A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety

March 8, 2020 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel-Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
social feedback and neuropsychological assessment
Social feedback regarding performance of a public speech is delivered to participants
Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)
Reception of monetary gains vs. losses
Exposure to emotional faces vs. shapes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in evaluation of a public performance
Time Frame: 1 day
Rating of a public performance made on a 0-10 scale before vs. after reception of social feedback
1 day
Correlation of social feedback processing with neural indices and anxiety levels
Time Frame: 1 day
  1. Neural activation and functional connectivity measured during processing of social feedback with different values.
  2. 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.

1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of self-representation processes with neural indices and anxiety levels
Time Frame: 1 day
  1. Neural activation and functional connectivity measured during processing of social feedback with different values.
  2. 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.

  3. Brain functional connectivity obtained during resting-state scans obtained at three time-points: before the speech, before feedback reception and 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Talma Hendler, MD, Phd, Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Actual)

October 23, 2018

Study Completion (Actual)

October 23, 2018

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 8, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-18-TH-0082-17-TLV-CTIL

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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