Phobia, SocialNCT02590770
Gaze Contingent Feedback in Social Anxiety Disorder
A study testing attention modification in people with Phobia, Social, run by Tel Aviv University at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Phobia, Social
- What is being tested?
- attention modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Jul 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaze Contingent Feedback in Treatment of SAD
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.
- Conditions
- Phobia, Social
- Being tested
- attention modification, Placebo
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attention modificationBehavioural
participants will receive gaze-continent feedback according to their viewing patterns
PlaceboOther
participants will receive non-gaze-continent feedback unrelated to their viewing patterns
| Study group | Role | What they receive |
|---|---|---|
| gaze-contingent | Active comparator | attention modification: participants will receive gaze-contingent feedback according to their viewing patterns Receives: Behavioral: attention modification |
| non-gaze contingent | Placebo comparator | Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns Receives: Other: Placebo |
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. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability.
Measured: 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.
Measured: post treatment (1 week after treatment completion) and 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phobia, SocialStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- 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
- NCT02590770
- Sponsor's protocol ID
- TAUSAD
- Status last verified
- Jul 2016
- First submitted
- 27 Oct 2015
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- 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 42743597Lazarov 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze Contingent Feedback in Treatment of SAD
- ClinicalTrials.gov ID
- NCT02590770
- Acronym / sponsor ID
- TAUSAD
- Conditions
- Phobia, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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 whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gaze-contingent | Active comparator | Behavioral: attention modificationattention modification: participants will receive gaze-contingent feedback according to their viewing patterns |
| non-gaze contingent | Placebo comparator | Other: PlaceboPlacebo: participants will receive non-gaze-contingent feedback according to their viewing patterns |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| attention modificationparticipants will receive gaze-continent feedback according to their viewing patterns | Behavioural | gaze-contingent |
| Placeboparticipants will receive non-gaze-continent feedback unrelated to their viewing patterns | Other | non-gaze contingent |
Primary outcome
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
Time frame: post treatment (1 week after treatment completion) and 3-month follow up
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.
1 secondary outcome
Change from baseline - the Social Phobia Inventory scores
Time frame: post treatment (1 week after treatment completion) and 3-month follow up
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 28 Jul 2016.
- 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 28103714Lazarov 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.
Related trials for Phobia, Social
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Social Anxiety Disorder, Social Fear
Active, not recruiting
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Autism Spectrum Disorder, Autism
Active, not recruiting
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Body Dysmorphic Disorder, Eating Disorders
RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
Social Anxiety Disorder (SAD)
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 attention modification in people with Phobia, Social, 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 6 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 28 Jul 2016. 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: post treatment (1 week after treatment completion) and 3-month follow up). 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 NCT02590770, which also lists 2 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 28 Jul 2016.