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Assessing Visual Processing in High Anxiety (ALPHA)

Primary Purpose

Anxiety

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facial Microexpression Training
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring visual processing

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

6 Month Micro Expression Training Task

12 Month Micro Expression Training Task

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tolerability of the Micro Expression Training Task in individuals with high anxiety
Rates of completion of the behavioral task

Secondary Outcome Measures

Full Information

First Posted
December 3, 2019
Last Updated
May 30, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04187326
Brief Title
Assessing Visual Processing in High Anxiety
Acronym
ALPHA
Official Title
Feed Forward Visual System Function In High Trait Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
visual processing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6 Month Micro Expression Training Task
Arm Type
Experimental
Arm Description
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.
Arm Title
12 Month Micro Expression Training Task
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Facial Microexpression Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability of the Micro Expression Training Task in individuals with high anxiety
Description
Rates of completion of the behavioral task
Time Frame
six or twelve months post-scan visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot K Edmiston, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing Visual Processing in High Anxiety

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