Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers

NCT04339790 | Completed

• 2 other identifiers: 99992008520-M-N085
• Study Type: observational
• Target: 3,655
• Locations: 1 country
• Sites: 1

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

Conditions

Mood Disorder; Anxiety Disorder; Healthy Volunteer; Preexisting Medical Condition

Keywords

Coronavirus; COVID-19; Mental Health; Environmental Stressor; Distress; Natural History

Outcome Measures

Primary Outcomes (1)

• NIMH COVID Study survey - adult responses

  Thoughts and feelings about mental health impact of COVID-19

  Biweekly online responses

Secondary Outcomes (1)

• DSM XC and KS survey

  Biweekly online self report

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• years of age and older.
• Able to read and write English.
• Able to provide informed consent online using study website.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 27474134 BACKGROUND

• Kendler 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.

  PMID: 12912762 BACKGROUND

• Gibbons 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.

  PMID: 36318494 DERIVED

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders; Coronavirus Infections; COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior

Study Officials

• Joyce Y Chung, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 9, 2020
• Study Start: April 7, 2020
• Primary Completion: May 17, 2021
• Study Completion: June 2, 2021
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)