Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic.

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Description

Title: Emotional, Social, Cognitive and Behavioral sequalae of the COVID-19 pandemic 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 pr...

Title: Emotional, Social, Cognitive and Behavioral sequalae of the COVID-19 pandemic 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). Study Population: The sample size will be up to 3000 healthy volunteers and anxiety participants. Participants will be males and females, 18 years and older. They must be English-speaking. In addition to the general population, participants to SNFA studies will also be invited to permit focused analyses of the use of collected pre-pandemic data as predictors of responses to the pandemic. NIMH individuals will include participants who have completed SFNA/NIMH studies (protocols 01-M-0185, 02-M-0321, 03-M-0093, 14-M-0114, 17-M-0042, 17-M-0046, 17-M-0181). Phase: N/A Description of Sites/Facilities Enrolling Participants: The protocol is situated at the NIH Clinical Center with no additional supporting sites. The study itself will be conducted entirely online through a secure study website where consent and study measures will be completed and repeated as specified. Description of Study Intervention: There are no study interventions as this is a descriptive behavioral health survey study, including questionnaires and computer tasks. Study Duration: We will recruit participants for one year. Participant Duration: Study will take approximately 1.5 hours for participants to complete. They may contacted again if additional data need to be collected. Therefore, participants are expected to be 'active' for the duration of the study, i.e., 1 year.

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