- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547713
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tel-Aviv, Israel, 6423906
- Tel-Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
|
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 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Talma Hendler, MD, Phd, Tel-Aviv Sourasky Medical Center
Publications and helpful links
General Publications
- 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].
- 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.
- Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. Social Phobia: Diagnosis, Assessment, and Treatment, 41(68), 00022-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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