Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04377100 |
| Other study ID # |
999920112 |
| Secondary ID |
20-M-N112 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2020 |
| Est. completion date |
November 19, 2021 |
Study information
| Verified date |
May 18, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
