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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04187326
Other study ID # STUDY19010289
Secondary ID 1K01MH117290-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date April 2024

Study information

Verified date November 2023
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High trait anxiety, a stable personality trait, is a risk factor for psychiatric disorders. Individuals with high trait anxiety have difficulty differentiating safety from threat, including visual information like emotional faces. This study aims to characterize visual system function in high trait anxiety. A portion of this study involves an intervention. For the intervention portion, a subset of participants will be asked to return for a lab visit upon completing the first portion of the study (multimodal magnetic resonance imaging (MRI) scan). During this follow up visit, participants will complete a computer task that involves looking at faces and identifying emotions. Participants will complete this task either six months or twelve months after their MRI scan visit. Results from this research have the potential to inform novel therapies that target the visual system in individuals at risk for the development of psychiatric disorders.


Description:

The purpose of this study is to understand how people with anxious personalities process emotional facial expressions. The intervention portion of this study is part of a larger study. The first portion of this study consists of a screening visit with questionnaires, and a second visit with a magnetic resonance imaging (MRI) scan and short computer tasks. For the intervention portion of this study, a subset of participants will return to the lab for an in-person visit either six or twelve months after their MRI scan. This visit will last approximately two hours. Participants will be asked to complete a computer task where they will be asked to identify emotional face expressions and receive feedback on their performance. They will also complete questionnaires about their mood and emotions. The primary purpose of this research is to gather scientific information about how people with anxiety process social and emotional information.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 23
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Young adults varying continuously in trait anxiety as assessed by the Spielberger State Trait Anxiety Inventory (STAI). - HTA participants with STAI trait scores of =44 Exclusion Criteria: - contraindication to MRI - history of head trauma or loss of consciousness - major medical or neurological illness - current psychiatric medication usage or use in the last three months - alcohol/substance abuse or dependence and/or illicit substance use (excepting cannabis) in the last three months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Facial Microexpression Training
The METT is a well-validated task designed to improve perception of subtle changes in facial expressions, termed microexpressions. Participants with high trait anxiety will return to the lab approximately six months post scan visit to complete this computer-based task. They will receive feedback during the task on their accuracy.

Locations

Country Name City State
United States University of Massachusetts Chan School of Medicine Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Worcester National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability of the Micro Expression Training Task in individuals with high anxiety Rates of completion of the behavioral task six or twelve months post-scan visit
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