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

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Completed
CT.gov ID
NCT04377100
Collaborator
(none)
2,962
Enrollment
1
Location
1
Arm
18.4
Actual Duration (Months)
161
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: Computer task questionnaires
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2962 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.
Actual Study Start Date :
May 8, 2020
Actual Primary Completion Date :
Apr 9, 2021
Actual Study Completion Date :
Nov 19, 2021

Arms and Interventions

ArmIntervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Patterns of neural connectivity as predictors [Baseline and 14-20 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1National Institute of Mental Health (NIMH)BethesdaMarylandUnited States20892

Sponsors and Collaborators

  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Monique Ernst, M.D., National Institute of Mental Health (NIMH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 19, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institute of Mental Health (NIMH)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021