Healthy VolunteerNCT04339790
Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
An observational study of Healthy Volunteer and Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteer, Mood Disorder, Anxiety Disorder
- How many people
- 3,655 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2020to 2 Jun 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: The study population for the NIMH COVID study will include patient and volunteer participants who have consented for a NIMH study in the past as well as new participants from the general population whorespond to advertisements for the NIMH COVID study but who have not previously been a NIMH studyparticipant. The NIMH COVID study participants may or may not be local to the Metropolitan WashingtonDC area but since the study will be conducted entirely online, this is not relevant.
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
Background:
The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time.
Read more
Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people.
Eligibility:
English-speaking adults ages 18 and older
Design:
This study will be conducted online.
Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password.
Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys.
The surveys will ask about the following:
Age, sex, race, and other sociodemographic data
Mental and medical illness history and treatment
Family medical history
Mobility, self-care, and life activities
Behaviors related to alcohol and substance use disorder
Mental illness symptoms
Psychological distress
Stressors caused by the COVID-19 pandemic.
Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support.
Study website: nimhcovidstudy.ctss.nih.gov
Read the detailed description
Study Description: This protocol leverages existing NIMH studies and participants to accomplish time-sensitive research on the mental health impact of environmental stressors imposed by the COVID-19 pandemic. The study will describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. The utilization of a study website to consent and survey participants online is an efficient and timely way to collect research data during this unique public health crisis.
Objectives: The primary objective is to describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. The secondary objectives are to determine whether existing mental health concerns moderates this relationship and to identify risk and resilience factors among study participants regarding the mental health impact of the COVID-19 pandemic.
Endpoints: The primary endpoints are descriptive data on stressors experienced as a result of the COVID-19 pandemic, and emotional, behavioral, and clinical symptoms. These endpoints will be measured repeatedly using an online platform for up to 6 months. These repeated measures will be combined with previously collected phenotype data on NIMH participants as allowed.
Study Population: The sample size will be up to 10,000 and will include participants 18 years and older of both sexes, any gender, and health status. They must be English-speaking. The study population will include patient and volunteer participants who have consented for a NIMH study in the past as well as new participants from the general population who respond to advertisements for the NIMH COVID study but who have not previously been a NIMH study participant. The NIMH COVID 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.
- Keywords
- Coronavirus, COVID-19, Mental Health, Environmental Stressor, Distress, Natural History
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Coronavirus Infections, COVID-19, Psychological Well-Being
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 |
|---|---|---|
| New study participant | Individuals who respond to study website or advertisements for the study who have not previously been a NIMH study participant | |
| NIMH Study Participant | Individuals who have previously consented for a NIMH study |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIMH COVID Study survey - adult responses
Thoughts and feelings about mental health impact of COVID-19
Measured: Biweekly online responses
Secondary outcomes (1)
DSM XC and KS survey
Ratings on measures of mental health symptoms and distress
Measured: Biweekly online self report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start7 Apr 2020
- Primary completion17 May 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 3,655 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joyce Y Chung, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339790
- Sponsor's protocol ID
- 999920085
- Other IDs
- 20-M-N085
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen S, Gianaros PJ, Manuck SB. A Stage Model of Stress and Disease. Perspect Psychol Sci. 2016 Jul;11(4):456-63. doi: 10.1177/1745691616646305.
PubMed 27474134Kendler KS, Hettema JM, Butera F, Gardner CO, Prescott CA. Life event dimensions of loss, humiliation, entrapment, and danger in the prediction of onsets of major depression and generalized anxiety. Arch Gen Psychiatry. 2003 Aug;60(8):789-96. doi: 10.1001/archpsyc.60.8.789.
PubMed 12912762Gibbons AB, Farmer C, Shaw JS, Chung JY. Examining the factor structure of the DSM-5 Level 1 cross-cutting symptom measure. Int J Methods Psychiatr Res. 2023 Jun;32(2):e1953. doi: 10.1002/mpr.1953. Epub 2022 Nov 1.
PubMed 36318494
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
- ClinicalTrials.gov ID
- NCT04339790
- Acronym / sponsor ID
- 999920085
- Keywords
- Coronavirus, COVID-19, Mental Health, Environmental Stressor, Distress, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,655 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 9 Apr 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:
The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time.
Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people.
Eligibility:
English-speaking adults ages 18 and older
Design:
This study will be conducted online.
Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password.
Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys.
The surveys will ask about the following:
Age, sex, race, and other sociodemographic data
Mental and medical illness history and treatment
Family medical history
Mobility, self-care, and life activities
Behaviors related to alcohol and substance use disorder
Mental illness symptoms
Psychological distress
Stressors caused by the COVID-19 pandemic.
Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support.
Study website: nimhcovidstudy.ctss.nih.gov
Detailed description
Study Description: This protocol leverages existing NIMH studies and participants to accomplish time-sensitive research on the mental health impact of environmental stressors imposed by the COVID-19 pandemic. The study will describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. The utilization of a study website to consent and survey participants online is an efficient and timely way to collect research data during this unique public health crisis.
Objectives: The primary objective is to describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. The secondary objectives are to determine whether existing mental health concerns moderates this relationship and to identify risk and resilience factors among study participants regarding the mental health impact of the COVID-19 pandemic.
Endpoints: The primary endpoints are descriptive data on stressors experienced as a result of the COVID-19 pandemic, and emotional, behavioral, and clinical symptoms. These endpoints will be measured repeatedly using an online platform for up to 6 months. These repeated measures will be combined with previously collected phenotype data on NIMH participants as allowed.
Study Population: The sample size will be up to 10,000 and will include participants 18 years and older of both sexes, any gender, and health status. They must be English-speaking. The study population will include patient and volunteer participants who have consented for a NIMH study in the past as well as new participants from the general population who respond to advertisements for the NIMH COVID study but who have not previously been a NIMH study participant. The NIMH COVID 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New study participant | – | –Individuals who respond to study website or advertisements for the study who have not previously been a NIMH study participant |
| NIMH Study Participant | – | –Individuals who have previously consented for a NIMH study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for the NIMH COVID study will include patient and volunteer participants who have consented for a NIMH study in the past as well as new participants from the general population whorespond to advertisements for the NIMH COVID study but who have not previously been a NIMH studyparticipant. The NIMH COVID study participants may or may not be local to the Metropolitan WashingtonDC area but since the study will be conducted entirely online, this is not relevant.
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.
Primary outcome
NIMH COVID Study survey - adult responses
Time frame: Biweekly online responses
Thoughts and feelings about mental health impact of COVID-19
1 secondary outcome
DSM XC and KS survey
Time frame: Biweekly online self report
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 1 Apr 2026.
- Background: PubMed 27474134Cohen S, Gianaros PJ, Manuck SB. A Stage Model of Stress and Disease. Perspect Psychol Sci. 2016 Jul;11(4):456-63. doi: 10.1177/1745691616646305.
- Background: PubMed 12912762Kendler KS, Hettema JM, Butera F, Gardner CO, Prescott CA. Life event dimensions of loss, humiliation, entrapment, and danger in the prediction of onsets of major depression and generalized anxiety. Arch Gen Psychiatry. 2003 Aug;60(8):789-96. doi: 10.1001/archpsyc.60.8.789.
- Derived from this study: PubMed 36318494Gibbons AB, Farmer C, Shaw JS, Chung JY. Examining the factor structure of the DSM-5 Level 1 cross-cutting symptom measure. Int J Methods Psychiatr Res. 2023 Jun;32(2):e1953. doi: 10.1002/mpr.1953. Epub 2022 Nov 1.
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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.
Joyce Y Chung, 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 and Mood Disorder, 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 1 Apr 2026. 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?
NIMH COVID Study survey - adult responses (time frame: Biweekly online responses). 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 NCT04339790, which also lists 3 linked publications.
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 1 Apr 2026.