MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16,000
- 试验地点
- 18
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
Background
Previous research on infectious disease outbreaks found substantial mental health impact among cases placed under isolation or quarantine, among those working in the various healthcare systems managing the outbreaks, and in the general population. Mental disorders expected to rise during and after viral outbreaks include anxiety disorders, especially post-traumatic stress disorder, as well as depression, and suicidality.
Justification
The magnitude of the ongoing 2019 novel coronavirus disease (COVID-19) pandemic points to the urgent need to quantify mental health impact of the outbreak. Epidemiological research enables rapid health needs assessment to benchmark and monitor the ongoing onset and persistence of adverse mental health outcomes in the population, and to provide situational awareness, i.e., essential information to understand current and midterm mental healthcare needs, plan adequate responses, and allocate appropriate resources. The project is part of an ongoing international effort to collect cross-nationally comparable data on the mental health impact of the COVID-19 pandemic (World Mental Health Surveys).
Hypotheses:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Depression
时间窗: 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).
Post-traumatic stress disorder
时间窗: 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.
Generalized Anxiety Disorder
时间窗: 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).
Suicidal thoughts and behaviors
时间窗: 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.
次要结局
- Role limitation(6 months)
- Panic attacks(6 months)
- Alcohol and drug use problems(6 months)
- Overall Perceived Health(6 months)
- Health-related Quality of Life(6 months)
研究者
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)