Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04823988 |
| Other study ID # |
10000376 |
| Secondary ID |
000376-M |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2021 |
| Est. completion date |
April 26, 2023 |
Study information
| Verified date |
May 12, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
...
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).
