Social Anxiety Disorder
Conditions
Brief 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.
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.
Interventions
BEHAVIORALGaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.
DRUGEscitalopram
10-20 mg of Escitalopram
BEHAVIORALWaitlist
Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
Sponsors
Sheba Medical Center
Tel-Aviv Sourasky Medical Center
Tel Aviv University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline - the Social Phobia Inventory scores | At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion | 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. |
| Clinical Global Impression | 6 weeks into intervention, 1 week after intervention completion | A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression | at baseline, one week after end of intervention | Depression levels at pre and posttreatment and their change from baseline were used as moderators for clinical outcome |
| Change from baseline - viewing patterns on threat-neutral face matrices | at baseline, 6 weeks into intervention and one week after end of intervention | 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. |
Countries
Israel
Outcome results
None listed