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

Tel Aviv University

Status: Completed

Conditions: Social Anxiety Disorder

Treatments: Drug: Escitalopram; Behavioral: Waitlist; Behavioral: Gaze Contingent Music Reward Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03346239

TAUgcMRT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

105 participants in 3 patient groups, including a placebo group

Gaze Contingent Music Reward Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Gaze Contingent Music Reward Therapy

Selective Serotonin Reuptake Inhibitors

Active Comparator group

Description:

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

Treatment:

Drug: Escitalopram

Waitlist Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Waitlist