Healthy VolunteerNCT04823988
Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic
An observational study of Healthy Volunteer, run by National Institute of Mental Health (NIMH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Healthy Volunteer
- How many people
- 2,086 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of convenience
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18 years of age and older.
- Able to read and write English.
- Able to provide informed consent online using study website.
Who cannot join
- 1. There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic.
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.
Read more
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.
Read the 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).
- Conditions
- Healthy Volunteer
- Keywords
- Social Isolation, virtual, Vaccine, Anxiety, Chronic Covid, Natural History
- Medical subject headings
- Social Isolation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults 18 and over | Adults 18 and over |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study date
Secondary outcomes (1)
Comparison of questionnaire and neuroimaging data with baseline data
The secondary objective is to focus on participants who already completed SNFA studies prior to the pandemic, and for whom we have comprehensive screening data, and resting state MRI scans. These pre-COVID data will be used as predictors of responses to the chronic COVID-19 pandemic.
Measured: Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start13 Apr 2021
- Primary completion1 May 2022
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maryland Pao, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823988
- Sponsor's protocol ID
- 10000376
- Other IDs
- 000376-M
- Status last verified
- May 2025
- First submitted
- 30 Mar 2021
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04823988
- Acronym / sponsor ID
- 10000376
- Conditions
- Healthy Volunteer
- Keywords
- Social Isolation, virtual, Vaccine, Anxiety, Chronic Covid, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,086 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 18 and over | – | –Adults 18 and over |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of convenience
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18 years of age and older.
- Able to read and write English.
- Able to provide informed consent online using study website.
Key exclusion criteria (1 listed)
- 1. There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Online self-report measures
Time frame: Study date
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.
1 secondary outcome
Comparison of questionnaire and neuroimaging data with baseline data
Time frame: Study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryland Pao, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online self-report measures (time frame: Study date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.