AnxietyNCT04377100
Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses
An observational study of Anxiety and Healthy Volunteers, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Healthy Volunteers
- What is being tested?
- Computer task questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,962 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to 19 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of adult subjects in the U.S.
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
- 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: Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses.
Background:
Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people.
Read more
Objective:
To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19.
Eligibility:
English-speaking adults age 18 and older
Design:
This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks.
Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure.
Participants will complete a set of surveys about the following:
- Sociodemographic data, such age, race, and income
- Education and work status
- Mental and medical illness and treatment
- Family medical history
- Mood
- COVID-19 experience
- Anxiety
- Substance and alcohol use
- Attention control
- Other mental health related topics.
Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it.
It will take about 1 hour to complete the surveys and the task.
About 8 months later, participants will be contacted to repeat the surveys and task.
Compensation is provided.
Read the detailed description
Study Description:
This protocol has 2 goals: (1) Collect data from NIMH research volunteers who already participated in SNFA neuroimaging studies (protocol 02-M-0321,and 14-M-0114) and examine how individual affective, cognitive, and behavioral responses to COVID-19 can be predicted by neural and clinical measures obtained prior to the pandemic. This part-1 concerns only a limited number of adults and represents a unique opportunity to probe critical questions which are difficult to query in empirical experiments or with only retrospective information on stress experience. (2) Collect a large dataset to examine the impact of COVID-19 stressors on motivation pattern (approach/avoidance behavior) in function of anxiety, cognitive and behavioral responses to the pandemic. This part-2 of the protocol is open to any individuals interested in participating. Overall, this is a time-sensitive research on the impact of environmental stressors generated by the COVID-19 pandemic on anxiety, motivation and potential neural mechanisms informed by predictors. Measures collected consist of ratings of stressors related to COVID-19 and more generally, anxiety, cognition, and behavior, including the performance of a motivation-based task (finger-pressing task). and an attention bias task (dot-probe task). This research will use a study website to consent, survey participants online, and tasks.
Objectives:
The primary objective is to examine the relationship of affective, cognitive and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected previously, before COVID-19. This research will identify risk and resilience factors (neural and behavioral) among study participants regarding their responses to COVID-19 crisis. The secondary objective is to gather a large dataset to provide information on how sustained environmental stress affect motivated behavior, particularly with respect to biasing behavior towards avoidance, and how individual factors such as anxiety and cognitive function influence the impact on patterns of motivation. These data are expected to help the interpretation of the role of neuroimaging findings.
Endpoints:
The endpoints are 2-fold: anxiety and motivation pattern responses to COVID-19 stressors (1) in function of clinical phenotype; and (2) in function of endophenotype previously collected using high-resolution 7T fMRI. These endpoints will be measured twice using the same online platform approximately 14-20 months after the start of enrollment.
Study Population:
The sample size will be up to 6000 healthy volunteers and anxiety participants. Participants will be males and females, 18 years and older. They must be English-speaking. The study population will include patient and volunteer participants who have consented for an SFNA study in the past (protocols 01-M-0185, 02-M-0321, 03-M-0093 and 14-M-0114), or NIMH healthy volunteer study (17-M-0181) as well as new participants from the general population who respond to advertisements for the SNFA -COVID study but who have not previously been a NIMH study participant. The SNFA -COVID study study participants may or may not be local to the Metropolitan Washington DC area but since the study will be conducted entirely online, this is not relevant.
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:
The estimated time from study initiation to study completion approximately three years.
Participant Duration:
It is expected that participants will participate in the study for up to 14-20 months with an option to recontact in the future.
- Conditions
- Anxiety, Healthy Volunteers
- Being tested
- Computer task questionnaires
- Keywords
- Coronavirus, Pandemic, Environmental Stress, Avoidance, Healthy Volunteers
- Medical subject headings
- Anxiety Disorders, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer task questionnairesBehavioural
MH COVID-19 Adult, MASQ-SF, STAI, ACS, Hollingshead, DSM XC, PMHC, AUDIT, debriefing questionnaire, and finger-tapping task
| Study group | Role | What they receive |
|---|---|---|
| Adults 18 and over | Adults 18 and over Receives: Behavioral: Computer task questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity of canonical networks
To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.
Measured: Date of subject participation
Secondary outcomes (1)
Questionnaire data
To examine how motivational, affective and cognitive function is impacted by COVID-19, and how these responses are influenced by clinical history among a range of participants from a community sample.
Measured: Date of subject participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start8 May 2020
- Primary completion1 May 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- 2,962 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
- NCT04377100
- Sponsor's protocol ID
- 999920112
- Other IDs
- 20-M-N112
- Status last verified
- May 2025
- First submitted
- 5 May 2020
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will likely submit the de-identified data to a repository but do not have clear plans yet. We will update as we determine the plans.
Publications
Ernst M, Cogo-Moreira H, Desai J, Merke DP. Sexual dimorphism in anxiety is programmed in-utero by sex-steroids: Proof of concept using a disease-model and stress responses to COVID pandemic. Psychiatry Res. 2024 Jan;331:115623. doi: 10.1016/j.psychres.2023.115623. Epub 2023 Nov 27.
PubMed 38064910
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
- Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses.
- ClinicalTrials.gov ID
- NCT04377100
- Acronym / sponsor ID
- 999920112
- Conditions
- Anxiety, Healthy Volunteers
- Keywords
- Coronavirus, Pandemic, Environmental Stress, Avoidance, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,962 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 8 May 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 6 May 2020 (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:
Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people.
Objective:
To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19.
Eligibility:
English-speaking adults age 18 and older
Design:
This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks.
Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure.
Participants will complete a set of surveys about the following:
- Sociodemographic data, such age, race, and income
- Education and work status
- Mental and medical illness and treatment
- Family medical history
- Mood
- COVID-19 experience
- Anxiety
- Substance and alcohol use
- Attention control
- Other mental health related topics.
Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it.
It will take about 1 hour to complete the surveys and the task.
About 8 months later, participants will be contacted to repeat the surveys and task.
Compensation is provided.
Detailed description
Study Description:
This protocol has 2 goals: (1) Collect data from NIMH research volunteers who already participated in SNFA neuroimaging studies (protocol 02-M-0321,and 14-M-0114) and examine how individual affective, cognitive, and behavioral responses to COVID-19 can be predicted by neural and clinical measures obtained prior to the pandemic. This part-1 concerns only a limited number of adults and represents a unique opportunity to probe critical questions which are difficult to query in empirical experiments or with only retrospective information on stress experience. (2) Collect a large dataset to examine the impact of COVID-19 stressors on motivation pattern (approach/avoidance behavior) in function of anxiety, cognitive and behavioral responses to the pandemic. This part-2 of the protocol is open to any individuals interested in participating. Overall, this is a time-sensitive research on the impact of environmental stressors generated by the COVID-19 pandemic on anxiety, motivation and potential neural mechanisms informed by predictors. Measures collected consist of ratings of stressors related to COVID-19 and more generally, anxiety, cognition, and behavior, including the performance of a motivation-based task (finger-pressing task). and an attention bias task (dot-probe task). This research will use a study website to consent, survey participants online, and tasks.
Objectives:
The primary objective is to examine the relationship of affective, cognitive and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected previously, before COVID-19. This research will identify risk and resilience factors (neural and behavioral) among study participants regarding their responses to COVID-19 crisis. The secondary objective is to gather a large dataset to provide information on how sustained environmental stress affect motivated behavior, particularly with respect to biasing behavior towards avoidance, and how individual factors such as anxiety and cognitive function influence the impact on patterns of motivation. These data are expected to help the interpretation of the role of neuroimaging findings.
Endpoints:
The endpoints are 2-fold: anxiety and motivation pattern responses to COVID-19 stressors (1) in function of clinical phenotype; and (2) in function of endophenotype previously collected using high-resolution 7T fMRI. These endpoints will be measured twice using the same online platform approximately 14-20 months after the start of enrollment.
Study Population:
The sample size will be up to 6000 healthy volunteers and anxiety participants. Participants will be males and females, 18 years and older. They must be English-speaking. The study population will include patient and volunteer participants who have consented for an SFNA study in the past (protocols 01-M-0185, 02-M-0321, 03-M-0093 and 14-M-0114), or NIMH healthy volunteer study (17-M-0181) as well as new participants from the general population who respond to advertisements for the SNFA -COVID study but who have not previously been a NIMH study participant. The SNFA -COVID study study participants may or may not be local to the Metropolitan Washington DC area but since the study will be conducted entirely online, this is not relevant.
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:
The estimated time from study initiation to study completion approximately three years.
Participant Duration:
It is expected that participants will participate in the study for up to 14-20 months with an option to recontact in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 18 and over | – | Behavioral: Computer task questionnairesAdults 18 and over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of adult subjects in the U.S.
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)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer task questionnairesMH COVID-19 Adult, MASQ-SF, STAI, ACS, Hollingshead, DSM XC, PMHC, AUDIT, debriefing questionnaire, and finger-tapping task | Behavioural | Adults 18 and over |
Primary outcome
Functional connectivity of canonical networks
Time frame: Date of subject participation
To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.
1 secondary outcome
Questionnaire data
Time frame: Date of subject participation
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.
- Derived from this study: PubMed 38064910Ernst M, Cogo-Moreira H, Desai J, Merke DP. Sexual dimorphism in anxiety is programmed in-utero by sex-steroids: Proof of concept using a disease-model and stress responses to COVID pandemic. Psychiatry Res. 2024 Jan;331:115623. doi: 10.1016/j.psychres.2023.115623. Epub 2023 Nov 27.
- Individual participant dataSharing planned: Undecided. We will likely submit the de-identified data to a repository but do not have clear plans yet. We will update as we determine the plans.
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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 Anxiety and Healthy Volunteers, 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?
Functional connectivity of canonical networks (time frame: Date of subject participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377100, which also lists 1 linked publication.
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.