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Research project

The MINDCOVID project aims to study the mental health of healthcare workers, COVID-19 patients and their close contacts, and adults from the general Spanish adult population. These represent three potentially vulnerable groups to the negative mental health impact of the COVID-19 pandemic.

The MINDCOVID project aims to provide a comprehensive assessment of the impact on mental health of the current COVID-19 outbreak in Spain. It is proposed as a follow-up project to monitor mental health changes over time in the groups studied.
The project
The project

MINDCOVID focuses its research on providing a comprehensive assessment of the impact of the current Covid-19 pandemic on the mental health of the Spanish population.

Objectives

Main objectives
  1. Assessment of the impact on mental and psychological health of the COVID-19 pandemic in Spain among healthcare workers, COVID-19 patients and their close contacts in isolation or quarantine, and the general adult population.
  2. Identification of risk and protective factors for incidence and persistence of adverse mental health outcomes.
  3. Quantification of the use of available mental health resources.
  4. Quantification and characterization of unmet mental health needs.
Other objectives
  1. Assessment of the potential benefit of using available mental health resources.
  2. Providing a benchmark to understand the impact over time on mental and psychological health related to the COVID-19 pandemic in Spain.

Methodology

MINDCOVID is a multicenter, observational research project focused on three cohorts: healthcare professionals, COVID-19 patients and close contacts of COVID-19 patients, and the general population.
1. Healthcare workers

Study design and population

Participating healthcare professionals came from 18 healthcare institutions in 6 autonomous communities in Spain (Andalusia, Basque Country, Castile and Leon, Catalonia, Madrid, and Valencia). The institutions were selected to reflect the geographic and sociodemographic variability in Spain; most of the participating centers were from regions with a large number of COVID-19 cases. One baseline and three follow-up assessments were conducted through participants' institutional e-mail using the Qualtrics(R) platform.

Baseline assessment

The baseline assessment consisted of anonymous self-reported web-based surveys administered shortly after the first outbreak of COVID-19 in Spain. Data collection was initiated at the time of stabilization of the number of new cases in Spain, but when healthcare institutions-especially hospitals-were under very high demand pressures (May 5 to September 7, 2020).

All workers employed in each participating health institution were invited to participate using the centers' institutional e-mail distribution lists (i.e., the target sample was the census of workers). The survey was not further advertised and no incentives for participation were offered.

The invitation email included an introductory text, an anonymous link to access the web-based survey platform (qualtrics.com). Informed consent was obtained from all participants on the first page of the survey. Up to two reminder emails were sent within 2 to 4 weeks after the initial invitation. At the end of the survey, all participants received a detailed list of local mental health resources, including resources for nearby urgent care for respondents with a suicide attempt in the previous 30 days.

Follow-up assessments

A first follow-up was conducted approximately 2-4 weeks after answering the baseline questionnaire. Data collection was conducted between June 2020 and October 2020. Reminders were sent at 5 and 10 days. The invitation maintained the format used in the baseline questionnaire via web (qualtrics.com).

A second follow-up was performed approximately 4 months after answering the baseline questionnaire. Data collection took place between October 2020 and November 2020. Between 3 to 4 reminders were sent within 2 weeks. The invitation maintained the format used in the baseline questionnaire via the web (qualtrics.com).

A third follow-up was performed approximately 9 months after answering the baseline questionnaire. Data collection took place between March 2021 and April 2021. Four reminders were sent within 2 weeks. The invitation maintained the format used in the baseline questionnaire via web (qualtrics.com).

Participation in the baseline assessment

A total of 9,138 health care workers participated in the baseline survey. The response rate is difficult to estimate since the survey viewing rate (i.e., the proportion of health care workers who opened the invitation e-mail) is unknown, except in one hospital facility (which was 26.4%). When the denominator used to calculate the response rate is the total number of health care workers on the e-mail distribution list or the total number of health care workers employed as provided by hospital representatives, the survey response achieved, adjusted for sample size, was 12.5%. The survey participation rate (i.e., those who agreed to informed consent to participate divided by the total number of people who accessed the first page of the survey with the study information) was 89.0%, and the survey completion rate (i.e., those who completed the survey among those who agreed to participate) was 80.8%.

Participation in follow-up evaluations

At the first follow-up (2-4 weeks), 7,528 health care workers were invited, i.e., 100% of those who answered the baseline questionnaire and gave their e-mail address. A total of 4,959 responses were received, so participation was 66%.

At the second follow-up (4 months), 7,393 health care workers were invited to participate. A total of 4,786 responses were received, obtaining a participation rate of 65%.

Finally, at the third follow-up (9 months), 7,349 health workers were invited to participate. A total of 4,732 responses were received, so participation was 64%.

2. Cases and contacts

Study design and population

A sample of COVID-19 cases and contacts was selected from 10 healthcare institutions from 5 autonomous communities in Spain (Basque Country, Castilla y León, Catalonia, Madrid, and Valencia). The institutions were selected to reflect the geographic and sociodemographic variability in Spain; most of the participating centers were from regions with a large number of COVID-19 cases. One baseline and two follow-up assessments were conducted through participants' institutional e-mail, using the Qualtrics(R) platform, and through telephone interviews, using the GESOP platform.

Each of the participating centers conducted its own recruitment of cases and/or close contacts from COVID-19. For this purpose, a sampling frame was established consisting of the total number of cases or contacts in the center in a given period of time, and a quota of patients to be recruited was established, stratified by age and date of diagnosis or close contact.

The sampling frame was obtained from information from the different local and regional epidemiological services and from the different health services (hospitals and primary care centers) responsible for the identification and management of COVID-19 patients and their close contacts.

Recruitment was carried out both in person and by telephone from the participating health centers. For those recruited in person, a visit to the health center or at discharge was used to inform them about the study and invite them to participate, while those who were invited by telephone were recruited retrospectively, using the available contact information. 

Baseline assessment

The baseline assessment consisted of anonymous self-reported surveys via the web (qualtrics.com) or computer-assisted telephone interviews (CATI), carried out by a specialized company or by persons hired at the centers. Data collection began in July 2020 and ended in March 2021.

Informed consent was again obtained from the participants in the first question of the survey. For those invited via web, 4 reminders were sent within 2 weeks. For those interviewed by telephone, contact was attempted up to 3 times. At the end of the survey, all participants received a detailed list of local mental health resources, including resources for nearby urgent care for respondents with a suicide attempt in the previous 30 days.

Follow-up assessments

In those patients who answered the baseline questionnaire via the web (qualtrics.com), a first follow-up was conducted approximately 2-4 weeks after answering the baseline questionnaire. Data collection was performed between July 2020 and April 2021 using the same web-based format (qualtrics.com). Reminders were sent at 5 and 10 days after the baseline questionnaire.

A second follow-up was performed approximately 7 months after answering the baseline questionnaire. Data collection took place between February 2021 and July 2021. Those who were invited via the web were sent 3 to 4 reminders in 2 weeks, while those who answered via telephone were contacted up to 3 times.

Participation in baseline assessment

A total of 4,185 COVID-19 patients were recruited and 1,009 contacts agreed to participate in the study. Of these, 2,660 responses were finally obtained, of which 1,600 were via the Qualtrics platform and 1,060 were by telephone. Therefore, participation was close to 51%.

Participation in the follow-up evaluations

A total of 1,465 COVID-19 patients and contacts were invited to the first follow-up questionnaire (2-4 weeks), that is, 100% of the people who answered the baseline questionnaire via the Qualtrics platform and accepted the informed consent. A total of 1,091 responses were received, so participation was 74%.

3. General Population

Study design and population

This corresponds to a representative sample of the general adult Spanish population. To select the sample, a double frame telephone sampling was carried out, including a sample of cell phone numbers and another of landlines. A list of cell phone numbers was generated by an automated system, and landline numbers were selected through an internal database developed and maintained by the company, with the aim of ensuring that all Spanish autonomous communities were correctly represented. Up to seven calls were made at different times of the day and several times a week to each selected number. A total of 138,656 numbers were sampled, aiming for representativeness of the sample in terms of age, sex and autonomous community. Verbal informed consent was obtained for data collection from the participants.

 The inclusion criteria were: (1) being over 18 years of age and not institutionalized, (2) being resident in Spain at the start of the study, and (3) having a landline or cell phone. In turn, the exclusion criteria were: (1) having a language barrier to be able to understand the language of the survey and (2) not giving explicit consent to participate.

A baseline and a follow-up assessment was carried out via computer-assisted telephone interview with trained interviewers by a company specializing in research services, IPSOS.

Baseline assessment

The baseline assessment was conducted via computer-assisted telephone interviews between June 1 and June 30, 2020.

Follow-up assessments

A follow-up was conducted approximately 9 months after answering the baseline questionnaire, between February 18 and March 12, 2021.

To incentivize participation in both surveys, at the beginning of each survey, participation in a drawing for 8 state-of-the-art laptops was offered upon completion of both surveys.

Participation baseline assessment

Of the 138,656 numbers sampled, 45,002 were ineligible (business, non-existent number, language barrier, etc.) and 72,428 were of unknown eligibility as they did not respond to any of the calls. The cooperation rate (i.e., the proportion of individuals interviewed among all eligible callers) was 16.5%, with 75% being mobile numbers and 25% being landline numbers, with 3,500 participants in total completing the survey.

Participation in follow-up evaluations

In the follow-up evaluation (9 months), an attempt was made to contact the 3,500 people who answered the baseline questionnaire. A total of 2,000 people participated, so the participation rate was 57%.

Questionnaires, study variables and instruments

The baseline questionnaire is divided into thematic blocks and is made up of Spanish versions of widely accepted and validated instruments in psychological and psychiatric research and practice. Thematic blocks assess relevant mental health outcomes, sociodemographic variables, COVID-19 infection status, and a range of relevant risk and protective factors for adverse mental health related to the COVID-19 pandemic. The following measures were used to screen for adverse mental health outcomes and, hence, to determine the current presence of a probable mental disorder:

  • Major Depressive Disorder (MDD).
    Instrument: PHQ - 8
    Reference: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613. doi:10.1046/j.1525-1497.2001.016009606.x

  • Generalized Anxiety Disorder (GAD)
    Instrument: GAD - 7Reference: Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.10.1092. PMID: 16717171

  • Panic attacks
    Instrument:A WMH-ICS item to indicate number of panic attacks.
    Reference:Kessler RC, Santiago PN, Colpe LJ, et al. Clinical reappraisal of the Composite International Diagnostic Interview Screening Scales (CIDI-SC) in the Army Study to Assess Risk and Resilience in Service members (Army STARRS). Int J Methods Psychiatr Res. 2013;22(4):303-321. doi:10.1002/mpr.1398.

  • Posttraumatic Stress Disorder (PTSD).
    Instrument:PCL - 5
    References: 1. Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Natl Cent PTSD. 2013. doi:10.1037/t02622-000. 2. -Zuromski KL, Ustun B, Hwang I, et al. Developing an optimal short-form of the PTSD Checklist for DSM-5 (PCL-5). Depress Anxiety. 2019;36(9):790-800. doi:10.1002/da.22942

  • Substance Abuse Disorder (SUD).
    Instrument:CAGE-AID
    References: 1.Hinkin CH, Castellon SA, Dickson-Fuhrman E, Daum G, Jaffe J, Jarvik L. Screening for Drug and Alcohol Abuse Among Older Adults Using a Modified Version of the CAGE. Am J Addict. 2001. doi:10.1111/j.1521-0391.2001.tb00521.x 2. López-Maya L, Lina-Manjarrez F, Navarro-Henze S, López LML. Addictions in anesthesiologists: Why have they increased, and should we be concerned? Rev Mex Anesthesiol. 2012.

  • Severe mental disorder
    Instrument: Sheehan Disability Scale
    Reference: Sheehan D V, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11 Suppl 3:89-95. doi:10.1097/00004850-199606003-00015.

  • Previous mental disorders
    Instrument:CIDI 
    Reference: Kessler RC, Üstün TB. The World Mental Health (WMH) Survey Initiative version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI). Int J Methods Psychiatr Res. 2004;13(2):93-121. doi:10.1002/mpr.168.

  • Suicidal ideation and behavior
    Instrument: Columbia Suicide Severity Rating Scale
    Reference: Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults. Am J Psychiatry. 2011;168(12):1266-1277. doi:10.1176/appi.ajp.2011.10111704.

The following items, among others, have been included in the follow-up questionnaires:

  • Optimal structures for a mentally healthy life scale (ad hoc developed)
  • Ucla three-item loneliness scale
  • Social media use items  (ad hoc developed)
  • Brief assessment of family functioning scale (BAFFS)
  • Selected items from the parental stress scale
  • Personal burnout subscale of the copenhagen burnout inventory
  • Selected items from the prodromal questionnaire
  • Obsessing subscale of the obsessive compulsive inventory revised (OCI-R)
  • Adapted prime-md eating disorder items
  • Use of online mental health resources (ad hoc developed)
  • Use of psychotropic drugs
  • Barriers to seek mental health treatment

Ethical considerations

The study complied with the principles established by national and international regulations, including the Declaration of Helsinki and the Code of Ethics. The study protocol was approved by the Medical Research Committee (CEIm) Parc de Salut Mar (2020/9203 / I) and by the corresponding CEIm of all participating centers. The study is registered in ClinicalTrials.gov.

Chronology and study phases

The project