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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03437317
Other study ID # PTL-2017.21521
Secondary ID
Status Completed
Phase N/A
First received February 6, 2018
Last updated February 12, 2018
Start date November 1, 2014
Est. completion date December 15, 2016

Study information

Verified date February 2018
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Perceptual Training Study is a series of studies performed with the purpose of identifying a potential avenue for treatment of mood disorders, particularly anxiety-based mood disorders. The underlying theme is that neural representations may be threat-oriented, and may also be generalized to non-threatening cues by means of similarity to threatening representations. These may result in anxiety symptoms from innocuous cues. The idea behind the perceptual training is to create a divorce between the threat representations and cues which should be considered non-threatening, enhancing perceptual acuity and potentially reducing anxiety symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date December 15, 2016
Est. primary completion date December 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Right-handed

- Normal or corrected-to-normal vision

Exclusion Criteria:

- History of a diagnosed neurological or Diagnostic and Statistical Manual of Mental Disorders - IV Axis I disorder

- Currently taking prescribed psychoactive drugs, including anti-depressants or anxiolytics.

- Having electrically, magnetically, or mechanically activated implants (e.g. cardiac pacemakers), due to incompatibility with MRI and MEG systems.

- Pregnancy or suspected pregnancy

Study Design


Intervention

Behavioral:
Perceptual Retraining
Participants viewed faces varying in their expression of anger and were asked to identify if the face was angry or neutral via button press. Participants were provided with feedback if their categorization of the face as neutral or angry was correct. Each participant was assigned 4 levels of angry faces based on their decision point of anger detection in faces. Faces were selected based on the closest existing anger morph to the category boundary; for example, a decision point of 40% anger was closest to the 38% anger face, and so the faces used would have been 17%, 31%, 45%, and 59% anger. For this example, responses of "neutral" to the 31% angry face would be marked as correct, whereas a similar response to the 45% angry face would be incorrect, as it was above their decision point.
Gender Discrimination
Participants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Florida State University Medical College of Wisconsin

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral Evidence for Categorical Perception Changes Participants will be asked to respond if they detected anger in faces varying in their levels of anger expression. This task is used to determine a perceptual bias for threat/anger in faces that is related to increases in social anxiety symptoms, and assess for improvements in the categorization of angry vs. neutral faces. that align with modulations of neural responses (MEG and EEG evidence) indexing perceptual processing of the faces following perceptual retraining. Baseline to Study Completion (14 to 28 Days)
Primary Neural Evidence for Categorical Perception Changes Neural activity will be recorded using EEG and MEG to measure neural processes underpinning categorical perception of anger in faces. Changes in this neural perceptual index will be assessed following perceptual retraining to provide a neural mechanism underpinning behavioral improvements in perceptual categorization and subsequent reductions in anxiety. Baseline to Study Completion (14 to 28 Days)
Secondary Social Anxiety Symptoms - Social Phobia Scale Change in social anxiety symptomatology through perceptual retraining Baseline to Study Completion (14 to 28 Days)
Secondary Social Anxiety Symptoms - Liebowitz Social Anxiety Scale Change in social anxiety symptomatology through perceptual retraining Baseline to Study Completion (14 to 28 Days)
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