Clinical trial NCT04377100: Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses
Official title: Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Healthy Volunteers
Keywords: Coronavirus
Pandemic
Environmental Stress
Avoidance
Healthy Volunteers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-05-06
Enrollment: 2962
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of adult subjects in the U.S.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Functional connectivity of canonical networks
timeFrame: Date of subject participation
Secondary outcomes:
measure: Questionnaire data
timeFrame: Date of subject participation
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Mental Health (NIMH)
state: Maryland
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Maryland Pao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: