacts

Healthcare workers

Healthcare workers, including medical personnel directly and indirectly involved with patients as well as other personnel (e.g. administrative workers)

Eligibility Criteria

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

Study Population

Three separate population groups will be assessed: (1) recently isolated or quarantined COVID-19 cases and close contacts; (2) healthcare workers, including medical personnel directly and indirectly involved with patients as well as other personnel (e.g. administrative workers); (3) a representative sample of the general adult population (including those tele-working and working outside of home).

You may qualify if:

• Recently isolated or quarantined cases and close contacts:
• a) Individuals aged 18 or older; and b) laboratory confirmed or suspected COVID-19 cases or quarantined close contacts.
• Healthcare workers:
• a) health center employees currently working in the participating institutions, including medical and nursing personnel directly and indirectly involved with patients as well as all other personnel (administrative workers, logistic workers, etc.); and b) aged 18 years or older.
• Spanish general adult population:
• residents in Spain; b) aged 18 years or older; c) with a land-line or mobile telephone

You may not qualify if:

• Recently isolated or quarantined cases and close contacts:
• a) individuals too sick to participate (but they will become eligible after clinical improvement); b) unable to understand the survey language; and c) do not provide explicit consent to participate.
• Healthcare workers:
• a) individuals too sick to participate (but they will become eligible after clinical improvement); b) unable to understand the survey language; and c) do not provide explicit consent to participate.
• Spanish general adult population:
• unable to understand the survey language; and b) do not provide explicit consent to participate.

Sponsors & Collaborators

• Jordi Alonso: lead
• Hospital Universitario 12 de Octubre: collaborator
• Instituto de Salud Carlos III: collaborator
• Universitat Pompeu Fabra: collaborator
• Public Health Agency of Barcelona: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Sistema de Emergencias Médicas de Cataluña (SEM): collaborator
• Agència de Qualitat i Avaluació Sanitàries: collaborator
• Gerencia de Atención Primaria de Madrid-FIIBAP: collaborator
• Hospital del Mar: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Fundacion Clinic per a la Recerca Biomédica: collaborator
• Hospital Vall d'Hebron: collaborator
• Hospital Clínico Universitario de Valencia: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario Principe de Asturias: collaborator
• Hospital El Bierzo: collaborator
• Hospital Universitario Araba: collaborator
• Hospital Donostia: collaborator
• Hospital de Cruces: collaborator
• Hospital Universitario Torrecárdenas: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator

Study Sites (18)

Hospital Universitario Príncipe Asturias

Alcalá de Henares, Spain

Location

Hospital Universitario Torrecárdenas

Almería, Spain

Location

Agència de Salut Pública Barcelona

Barcelona, Spain

Location

Fundació Clínic per a la Recerca Biomèdica

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Institut d'Investigación en Atenció Primària, IDIAP Jordi Gol

Barcelona, Spain

Location

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Parc Sanitari Sant Joan de Déu

Barcelona, Spain

Location

Psmar-Imim

Barcelona, Spain

Location

Sistema de Emergencias Médicas de Cataluña

Barcelona, Spain

Location

Hospital Universitario Cruces

Bilbao, Spain

Location

Hospital El Bierzo

León, Spain

Location

Gerencia de Atención Primaria de Madrid-FIIBAP

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Spain

Location

Hospital Universitario Donostia

San Sebastián, Spain

Location

Hospital Clínic Universitari

Valencia, Spain

Location

Hospital Universitario Araba-Santiago

Vitoria-Gasteiz, Spain

Location

Related Publications (4)

• Petri-Romao P, Stoffers-Winterling J, Doerschner C, Jurgeit J, Godde P, Hecker I, Melchior M, Czepiel D, Witteveen A, van der Ven E, Sijbrandij M, Mediavilla R, Ayuso-Mateos JL, Smith P, Lorant V, Monistrol Mula A, Haro Abad JM, Gemes K, Mittendorder-Rutz E, Monzio Compagnoni M, Lora A, Caggiu G, Conflitti C, Kalisch R, Lieb K. Co-RESPOND: a federated network of cohorts on mental health and adversity during the COVID-19 pandemic. Challenges, solutions and recommendations for retrospective data harmonization. Eur J Psychotraumatol. 2025 Dec;16(1):2517920. doi: 10.1080/20008066.2025.2517920. Epub 2025 Aug 12.

  PMID: 40791144 DERIVED

• Alayo I, Pujol O, Alonso J, Ferrer M, Amigo F, Portillo-Van Diest A, Aragones E, Aragon Pena A, Asunsolo Del Barco A, Campos M, Espuga M, Gonzalez-Pinto A, Haro JM, Lopez-Fresnena N, Martinez de Salazar AD, Molina JD, Orti-Lucas RM, Parellada M, Pelayo-Teran JM, Forjaz MJ, Perez-Zapata A, Pijoan JI, Plana N, Polentinos-Castro E, Puig MT, Rius C, Sanz F, Serra C, Urreta-Barallobre I, Bruffaerts R, Vieta E, Perez-Sola V, Mortier P, Vilagut G; MINDCOVID Working group. Identifying most important predictors for suicidal thoughts and behaviours among healthcare workers active during the Spain COVID-19 pandemic: a machine-learning approach. Epidemiol Psychiatr Sci. 2025 May 8;34:e28. doi: 10.1017/S2045796025000198.

  PMID: 40340775 DERIVED

• Alonso J, Vilagut G, Alayo I, Ferrer M, Amigo F, Aragon-Pena A, Aragones E, Campos M, Del Cura-Gonzalez I, Urreta I, Espuga M, Gonzalez Pinto A, Haro JM, Lopez Fresnena N, Martinez de Salazar A, Molina JD, Orti Lucas RM, Parellada M, Pelayo-Teran JM, Perez Zapata A, Pijoan JI, Plana N, Puig MT, Rius C, Rodriguez-Blazquez C, Sanz F, Serra C, Kessler RC, Bruffaerts R, Vieta E, Perez-Sola V, Mortier P; MINDCOVID Working group. Mental impact of Covid-19 among Spanish healthcare workers. A large longitudinal survey. Epidemiol Psychiatr Sci. 2022 Apr 29;31:e28. doi: 10.1017/S2045796022000130.

  PMID: 35485802 DERIVED

• Mortier P, Vilagut G, Ferrer M, Alayo I, Bruffaerts R, Cristobal-Narvaez P, Del Cura-Gonzalez I, Domenech-Abella J, Felez-Nobrega M, Olaya B, Pijoan JI, Vieta E, Perez-Sola V, Kessler RC, Haro JM, Alonso J; MINDCOVID Working group; MINDCOVID Working group. Thirty-day suicidal thoughts and behaviours in the Spanish adult general population during the first wave of the Spain COVID-19 pandemic. Epidemiol Psychiatr Sci. 2021 Feb 17;30:e19. doi: 10.1017/S2045796021000093.

  PMID: 34187614 DERIVED

MeSH Terms

Conditions

COVID-19; Mental Disorders; Psychological Well-Being; Suicidal Ideation; Behavior; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Jordi Alonso, MD

  Institut Hospital del Mar d'Investigacions Mèdiques

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Coordinator of the Health Services Research Group, Director of the Epidemiology and Public Health Program

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 21, 2020
• Study Start: May 8, 2020
• Primary Completion: November 7, 2021
• Study Completion: November 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

ES (18)