Healthy Volunteer Clinical Trial
Official title:
Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers
Verified date | April 12, 2023 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Mental Health (NIMH) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
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
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 |
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