Clinical trial NCT03346239: Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Official title: Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
name: Tel-Aviv Sourasky Medical Center
First posted: 2017-11-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
timeFrame: 6 weeks into intervention, 1 week after intervention completion
Secondary outcomes:
measure: Change from baseline - the Social Phobia Inventory scores
timeFrame: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion
measure: Clinical Global Impression
timeFrame: 6 weeks into intervention, 1 week after intervention completion
Other outcomes:
measure: Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression
timeFrame: at baseline, one week after end of intervention
measure: Change from baseline - viewing patterns on threat-neutral face matrices
timeFrame: at baseline, 6 weeks into intervention and one week after end of intervention
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References: