- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187326
Assessing Visual Processing in High Anxiety (ALPHA)
Feed Forward Visual System Function In High Trait Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Chan School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
six or twelve months post-scan visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elliot K Edmiston, PhD, Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19010289
- 1K01MH117290-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Facial Microexpression Training
-
University of Alabama, TuscaloosaCompletedAffective Symptoms | EmpathyUnited States
-
University at BuffaloWake Forest University Health Sciences; U.S. Department of Education; Massey... and other collaboratorsCompletedAcquired Brain Injury (Including Stroke)United States, New Zealand, Canada
-
Victoria CollottaActive, not recruiting
-
Facial Concepts, Inc.CompletedSleep Apnea | Primary SnoringUnited States
-
Victoria CollottaActive, not recruiting
-
Revision SkincareCompletedHyperpigmentation | Melasma | Dark SpotsUnited States
-
Brigham and Women's HospitalUnited States Department of DefenseCompleted
-
Kasr El Aini HospitalCompleted