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Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses

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: NCT04377100
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people.

Objective:

To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19.

Eligibility:

English-speaking adults age 18 and older

Design:

This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks.

Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure.

Participants will complete a set of surveys about the following:

  • Sociodemographic data, such age, race, and income
  • Education and work status
  • Mental and medical illness and treatment
  • Family medical history
  • Mood
  • COVID-19 experience
  • Anxiety
  • Substance and alcohol use
  • Attention control
  • Other mental health related topics.

Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it.

It will take about 1 hour to complete the surveys and the task.

About 8 months later, participants will be contacted to repeat the surveys and task.

Compensation is provided.


Condition or disease Intervention/treatment Phase
Anxiety Healthy Volunteers Behavioral: Computer task questionnaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses
Estimated Study Start Date : July 17, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Single arm study
Descriptive behavioral health survey
Behavioral: Computer task questionnaires
MH COVID-19 Adult, MASQ-SF, STAI, ACS, Hollingshead, DSM XC, PMHC, AUDIT, debriefing questionnaire, and finger-tapping task




Primary Outcome Measures :
  1. Patterns of neural connectivity as predictors [ Time Frame: Baseline and 8 months later ]
    To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.



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:   No
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. 18 years of age and older.
  2. Able to read and write English.
  3. 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): NCT04377100


Contacts
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Contact: Morgan Andrews, Ph.D. (301) 594-0642 deborah.roberts@nih.gov

Locations
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United States, Maryland
National Institute of Mental Health (NIMH) Recruiting
Bethesda, Maryland, United States, 20892
Contact: Morgan Andrews, Ph.D.    301-594-0642    deborah.roberts@nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Monique Ernst, M.D. National Institute of Mental Health (NIMH)
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT04377100    
Other Study ID Numbers: 999920112
20-M-N112
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 9, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Coronavirus
Pandemic
Environmental Stress
Avoidance
Healthy Volunteers
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders