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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339790
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

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


Condition or disease
Healthy Volunteer Mood Disorder Anxiety Disorder Preexisting Medical Condition

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
Estimated Study Start Date : July 7, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Group/Cohort
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



Primary Outcome Measures :
  1. NIMH COVID Study survey - adult responses [ Time Frame: Biweekly online responses ]
    Thoughts and feelings about mental health impact of COVID-19


Secondary Outcome Measures :
  1. DSM XC and KS survey [ Time Frame: Biweekly online self report ]
    Ratings on measures of mental health symptoms and distress



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Joyce Y Chung, M.D. (301) 443-8466 chungj@mail.nih.gov

Locations
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United States, Maryland
National Institute of Mental Health (NIMH) Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Joyce Y Chung, M.D. National Institute of Mental Health (NIMH)
Publications:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT04339790    
Other Study ID Numbers: 999920085
20-M-N085
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: May 18, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Coronavirus
COVID-19
Mental Health
Environmental Stressor
Distress
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders