Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gaze Contingent Music Reward Therapy

Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.

Group Type EXPERIMENTAL

Gaze Contingent Music Reward Therapy

Intervention Type BEHAVIORAL

Feedback according to participants' viewing patterns, in order to modify their attention.

Selective Serotonin Reuptake Inhibitors

Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

10-20 mg of Escitalopram

Waitlist Control

Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.

Group Type PLACEBO_COMPARATOR

Waitlist

Intervention Type BEHAVIORAL

Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.

Interventions

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Gaze Contingent Music Reward Therapy

Feedback according to participants' viewing patterns, in order to modify their attention.

Intervention Type BEHAVIORAL

Escitalopram

10-20 mg of Escitalopram

Intervention Type DRUG

Waitlist

Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cipralex

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No