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

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ClinicalTrials.gov Identifier: NCT03346239
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Gaze Contingent Music Reward Therapy Drug: Escitalopram Behavioral: Waitlist Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Gaze Contingent Music Reward Therapy
Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
Behavioral: Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.

Active Comparator: Selective Serotonin Reuptake Inhibitors
Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.
Drug: Escitalopram
10-20 mg of Escitalopram
Other Name: Cipralex

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




Primary Outcome Measures :
  1. Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores [ Time Frame: 6 weeks into intervention, 1 week after intervention completion and 3 months 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 Outcome Measures :
  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 and 3 months 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 and 3 months after intervention completion ]
    A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346239


Contacts
Contact: Yair Bar-Haim, PhD +972 3 6405465 yair1@post.tau.ac.il
Contact: Gal Arad, MA +972 528029029 galarad@hotmail.com

Locations
Israel
Tel Aviv University Recruiting
Tel Aviv, Israel
Contact: Gal Arad, MA         
Sponsors and Collaborators
Tel Aviv University
Sheba Medical Center
Investigators
Principal Investigator: Yair Bar-Haim, PhD Tel Aviv University

Responsible Party: Yair Bar-Haim, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT03346239     History of Changes
Other Study ID Numbers: TAUgcMRT
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Phobia, Social
Phobic Disorders
Anxiety Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Dexetimide
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents