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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gaze Contingent Music Reward Therapy | Experimental | Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks. |
|
| Selective Serotonin Reuptake Inhibitors | Active Comparator | Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks. |
|
| Waitlist Control | Placebo Comparator | Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gaze Contingent Music Reward Therapy | Behavioral | Feedback according to participants' viewing patterns, in order to modify their attention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks into intervention, 1 week after intervention completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at baseline, one week after end of intervention |
| Change from baseline - viewing patterns on threat-neutral face matrices |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yair Bar-Haim, PhD | Tel Aviv University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv University | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39252484 | Derived | Azriel 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. | |
| 36945823 |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D003909 | Dexetimide |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Escitalopram | Drug | 10-20 mg of Escitalopram |
|
|
| Waitlist | Behavioral | Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks. |
|
| Clinical Global Impression | A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. | 6 weeks into intervention, 1 week after intervention completion |
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. |
| at baseline, 6 weeks into intervention and one week after end of intervention |
| Arad 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. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |