ClinicalTrials.gg
CompletedNCT03346239Updated Feb 1, 2022

Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety

An interventional study of Gaze Contingent Music Reward Therapy and Escitalopram in Social Anxiety Disorder, sponsored by Tel Aviv University. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-01.

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

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Phobia, Social with a site in Israel — 2 open to participants now, 2 under way, none of them phase 3. Phobia, Social · Israel.

Enrollment
2nd of 14
105 · median 75
Started
2018
the only one that year
No phase
12 of 14
2 open now
Registered
8th of 14
by date
Lead sponsor
9 of 14
Tel Aviv University

Among the 14 studies in Phobia, Social with a site in Israel, this one is the 2nd largest by enrollment, is the only one that started in 2018, is one of 12 with no phase, and was the 8th registered.

Phobia, Social

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

Browse Phobia, Social studies →

Open to participants now

2 of the 14 studies in Phobia, Social with a site in Israel are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to determine the clinical efficacy and neuro-cognitive mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with treatment with SSRIs or waitlist control.

Read the detailed description

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with SSRI (Escitelopram) and a waitlist control. A secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. Outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and BOLD signals in MRI measurements. Neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.

03

Conditions studied

  • Social Anxiety Disorder

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A signed consent form
  • Men and women between the ages of 18 and 65.
  • Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the .
  • SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and condition among the co-morbid disorders.
  • No current pharmaco-therapy.

Exclusion criteria

Exclusion Criteria:

  • A diagnosis of psychotic or bipolar disorders.
  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  • Drug or alcohol abuse.
  • Any current pharmacological treatment.
  • Any current psychotherapeutic treatment.
  • Change in treatment during the study.
  • Poor judgment capacity (i.e., children under 18 and special populations).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Gaze Contingent Music Reward Therapy

    Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.

    Behavioral: Gaze Contingent Music Reward Therapy

  • Active comparator
    Selective Serotonin Reuptake Inhibitors

    Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.

    Drug: Escitalopram

  • Placebo comparator
    Waitlist Control

    Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.

    Behavioral: Waitlist

Interventions

  • BehavioralGaze Contingent Music Reward Therapy

    Feedback according to participants' viewing patterns, in order to modify their attention.

  • 10-20 mg of Escitalopram

    Also known as: Cipralex

  • BehavioralWaitlist

    Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.

06

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.

    Time frame: 6 weeks into intervention, 1 week after intervention completion

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.

    Time frame: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion

  2. Clinical Global Impression

    A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.

    Time frame: 6 weeks into intervention, 1 week after intervention completion

Other outcomes

  1. Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression

    Depression levels at pre and posttreatment and their change from baseline were used as moderators for clinical outcome

    Time frame: at baseline, one week after end of intervention

  2. Change from baseline - viewing patterns on threat-neutral face matrices

    gaze patterns, and specifically attention allocation to threat, at pre, mid and posttreatment and their change from baseline were used as moderators for clinical outcome, as well as indicators of target engagement for the GCMRT group. This is done using an established eye-tracking task (Lazarov et al, 2016). Data will also be extracted from the training sessions of GC-MRT participants to evaluate change during treatment.

    Time frame: at baseline, 6 weeks into intervention and one week after end of intervention

07

Study locations

1 site
  • Tel Aviv University
    Tel Aviv, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Dec 2021, 40 months.

Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 40 months is above that.

Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2017
First posted
Nov 17, 2017
StartActual
Jul 20, 2018
Primary completionActual
Dec 1, 2021
CompletionActual
Dec 1, 2021
Last update
Feb 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346239
Responsible party
Yair Bar-Haim (Professor, Tel Aviv University) — Principal investigator
First posted
Nov 17, 2017
Start date
Jul 20, 2018
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Feb 1, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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