Clinical trial NCT04187326: Assessing Visual Processing in High Anxiety
Official title: Feed Forward Visual System Function In High Trait Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: visual processing
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-12-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will use a waitlist-control design. A subset of participants will return to complete visual training using the Micro Expression Training Tool (METT). Half of these participants will complete the task at their first follow up visit (approximately six months post scan), and half will complete the task at their second follow up visit (approximately twelve months post scan).

The METT presents videos of micro expressions; participants receive real-time feedback following forced choice emotional identification. The METT includes a brief pre-test, training, and then a post-test. We will collect performance accuracy data. This behavioral task will provide preliminary feasibility data for the development of interventions with visual system targets by helping the investigators determine if the METT is tolerable in individuals with high trait anxiety.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of the Micro Expression Training Task in individuals with high anxiety
timeFrame: six or twelve months post-scan visit
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan School of Medicine
state: Massachusetts
Study officials:
affiliation: Associate Professor
name: Elliot K Edmiston, PhD
role: PRINCIPAL_INVESTIGATOR
References: