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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339790
• Other study ID #: 999920085
• Secondary ID: 20-M-N085
• Status: Completed
• Start date: April 7, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: April 12, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3655
• Est. completion date: June 2, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• COVID-19
• Disease
• Healthy Volunteer
• Mood Disorder
• Mood Disorders
• Preexisting Medical Condition

Locations

Country	Name	City	State
United States	National Institute of Mental Health (NIMH)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIMH COVID Study survey - adult responses	Thoughts and feelings about mental health impact of COVID-19	Biweekly online responses
Secondary	DSM XC and KS survey	Ratings on measures of mental health symptoms and distress	Biweekly online self report