Social Anxiety DisorderNCT03346239
Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
A study testing Gaze Contingent Music Reward Therapy, Escitalopram and Waitlist in people with Social Anxiety Disorder, run by Tel Aviv University at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Gaze Contingent Music Reward Therapy, Escitalopram and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jul 2018to 1 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 DSM-IV.
- 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.
- No current pharmaco-therapy.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Gaze Contingent Music Reward Therapy, Escitalopram, Waitlist
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze Contingent Music Reward TherapyBehavioural
Feedback according to participants' viewing patterns, in order to modify their attention.
EscitalopramDrug
Also called Cipralex
10-20 mg of Escitalopram
WaitlistBehavioural
Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gaze Contingent Music Reward Therapy | Experimental | Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks. Receives: Behavioral: Gaze Contingent Music Reward Therapy |
| Selective Serotonin Reuptake Inhibitors | Active comparator | Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks. Receives: Drug: Escitalopram |
| Waitlist Control | Placebo comparator | Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks into intervention, 1 week after intervention completion
Secondary outcomes (2)
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.
Measured: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion
Clinical Global Impression
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.
Measured: 6 weeks into intervention, 1 week after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Jul 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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 Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Tel-Aviv Sourasky Medical Center
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346239
- Sponsor's protocol ID
- TAUgcMRT
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2017
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avni T, Ben Harush OM, Arad G, Azriel O, Lazarov A, Bar-Haim Y. The impact of ADHD on attentional bias modification outcomes: Evidence from gaze-contingent music reward therapy for social anxiety disorder. Behav Res Ther. 2026 Sep 11;205:105154. doi: 10.1016/j.brat.2026.105154. Online ahead of print.
PubMed 42743597Azriel O, Arad G, Tik N, Weiser M, Bloch M, Garber E, Lazarov A, Pine DS, Tavor I, Bar-Haim Y. Neural activation changes following attention bias modification treatment or a selective serotonin reuptake inhibitor for social anxiety disorder. Psychol Med. 2024 Sep;54(12):3366-3378. doi: 10.1017/S0033291724001521. Epub 2024 Sep 10.
PubMed 39252484Arad G, Azriel O, Pine DS, Lazarov A, Sol O, Weiser M, Garber E, Bloch M, Bar-Haim Y. Attention Bias Modification Treatment Versus a Selective Serotonin Reuptake Inhibitor Or Waiting List Control for Social Anxiety Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2023 May 1;180(5):357-366. doi: 10.1176/appi.ajp.20220533. Epub 2023 Mar 22.
PubMed 36945823
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
- ClinicalTrials.gov ID
- NCT03346239
- Acronym / sponsor ID
- TAUgcMRT
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Tel-Aviv Sourasky Medical Center
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 17 Nov 2017 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gaze Contingent Music Reward Therapy | Experimental | Behavioral: Gaze Contingent Music Reward TherapyParticipants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks. |
| Selective Serotonin Reuptake Inhibitors | Active comparator | Drug: EscitalopramParticipants will receive 10-20 mg of Escitalopram over a course of 12 weeks. |
| Waitlist Control | Placebo comparator | Behavioral: WaitlistParticipants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 DSM-IV.
- 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.
- No current pharmaco-therapy.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Gaze Contingent Music Reward TherapyFeedback according to participants' viewing patterns, in order to modify their attention. | Behavioural | Gaze Contingent Music Reward Therapy |
| EscitalopramAlso: Cipralex10-20 mg of Escitalopram | Drug | Selective Serotonin Reuptake Inhibitors |
| WaitlistParticipants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks. | Behavioural | Waitlist Control |
Primary outcome
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
Time frame: 6 weeks into intervention, 1 week after intervention completion
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.
2 secondary outcomes
Change from baseline - the Social Phobia Inventory scores
Time frame: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion
Clinical Global Impression
Time frame: 6 weeks into intervention, 1 week after intervention completion
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 1 Feb 2022.
- Derived from this study: PubMed 42743597Avni T, Ben Harush OM, Arad G, Azriel O, Lazarov A, Bar-Haim Y. The impact of ADHD on attentional bias modification outcomes: Evidence from gaze-contingent music reward therapy for social anxiety disorder. Behav Res Ther. 2026 Sep 11;205:105154. doi: 10.1016/j.brat.2026.105154. Online ahead of print.
- Derived from this study: PubMed 39252484Azriel O, Arad G, Tik N, Weiser M, Bloch M, Garber E, Lazarov A, Pine DS, Tavor I, Bar-Haim Y. Neural activation changes following attention bias modification treatment or a selective serotonin reuptake inhibitor for social anxiety disorder. Psychol Med. 2024 Sep;54(12):3366-3378. doi: 10.1017/S0033291724001521. Epub 2024 Sep 10.
- Derived from this study: PubMed 36945823Arad G, Azriel O, Pine DS, Lazarov A, Sol O, Weiser M, Garber E, Bloch M, Bar-Haim Y. Attention Bias Modification Treatment Versus a Selective Serotonin Reuptake Inhibitor Or Waiting List Control for Social Anxiety Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2023 May 1;180(5):357-366. doi: 10.1176/appi.ajp.20220533. Epub 2023 Mar 22.
- Individual participant dataSharing planned: No
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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.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze Contingent Music Reward Therapy, Escitalopram and Waitlist in people with Social Anxiety Disorder, run by Tel Aviv University 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 5 inclusion and 7 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 1 Feb 2022. 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. Some participants in this study may receive a placebo. 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 from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores (time frame: 6 weeks into intervention, 1 week after intervention completion). 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 NCT03346239, 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 1 Feb 2022.