Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04339790|
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : March 21, 2023
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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.
English-speaking adults ages 18 and older
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
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
|Condition or disease|
|Healthy Volunteer Mood Disorder Anxiety Disorder Preexisting Medical Condition|
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 Type :||Observational|
|Actual Enrollment :||3655 participants|
|Official Title:||Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers|
|Actual Study Start Date :||April 7, 2020|
|Actual Primary Completion Date :||May 17, 2021|
|Actual Study Completion Date :||June 2, 2021|
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
- NIMH COVID Study survey - adult responses [ Time Frame: Biweekly online responses ]Thoughts and feelings about mental health impact of COVID-19
- DSM XC and KS survey [ Time Frame: Biweekly online self report ]Ratings on measures of mental health symptoms and distress
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
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.
There are no exclusion criteria for this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339790
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Joyce Y Chung, M.D.||National Institute of Mental Health (NIMH)|
|Responsible Party:||National Institute of Mental Health (NIMH)|
|Other Study ID Numbers:||
|First Posted:||April 9, 2020 Key Record Dates|
|Last Update Posted:||March 21, 2023|
|Last Verified:||February 9, 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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