Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence. (PTL)

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder; Anxiety Disorders and Symptoms
• Intervention / Treatment: Behavioral: Perceptual Retraining; Behavioral: Gender Discrimination

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active - MEG; Participants completed 1 session of 8 Perceptual Retraining blocks following an instructional presentation.	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.
Sham Comparator: Control - MEG; Participants completed 1 session of 8 blocks of Gender Discrimination Task.	Behavioral: 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.
Experimental: Active - 3 Behavior/EEG; Participants completed 3 sessions of Perceptual Retraining following an instructional presentation. The first session included 6 blocks of perceptual training, and the second session included 12 blocks of perceptual training. No perceptual training was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart.	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.
Experimental: Active - 1 Behavior/MEG; Participants completed 1 session of 6 Perceptual Retraining blocks following an instructional presentation.	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.
Sham Comparator: Control - 3 Behavior/MEG; Participants completed 3 sessions of a Gender Discrimination Task. The first session included 6 blocks of gender discrimination task, and the second session included 12 blocks of the gender discrimination task. No gender discrimination task was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Anxiety Symptoms - Social Phobia Scale	Change in social anxiety symptomatology through perceptual retraining	Baseline to Study Completion (14 to 28 Days)
Social Anxiety Symptoms - Liebowitz Social Anxiety Scale	Change in social anxiety symptomatology through perceptual retraining	Baseline to Study Completion (14 to 28 Days)

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Social Anxiety; Magnetoencephalography (MEG); Threat processing
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: PTL-2017.21521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No