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

NCT03346239 | Completed

• 1 other identifier: TAUgcMRT
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline - the Social Phobia Inventory scores

  At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion

• Clinical Global Impression

  6 weeks into intervention, 1 week after intervention completion

Other Outcomes (2)

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

  at baseline, one week after end of intervention

• Change from baseline - viewing patterns on threat-neutral face matrices

  at baseline, 6 weeks into intervention and one week after end of intervention

Study Arms (3)

Gaze Contingent Music Reward Therapy

EXPERIMENTAL

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

Behavioral: Gaze Contingent Music Reward Therapy

Selective Serotonin Reuptake Inhibitors

ACTIVE COMPARATOR

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

Drug: Escitalopram

Waitlist Control

PLACEBO COMPARATOR

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

Behavioral: Waitlist

Interventions

Gaze Contingent Music Reward Therapy BEHAVIORAL

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

Gaze Contingent Music Reward Therapy

Escitalopram DRUG

10-20 mg of Escitalopram

Also known as: Cipralex

Selective Serotonin Reuptake Inhibitors

Waitlist BEHAVIORAL

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

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tel Aviv University: lead
• Sheba Medical Center: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

Location

Related Publications (2)

• Azriel O, Arad G, Tik N, Weiser M, Bloch M, Garber E, Lazarov A, Pine DS, Tavor I, Bar-Haim Y. Neural activation changes following attention bias modification treatment or a selective serotonin reuptake inhibitor for social anxiety disorder. Psychol Med. 2024 Sep 10;54(12):1-13. doi: 10.1017/S0033291724001521. Online ahead of print.

  PMID: 39252484 DERIVED

• Arad G, Azriel O, Pine DS, Lazarov A, Sol O, Weiser M, Garber E, Bloch M, Bar-Haim Y. Attention Bias Modification Treatment Versus a Selective Serotonin Reuptake Inhibitor Or Waiting List Control for Social Anxiety Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2023 May 1;180(5):357-366. doi: 10.1176/appi.ajp.20220533. Epub 2023 Mar 22.

  PMID: 36945823 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Escitalopram; Dexetimide; Waiting Lists

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: July 20, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)