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Assessing Visual Processing in High Anxiety (ALPHA)

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ClinicalTrials.gov Identifier: NCT04187326
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kale Edmiston, University of Pittsburgh

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
Anxiety Behavioral: Facial Microexpression Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feed Forward Visual System Function In High Trait Anxiety
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Tolerability of the Micro Expression Training Task in individuals with high anxiety [ Time Frame: six or twelve months post-scan visit ]
    Rates of completion of the behavioral task



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187326


Contacts
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Contact: Kristie Mak, BA 412-383-1973 makk2@upmc.edu
Contact: Elliot K Edmiston, PhD 412-383-8113 edmistonk@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elliot K Edmiston, PhD    412-383-8113    edmistonk@upmc.edu   
Principal Investigator: Elliot K Edmiston, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Elliot K Edmiston, PhD Assistant Professor
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Responsible Party: Kale Edmiston, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04187326    
Other Study ID Numbers: STUDY19010289
1K01MH117290-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kale Edmiston, University of Pittsburgh:
visual processing
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders