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

• ClinicalTrials.gov Identifier: NCT04339790
• Recruitment Status: Active, not recruiting
• First Posted: April 9, 2020
• Last Update Posted: November 25, 2020
• Sponsor: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 9, 2020
• Last Update Posted Date: November 25, 2020
• Actual Study Start Date: April 7, 2020
• Estimated Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2020)

NIMH COVID Study survey - adult responses [ Time Frame: Biweekly online responses ]

Thoughts and feelings about mental health impact of COVID-19

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 8, 2020)

DSM XC and KS survey [ Time Frame: Biweekly online self report ]

Ratings on measures of mental health symptoms and distress

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

• Intervention: Not Provided

Study Groups/Cohorts

• 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

Publications *

• 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. Review.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 19, 2020): 10000
• Original Estimated Enrollment (submitted: April 8, 2020): 5000
• Estimated Study Completion Date: April 1, 2022
• Estimated Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04339790
• Other Study ID Numbers: 999920085; 20-M-N085
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
• Study Sponsor: National Institute of Mental Health (NIMH)
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: November 23, 2020