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A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Social feedback
Self-referential paradigm
Reward vs. punishment task
Emotional reactivity task
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Social Anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy participants
  • With different levels of social anxiety as measured by the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR; Fresco et al., 2001)
  • Normal or corrected-to-normal vision
  • Compatibility with general MRI requirements

Exclusion Criteria:

- History of neurological or psychiatric diseases

Sites / Locations

  • Tel-Aviv Sourasky medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

social feedback and neuropsychological assessment

Outcomes

Primary Outcome Measures

Change in evaluation of a public performance
Rating of a public performance made on a 0-10 scale before vs. after reception of social feedback
Correlation of social feedback processing with neural indices and anxiety levels
Neural activation and functional connectivity measured during processing of social feedback with different values. Neural activation and functional connectivity measured in fMRI tasks probing elemental neuropsychological processes: 2.A. Processing of self-descriptive traits differing in valence (positive vs. negative) and social domain (power vs. affiliation). 2.B. Response to emotional faces. 2.C. Anticipating and receiving monetary reward vs. loss. 3. Brain functional connectivity obtained during resting-state scans obtained at three time-points: a) before the speech; b) before feedback reception; c) after feedback reception. 4. We will assess the correlation between multiple measurements (i.e. anxiety levels, behavioral indices of speech evaluation bias, and the battery of fMRI tasks) by implementing multivariate and multiparametric statistical models.

Secondary Outcome Measures

Correlation of self-representation processes with neural indices and anxiety levels
Neural activation and functional connectivity measured during processing of social feedback with different values. Neural activation and functional connectivity measured in fMRI tasks probing elemental neuropsychological processes: b1. Processing of self-descriptive traits differing in valence (positive vs. negative) and social domain (power vs. affiliation). b2. Response to emotional faces. b3. Anticipating and receiving monetary reward vs. loss. Brain functional connectivity obtained during resting-state scans obtained at three time-points: before the speech, before feedback reception and after feedback reception. We will assess the correlation between multiple measurements (i.e. anxiety levels, behavioral indices of speech evaluation bias, and the battery of fMRI tasks) by implementing multivariate and multiparametric statistical models.

Full Information

First Posted
May 14, 2018
Last Updated
March 8, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03547713
Brief Title
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
Official Title
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to characterize neuropsychological mechanisms (positive affect, negative affect and self-evaluation) mediating processing of social feedback in people with different levels of social anxiety, by implementing functional and structural MRI.
Detailed Description
Social anxiety (SA) disorder is a relatively widespread emotional disorder which is associated with considerable impairment in social, educational, and occupational functioning (Kessler et al., 2005). This condition is characterized by a debilitating preoccupation with the evaluation of the self by others, ultimately leading to excessive fear and avoidance of interpersonal encounters. As opposed to healthy individuals who typically process social feedback in a positively biased manner, Individuals with high levels of SA tend to evaluate the feedback conveyed by others negatively. Such biases have a profound contribution to the maintenance of social-related concerns (Clark & Wells, 1995). Thus, the overreaching goal of this research is to provide a neuropsychological account of biased processing of social feedback evident in SA. To meet this goal, participants varying in their level of SA are asked to deliver a speech and evaluate it before and after receiving social feedback during an fMRI scan. Additional structural and resting-state fMRI scans, as well as physiological and psychological measures, are obtained throughout the experiment in order to explain individual differences in processing of feedback. fMRI tasks probing basic neuropsychological processes include a self-referential paradigm, wherein participants judge if different traits varying in valence and social domain (power vs. affiliation) are descriptive of them; a reward vs. punishment task, in which participants can win or lose money; and an emotional reactivity task, in which participants view faces with different emotional expressions. The long-term goal of this study is to better delineate both neurobiological and psychological models of SA, as well as to help in directing future neuromodulation-based treatments of mood and anxiety disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
social feedback and neuropsychological assessment
Intervention Type
Behavioral
Intervention Name(s)
Social feedback
Intervention Description
Social feedback regarding performance of a public speech is delivered to participants
Intervention Type
Behavioral
Intervention Name(s)
Self-referential paradigm
Intervention Description
Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)
Intervention Type
Behavioral
Intervention Name(s)
Reward vs. punishment task
Intervention Description
Reception of monetary gains vs. losses
Intervention Type
Behavioral
Intervention Name(s)
Emotional reactivity task
Intervention Description
Exposure to emotional faces vs. shapes
Primary Outcome Measure Information:
Title
Change in evaluation of a public performance
Description
Rating of a public performance made on a 0-10 scale before vs. after reception of social feedback
Time Frame
1 day
Title
Correlation of social feedback processing with neural indices and anxiety levels
Description
Neural activation and functional connectivity measured during processing of social feedback with different values. Neural activation and functional connectivity measured in fMRI tasks probing elemental neuropsychological processes: 2.A. Processing of self-descriptive traits differing in valence (positive vs. negative) and social domain (power vs. affiliation). 2.B. Response to emotional faces. 2.C. Anticipating and receiving monetary reward vs. loss. 3. Brain functional connectivity obtained during resting-state scans obtained at three time-points: a) before the speech; b) before feedback reception; c) after feedback reception. 4. We will assess the correlation between multiple measurements (i.e. anxiety levels, behavioral indices of speech evaluation bias, and the battery of fMRI tasks) by implementing multivariate and multiparametric statistical models.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation of self-representation processes with neural indices and anxiety levels
Description
Neural activation and functional connectivity measured during processing of social feedback with different values. Neural activation and functional connectivity measured in fMRI tasks probing elemental neuropsychological processes: b1. Processing of self-descriptive traits differing in valence (positive vs. negative) and social domain (power vs. affiliation). b2. Response to emotional faces. b3. Anticipating and receiving monetary reward vs. loss. Brain functional connectivity obtained during resting-state scans obtained at three time-points: before the speech, before feedback reception and after feedback reception. We will assess the correlation between multiple measurements (i.e. anxiety levels, behavioral indices of speech evaluation bias, and the battery of fMRI tasks) by implementing multivariate and multiparametric statistical models.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants With different levels of social anxiety as measured by the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR; Fresco et al., 2001) Normal or corrected-to-normal vision Compatibility with general MRI requirements Exclusion Criteria: - History of neurological or psychiatric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talma Hendler, MD, Phd
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky medical center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11513370
Citation
Fresco DM, Coles ME, Heimberg RG, Liebowitz MR, Hami S, Stein MB, Goetz D. The Liebowitz Social Anxiety Scale: a comparison of the psychometric properties of self-report and clinician-administered formats. Psychol Med. 2001 Aug;31(6):1025-35. doi: 10.1017/s0033291701004056.
Results Reference
background
PubMed Identifier
15939839
Citation
Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added].
Results Reference
background
Citation
Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. Social Phobia: Diagnosis, Assessment, and Treatment, 41(68), 00022-3.
Results Reference
background

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A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety

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