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Completed

NCT Number: NCT03346239

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

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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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gaze Contingent Music Reward Therapy

Behavioral

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

Escitalopram

Drug

10-20 mg of Escitalopram

Other names: Cipralex

Waitlist

Behavioral

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

Primary outcomes

  1. Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores

    Time frame: 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 outcomes

  1. Change from baseline - the Social Phobia Inventory scores

    Time frame: 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.

  2. Clinical Global Impression

    Time frame: 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 outcomes

  1. Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression

    Time frame: 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

  2. Change from baseline - viewing patterns on threat-neutral face matrices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2017
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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