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

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ClinicalTrials.gov Identifier: NCT04556565
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Hospital Universitario 12 de Octubre
Instituto de Salud Carlos III
Universitat Pompeu Fabra
Public Health Agency of Barcelona
Jordi Gol i Gurina Foundation
Sistema de Emergencias Médicas de Cataluña (SEM)
Agència de Qualitat i Avaluació Sanitàries
Gerencia de Atención Primaria de Madrid-FIIBAP
Hospital del Mar
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundacion Clinic per a la Recerca Biomédica
Hospital Vall d'Hebron
Hospital Clínico Universitario de Valencia
Hospital General Universitario Gregorio Marañon
Hospital Universitario Principe de Asturias
Hospital El Bierzo
Hospital Universitario Araba
Hospital Universitario Donostia
Hospital de Cruces
Hospital Universitario Torrecárdenas
Parc Sanitari Sant Joan de Déu
Information provided by (Responsible Party):
Jordi Alonso, Hospital del Mar Research Institute (IMIM)

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.


Condition or disease
Covid19 Mental Health Disorder Mental Health Conditions

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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. Post-traumatic stress disorder [ Time Frame: 6 months ]
    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.

  2. Depression [ Time Frame: 6 months ]
    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).

  3. Generalized Anxiety Disorder [ Time Frame: 6 months ]
    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).

  4. Suicidal thoughts and behaviors [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Alcohol and drug use problems [ Time Frame: 6 months ]
    It will be evaluated with the CAGE questionnaire, that consists of 4 items focusing on Cutting down, Annoyance by criticism, Guilty feeling, and Eye-openers and have proved useful in helping to make a diagnosis of alcoholism.Item responses on the CAGE questions are scored 0 for "no" and 1 for "yes" answers, with a higher score being an indication of alcohol problems. A total score of two or greater is considered clinically significant. The questionnaire has been adapted into Spanish.

  2. Panic attacks [ Time Frame: 6 months ]
    It will be assessed with item taken and adapted from the CIDI Screening Scales("Panic or anxiety attacks are sudden, strong feelings of fear or anxiety that reach their peak within a few minutes and are usually accompanied by physical reactions like racing heart, sweating, shortness of breath, feeling faint, or feeling sick to your stomach. People who have panic attacks sometimes feel like they might lose control, go crazy, or suddenly die. With this definition in mind, about how many panic attacks did you have since the onset of COVID-19 outbreak?")

  3. Health-related Quality of Life [ Time Frame: 6 months ]
    It will be assessed with the 5-level version of the EQ-5D-5L, for which a Spanish version is available showing good validity.

  4. Overall Perceived Health [ Time Frame: 6 months ]
    It will be evaluated with a single item assessing general health, ''In general, how would you rate your health'' with response options of ''excellent, very good, good, fair, or poor''), which has shown to have a strong association with negative health outcomes, including mortality [10.1111/j.1525-1497.2005.0291.x]. The Spanish version of the item has provided similar results .

  5. Role limitation [ Time Frame: 6 months ]
    It will be assessed using an adapted version of the Sheehan Disability Scale that assessed impairment separately in each of four role domains: home management/chores, work roles, close personal relationships, and social life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

Inclusion Criteria:

  • 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:

    1. residents in Spain; b) aged 18 years or older; c) with a land-line or mobile telephone

Exclusion Criteria:

  • 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:

    1. unable to understand the survey language; and b) do not provide explicit consent to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556565


Contacts
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Contact: Jordi Alonso, MD (+34) 933 160 760 jalonso@imim.es

Locations
Show Show 18 study locations
Sponsors and Collaborators
Jordi Alonso
Hospital Universitario 12 de Octubre
Instituto de Salud Carlos III
Universitat Pompeu Fabra
Public Health Agency of Barcelona
Jordi Gol i Gurina Foundation
Sistema de Emergencias Médicas de Cataluña (SEM)
Agència de Qualitat i Avaluació Sanitàries
Gerencia de Atención Primaria de Madrid-FIIBAP
Hospital del Mar
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundacion Clinic per a la Recerca Biomédica
Hospital Vall d'Hebron
Hospital Clínico Universitario de Valencia
Hospital General Universitario Gregorio Marañon
Hospital Universitario Principe de Asturias
Hospital El Bierzo
Hospital Universitario Araba
Hospital Universitario Donostia
Hospital de Cruces
Hospital Universitario Torrecárdenas
Parc Sanitari Sant Joan de Déu
Investigators
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Principal Investigator: Jordi Alonso, MD Institut Hospital del Mar d'Investigacions Mèdiques
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Responsible Party: Jordi Alonso, M.D., Ph.D., Coordinator of the Health Services Research Group, Director of the Epidemiology and Public Health Program, Hospital del Mar Research Institute (IMIM)
ClinicalTrials.gov Identifier: NCT04556565    
Other Study ID Numbers: 2020/9203/I
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Alonso, Hospital del Mar Research Institute (IMIM):
COVID-19 outbreak
Health workers
Mental Health
Suicidal thoughts and behaviours
Depression
Anxiety
Post-Traumatic Stress Disorder
General Population
Close contacts
Lockdown
Additional relevant MeSH terms:
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Mental Disorders