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CompletedNCT02590770Updated Jul 28, 2016

Gaze Contingent Feedback in Social Anxiety Disorder

An interventional study of attention modification and Placebo in Phobia, Social, sponsored by Tel Aviv University. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-07-28.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)

Read the detailed description

The study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

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Conditions studied

  • Phobia, Social

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In context

Phobia, Social

348 studies on the registry are indexed under Phobia, Social; 61 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 320 interventional studies indexed under Phobia, Social.

Browse Phobia, Social studies →

Lead sponsor

Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A signed consent form
  • Men and women between the ages of 18 and 60.
  • Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
  • A minimum of a 1-year duration of SP
  • SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
  • Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion criteria

Exclusion Criteria:

  • Psychotic episode in the past or the present time.
  • Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
  • Another psychotherapeutic treatment during the study.
  • Usage of neuroleptic medication.
  • Change in medication status during the study.
  • Substantial usage of drugs or alcohol in the present time.
  • Poor judgment capacity (i.e., children under 18 and special populations).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    gaze-contingent

    attention modification: participants will receive gaze-contingent feedback according to their viewing patterns

    Behavioral: attention modification

  • Placebo comparator
    non-gaze contingent

    Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns

    Other: Placebo

Interventions

  • Behavioralattention modification

    participants will receive gaze-continent feedback according to their viewing patterns

  • OtherPlacebo

    participants will receive non-gaze-continent feedback unrelated to their viewing patterns

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What researchers measure

Primary outcomes

  1. Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores

    The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability.

    Time frame: post treatment (1 week after treatment completion) and 3-month follow up

Secondary outcomes

  1. Change from baseline - the Social Phobia Inventory scores

    This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68. The SPIN has been used in clinical and nonclinical samples and its psychometric properties have been found to be sound.

    Time frame: post treatment (1 week after treatment completion) and 3-month follow up

Other outcomes

  1. changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis

    a structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.

    Time frame: post treatment (1 week after treatment completion)

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Study locations

1 site
  • Tel-Aviv University
    Tel-Aviv, Israel
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References and documents

Publications

  • Lazarov A, Pine DS, Bar-Haim Y. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Am J Psychiatry. 2017 Jul 1;174(7):649-656. doi: 10.1176/appi.ajp.2016.16080894. Epub 2017 Jan 20. PubMed 28103714 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02590770
Lead sponsor
Tel Aviv University
Responsible party
Yair Bar-Haim (Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University, Tel Aviv University) — Principal investigator
First posted
Oct 29, 2015
Start date
Oct 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Jul 28, 2016

Study contacts

Yair Bar-Haim, PhD
principal investigator · Tel Aviv University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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