ALPHA: Assessing Visual Processing in High Anxiety

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04187326
Collaborator
National Institute of Mental Health (NIMH) (NIH)
30
1
2
37
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Facial Microexpression Training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We 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 us determine if the METT is tolerable in individuals with high trait anxiety.We 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 us determine if the METT is tolerable in individuals with high trait anxiety.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feed Forward Visual System Function In High Trait Anxiety
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6 Month Micro Expression Training Task

The Micro Expression Training Task (METT) presents videos of subtle emotional face expressions; participants receive real-time feedback following forced choice emotional identification. The METT includes a brief pre-test, training, and then a post-test.

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.

Experimental: 12 Month Micro Expression Training Task

The Micro Expression Training Task (METT) presents videos of subtle emotional face expressions; participants receive real-time feedback following forced choice emotional identification. The METT includes a brief pre-test, training, and then a post-test. Participants in this group will complete this task twelve month after their first visit.

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.

Outcome Measures

Primary Outcome Measures

  1. Tolerability of the Micro Expression Training Task in individuals with high anxiety [six or twelve months post-scan visit]

    Rates of completion of the behavioral task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Elliot K Edmiston, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kale Edmiston, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04187326
Other Study ID Numbers:
  • STUDY19010289
  • 1K01MH117290-01A1
First Posted:
Dec 5, 2019
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kale Edmiston, Assistant Professor of Psychiatry, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022