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

Primary Purpose

Anxiety Disorders and Symptoms, Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perceptual Retraining
Gender Discrimination
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms focused on measuring Social Anxiety, Threat processing, Magnetoencephalography (MEG)

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Sham Comparator

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Active - MEG

    Control - MEG

    Active - 3 Behavior/EEG

    Active - 1 Behavior/MEG

    Control - 3 Behavior/MEG

    Arm Description

    Participants completed 1 session of 8 Perceptual Retraining blocks following an instructional presentation.

    Participants completed 1 session of 8 blocks of Gender Discrimination Task.

    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.

    Participants completed 1 session of 6 Perceptual Retraining blocks following an instructional presentation.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Social Anxiety Symptoms - Social Phobia Scale
    Change in social anxiety symptomatology through perceptual retraining
    Social Anxiety Symptoms - Liebowitz Social Anxiety Scale
    Change in social anxiety symptomatology through perceptual retraining

    Full Information

    First Posted
    February 6, 2018
    Last Updated
    February 12, 2018
    Sponsor
    Florida State University
    Collaborators
    Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03437317
    Brief Title
    Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence.
    Acronym
    PTL
    Official Title
    Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    December 15, 2016 (Actual)
    Study Completion Date
    December 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Florida State University
    Collaborators
    Medical College of Wisconsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders and Symptoms, Social Anxiety Disorder
    Keywords
    Social Anxiety, Threat processing, Magnetoencephalography (MEG)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomly assigned to either an active training group or a control group. The active participants completed 8 blocks of a perceptual training task, while the control group performed 8 blocks of a gender discrimination task that received the perceptual retraining protocol
    Masking
    Participant
    Masking Description
    Participants were blind to their assigned condition.
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active - MEG
    Arm Type
    Experimental
    Arm Description
    Participants completed 1 session of 8 Perceptual Retraining blocks following an instructional presentation.
    Arm Title
    Control - MEG
    Arm Type
    Sham Comparator
    Arm Description
    Participants completed 1 session of 8 blocks of Gender Discrimination Task.
    Arm Title
    Active - 3 Behavior/EEG
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Active - 1 Behavior/MEG
    Arm Type
    Experimental
    Arm Description
    Participants completed 1 session of 6 Perceptual Retraining blocks following an instructional presentation.
    Arm Title
    Control - 3 Behavior/MEG
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Perceptual Retraining
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Gender Discrimination
    Intervention Description
    Participants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press.
    Primary Outcome Measure Information:
    Title
    Behavioral Evidence for Categorical Perception Changes
    Description
    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.
    Time Frame
    Baseline to Study Completion (14 to 28 Days)
    Title
    Neural Evidence for Categorical Perception Changes
    Description
    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.
    Time Frame
    Baseline to Study Completion (14 to 28 Days)
    Secondary Outcome Measure Information:
    Title
    Social Anxiety Symptoms - Social Phobia Scale
    Description
    Change in social anxiety symptomatology through perceptual retraining
    Time Frame
    Baseline to Study Completion (14 to 28 Days)
    Title
    Social Anxiety Symptoms - Liebowitz Social Anxiety Scale
    Description
    Change in social anxiety symptomatology through perceptual retraining
    Time Frame
    Baseline to Study Completion (14 to 28 Days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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