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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346239
• Other study ID #: TAUgcMRT
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.

Drug:
• Escitalopram
10-20 mg of Escitalopram

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

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (3)

Lead Sponsor	Collaborator
Tel Aviv University	Sheba Medical Center, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change from baseline - viewing patterns on threat-neutral face matrices	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
Primary	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
Secondary	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
Secondary	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