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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Israel
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
social feedback and neuropsychological assessment
Behavioral: Social feedback
Social feedback regarding performance of a public speech is delivered to participants
Behavioral: Self-referential paradigm
Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)
Behavioral: Reward vs. punishment task
Reception of monetary gains vs. losses
Behavioral: Emotional reactivity task
Exposure to emotional faces vs. shapes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel-Aviv Sourasky Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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