Official Title
Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
Brief 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 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.

Completed
Healthy Volunteer
Mood Disorder
Anxiety Disorder
Preexisting Medical Condition
Eligibility Criteria

- 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.

EXCLUSION CRITERIA:

There are no exclusion criteria for this study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States

Joyce Y Chung, M.D., Principal Investigator
National Institute of Mental Health (NIMH)

National Institute of Mental Health (NIMH)
NCT Number
Keywords
Coronavirus
Covid-19
Mental Health
Environmental Stressor
Distress
Natural History
MeSH Terms
COVID-19
Anxiety Disorders
Mood Disorders