Social AnxietyNCT03547713
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
A study testing Social feedback, Self-referential paradigm and Reward vs. punishment task in people with Social Anxiety, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Social feedback, Self-referential paradigm and Reward vs. punishment task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Mar 2018to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- History of neurological or psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Social feedback, Self-referential paradigm, Reward vs. punishment task, Emotional reactivity task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social feedbackBehavioural
Social feedback regarding performance of a public speech is delivered to participants
Self-referential paradigmBehavioural
Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)
Reward vs. punishment taskBehavioural
Reception of monetary gains vs. losses
Emotional reactivity taskBehavioural
Exposure to emotional faces vs. shapes
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | social feedback and neuropsychological assessment Receives: Behavioral: Social feedback; Behavioral: Self-referential paradigm; Behavioral: Reward vs. punishment task; Behavioral: Emotional reactivity task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
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.
- 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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start2 Mar 2018
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Talma Hendler, MD, Phd, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547713
- Sponsor's protocol ID
- TASMC-18-TH-0082-17-TLV-CTIL
- Status last verified
- May 2018
- First submitted
- 14 May 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11513370Kessler 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.
PubMed 15939839Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. Social Phobia: Diagnosis, Assessment, and Treatment, 41(68), 00022-3.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
- ClinicalTrials.gov ID
- NCT03547713
- Acronym / sponsor ID
- TASMC-18-TH-0082-17-TLV-CTIL
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Social feedback, Behavioral: Self-referential paradigm, Behavioral: Reward vs. punishment task, Behavioral: Emotional reactivity tasksocial feedback and neuropsychological assessment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of neurological or psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social feedbackSocial feedback regarding performance of a public speech is delivered to participants | Behavioural | Study group |
| Self-referential paradigmExposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation) | Behavioural | Study group |
| Reward vs. punishment taskReception of monetary gains vs. losses | Behavioural | Study group |
| Emotional reactivity taskExposure to emotional faces vs. shapes | Behavioural | Study group |
Primary outcome
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
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 secondary outcome
Correlation of self-representation processes with neural indices and anxiety levels
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 11513370Fresco 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.
- Background: PubMed 15939839Kessler 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.
- BackgroundClark, D. M., & Wells, A. (1995). A cognitive model of social phobia. Social Phobia: Diagnosis, Assessment, and Treatment, 41(68), 00022-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talma Hendler, MD, Phd principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social feedback, Self-referential paradigm and Reward vs. punishment task in people with Social Anxiety, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in evaluation of a public performance (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.