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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01MH117290-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 Month Micro Expression Training Task | Experimental | 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. |
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| 12 Month Micro Expression Training Task | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Microexpression Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the Micro Expression Training Task in Individuals With High Anxiety | Rates of completion of the behavioral task | six or twelve months post-scan visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot K Edmiston, PhD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan School of Medicine | Worcester | Massachusetts | 01655 | United States |
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Participants complete baseline visit and functional MRI scan prior to randomization to trial arms. Only participants with high trait anxiety, as assessed by the Spielberger Trait Anxiety Inventory at baseline visit, are randomized to a trial arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability of the Micro Expression Training Task in Individuals With High Anxiety | Rates of completion of the behavioral task | Participants from a larger study with high trait anxiety were randomized to either a 6 month or 12 month arm. | Posted | Count of Participants | Participants | six or twelve months post-scan visit |
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1 year
AE definition is the same as clinicaltrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Edmiston, Associate Professor of Psychiatry & Behavioral Sciences | UMass Chan School of Medicine | 5088566480 | kale.edmiston@umassmed.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2023 | Aug 15, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 27, 2022 | Aug 15, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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.
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| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. 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. |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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