NCT03547713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2018

Completed
Last Updated

March 11, 2020

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

May 14, 2018

Last Update Submit

March 8, 2020

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (2)

  • 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

    1 day

  • Correlation of social feedback processing with neural indices and anxiety levels

    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 Outcomes (1)

  • Correlation of self-representation processes with neural indices and anxiety levels

    1 day

Study Arms (1)

Study group

EXPERIMENTAL

social feedback and neuropsychological assessment

Behavioral: Social feedbackBehavioral: Self-referential paradigmBehavioral: Reward vs. punishment taskBehavioral: Emotional reactivity task

Interventions

Social feedbackBEHAVIORAL

Social feedback regarding performance of a public speech is delivered to participants

Study group
Self-referential paradigmBEHAVIORAL

Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)

Study group
Reward vs. punishment taskBEHAVIORAL

Reception of monetary gains vs. losses

Study group
Emotional reactivity taskBEHAVIORAL

Exposure to emotional faces vs. shapes

Study group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- History of neurological or psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky medical center

Tel Aviv, 6423906, Israel

Location

Related Publications (3)

  • 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.

    PMID: 11513370BACKGROUND

  • 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.

    PMID: 15939839BACKGROUND

  • Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. Social Phobia: Diagnosis, Assessment, and Treatment, 41(68), 00022-3.

    BACKGROUND

Study Officials

  • Talma Hendler, MD, Phd

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 6, 2018

Study Start

March 2, 2018

Primary Completion

October 23, 2018

Study Completion

October 23, 2018

Last Updated

March 11, 2020

Record last verified: 2018-05

Locations

IL(1)