Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic
Condition: Healthy Volunteer
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Background:

      COVID-19 has caused a high rate of deaths. The steps taken to control its spread have caused
      social isolation, changes in lifestyle, economic turmoil, and increased work-related stress.
      As a result, there has been a rise in mental and physical health problems. These burdens are
      particularly severe for people with a history of mental illness. Researchers want to learn
      more about the relationship between stressors related to COVID-19 and self-rated measures of
      anxiety and other variables.

      Objective:

      To better understand the impact of this stressful time on people s lives and families. Also,
      to learn the strategies people have been using to deal with the COVID-19 pandemic.

      Eligibility:

      Adults ages 18 and older.

      Design:

      This is an online study.

      Participants will fill out surveys online. The surveys will ask about their mood, anxiety,
      medical history, substance use, and COVID-19 stressors.

      Participants will complete an online task. For the task, they will stare at the center of a
      computer screen. When they see certain images, they will indicate the location of that image
      as quickly as possible.

      It will take about 1.5 hours for participants to complete the surveys and tasks. They may be
      contacted again if additional data is needed.

      Some participants may have taken part in other NIH studies. If so, their new data may be
      linked to their previously collected data.

      ...
    

Detailed description: 
      Study Description:

      The goal of this protocol is to examine individual consequences of the COVID-19 pandemic, in
      the transition resolution phase with the arrival and distribution of the vaccine.
      Specifically, this protocol will capture the 'after-effects' of the pandemic at all levels of
      functioning (cognitive, emotional, social, behavioral), as well as its material impact
      (financial, occupational, educational). Particular attention will be directed to (1) the
      family structure (impact of the pandemic on adults as care-takers) (2) beliefs about and role
      of the introduction of the vaccine, and (3) the changes resulting from the prominent role
      that virtual communication has been playing in our society. Both negative and positive
      consequences will be probed. These effects will be carefully analyzed in function of age,
      gender, SES, race, family structure, psychopathology, and physical health.

      This protocol is a follow-up of protocol 20MN112, titled Impact on Anxiety and Motivation of
      COVID-19 and Predictors of Individual Responses. Protocol 20MN112 was initiated in the early
      days of the pandemic (April 2020) and collects data on individual responses to the active
      phase of the pandemic. As we are conducting interim analyses, we have identified a number of
      questions to query more thoroughly, such as parenting, role of uncertainty, gender
      differences and the cumulative effects of environmental and personal stress. Most
      importantly, this ongoing protocol does not cover responses to the oncoming availability of
      the vaccine, and the potential 'return to normality.'

      The same basic structure as protocol 20MN112 will be used: online questionnaires and
      cognitive task. (1) Questionnaires: We will use questionnaires to reliably gather
      'explanatory' or 'predictive' measures, particularly regarding mental health and belief
      systems. To this aim, we will use well-normed and validated instruments (i.e., ASI, BDI, BRS,
      , DSM XC with substance questions, Hollingshead, Intolerance of Uncertainty scale, MASQ,
      Neuro QoL CFQ, PSS, PROMIS Social Isolation scale, STAI, PSWQ, LSAS, BFI). We will also adapt
      questionnaires to fit the specific focus on the COVID pandemic (Parent questionnaire,
      psychiatric history form, psychiatric history form, vaccine questionnaire, demographic
      questionnaire, COVID clinical mental health history, COVID adult survey, and clinical history
      checklist - medical). (2) Cognitive Tasks: We will continue to use a threat-biased attention
      task (dot-probe task), a modified version of the motivation finger-tapping task, and a
      standard loss aversion task. The finger-tapping task was discontinued with Amendment A. These
      tasks will provide objective measures of the impact of the prolonged effects of the pandemic
      context on cognitive function. This research will use a study website to consent, survey
      participants online, and the task.

      Objectives:

      The primary objective is to examine the impact of the long-standing threat presented by the
      pandemic and its associated societal changes (e.g., social isolation, financial burden) on
      cognitive, emotional, social, behavioral. This research will identify risk and resilience
      factors among study participants and provide clues for interventions tailored to individual
      characteristics (predictive measures).

      Endpoints:

      The endpoints are mental health and attention biases behavioral patterns associated with
      COVID-19 stressors in function of pre-existing clinical phenotype (based on retrospective
      measurements).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample of convenience
      
Keywords: Social Isolation; virtual; Vaccine; Anxiety; Chronic Covid; Natural History