- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377100
Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses
Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Description:
This protocol has 2 goals: (1) Collect data from NIMH research volunteers who already participated in SNFA neuroimaging studies (protocol 02-M-0321,and 14-M-0114) and examine how individual affective, cognitive, and behavioral responses to COVID-19 can be predicted by neural and clinical measures obtained prior to the pandemic. This part-1 concerns only a limited number of adults and represents a unique opportunity to probe critical questions which are difficult to query in empirical experiments or with only retrospective information on stress experience. (2) Collect a large dataset to examine the impact of COVID-19 stressors on motivation pattern (approach/avoidance behavior) in function of anxiety, cognitive and behavioral responses to the pandemic. This part-2 of the protocol is open to any individuals interested in participating. Overall, this is a time-sensitive research on the impact of environmental stressors generated by the COVID-19 pandemic on anxiety, motivation and potential neural mechanisms informed by predictors. Measures collected consist of ratings of stressors related to COVID-19 and more generally, anxiety, cognition, and behavior, including the performance of a motivation-based task (finger-pressing task). and an attention bias task (dot-probe task). This research will use a study website to consent, survey participants online, and tasks.
Objectives:
The primary objective is to examine the relationship of affective, cognitive and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected previously, before COVID-19. This research will identify risk and resilience factors (neural and behavioral) among study participants regarding their responses to COVID-19 crisis. The secondary objective is to gather a large dataset to provide information on how sustained environmental stress affect motivated behavior, particularly with respect to biasing behavior towards avoidance, and how individual factors such as anxiety and cognitive function influence the impact on patterns of motivation. These data are expected to help the interpretation of the role of neuroimaging findings.
Endpoints:
The endpoints are 2-fold: anxiety and motivation pattern responses to COVID-19 stressors (1) in function of clinical phenotype; and (2) in function of endophenotype previously collected using high-resolution 7T fMRI. These endpoints will be measured twice using the same online platform approximately 14-20 months after the start of enrollment.
Study Population:
The sample size will be up to 6000 healthy volunteers and anxiety participants. Participants will be males and females, 18 years and older. They must be English-speaking. The study population will include patient and volunteer participants who have consented for an SFNA study in the past (protocols 01-M-0185, 02-M-0321, 03-M-0093 and 14-M-0114), or NIMH healthy volunteer study (17-M-0181) as well as new participants from the general population who respond to advertisements for the SNFA -COVID study but who have not previously been a NIMH study participant. The SNFA -COVID study 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.
Description of Sites/Facilities Enrolling Participants:
The protocol is situated at the NIH Clinical Center with no additional supporting sites. The study itself will be conducted entirely online through a secure study website where consent and study measures will be completed and repeated as specified.
Description of Study Intervention:
There are no study interventions as this is a descriptive behavioral health survey study, including questionnaires and computer tasks.
Study Duration:
The estimated time from study initiation to study completion approximately three years.
Participant Duration:
It is expected that participants will participate in the study for up to 14-20 months with an option to recontact in the future.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Mental Health (NIMH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults 18 and over
|
MH COVID-19 Adult, MASQ-SF, STAI, ACS, Hollingshead, DSM XC, PMHC, AUDIT, debriefing questionnaire, and finger-tapping task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional connectivity of canonical networks
Time Frame: Date of subject participation
|
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.
|
Date of subject participation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire data
Time Frame: Date of subject participation
|
To examine how motivational, affective and cognitive function is impacted by COVID-19, and how these responses are influenced by clinical history among a range of participants from a community sample.
|
Date of subject participation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maryland Pao, M.D., National Institute of Mental Health (NIMH)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999920112
- 20-M-N112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Computer task questionnaires
-
Weill Medical College of Cornell UniversityTerminatedObsessive-Compulsive Disorder | Generalized Anxiety Disorder | Social Phobia | Separation Anxiety Disorder | Specific PhobiaUnited States
-
University of California, Los AngelesNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingParkinson DiseaseUnited States
-
Mclean HospitalRecruitingMajor Depressive DisorderUnited States
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Rochester Institute of TechnologyRecruitingBrain ConcussionUnited States
-
Technical University of MunichGerman Research FoundationNot yet recruiting
-
Tel-Aviv Sourasky Medical CenterMcGill University; Tel Aviv UniversityRecruiting
-
National Yang Ming UniversityCompletedTranscranial Magnetic Stimulation | Non-specific Chronic Neck Pain | Neuromuscular Control | Office WorkersTaiwan
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
University of CalgaryCompletedPulmonary Embolism | Clinical Reasoning | Diagnostic Uncertainty | Evidence Based Medicine | Visualization of UncertaintyCanada