NCT04823988

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,086

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

March 30, 2021

Last Update Submit

May 30, 2025

Conditions

Keywords

Social IsolationvirtualVaccineAnxietyChronic CovidNatural History

Outcome Measures

Primary Outcomes (1)

  • Online self-report measures

    The primary objective is to examine the impact of COVID-19 pandemic and the precarious availability of the vaccine on mental health and cognitive function, in function of a host of factors, including parental situation, history of mental illness, demographic factors, clinical history, and other demographic variables.

    Study date

Secondary Outcomes (1)

  • Comparison of questionnaire and neuroimaging data with baseline data

    Study visit

Study Arms (1)

Adults 18 and over

Adults 18 and over

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of convenience

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • years of age and older.
  • Able to read and write English.
  • Able to provide informed consent online using study website.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Social IsolationAnxiety Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental Disorders

Study Officials

  • Maryland Pao, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

April 13, 2021

Primary Completion

May 1, 2022

Study Completion

April 26, 2023

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations