Smartphone Sensors to Assess Symptom Relief in Patients With Social Anxiety Disorder Undergoing Treatment

NCT06732999 | Completed

• 1 other identifier: BHQ_SA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine if a digital behavior-based framework, utilizing the BHQ app, can effectively monitor social anxiety symptoms and evaluate the symptom-reducing impact of attentional training for adults (18-65) with social anxiety disorder (SAD), compared to traditional clinical questionnaires and self-reports. The main questions it aims to answer are:

• Complete an initial clinical interview and self-report questionnaires.
• Engage in a computer-based "free-viewing" task for baseline attention assessment using eye tracking.
• Connect to the BHQ app for continuous monitoring throughout the study.
• Undergo attentional training, GC-MRT.
• Complete weekly SPIN assessments.
• Undergo Final evaluation two weeks post-treatment including repeated clinical interviews, self-reports, and the computer-based task to assess changes in attention patterns and symptom reduction.

Conditions

Social Anxiety Disorder (SAD); Attention; Smartphones; Smartphone Application

Keywords

GC-MRT; Social Anxiety Disorder (SAD); Digital Behaviour; Smartphone; Smartphone assesment

Outcome Measures

Primary Outcomes (1)

• The Liebowitz Social Anxiety Scale (LSAS)

  Clinician-rated severity of social anxiety symptoms

  From Pre meeting measurements in week 0 to post training measurements in week 10

Secondary Outcomes (2)

• Threat-related attention bias

  From Pre meeting measurements in week 0 to post training measurements in week 10

• The Social Phobia Inventory (SPIN)

  From Pre meeting measurements in week 0 to post training measurements in week 10

Study Arms (1)

Starting GC-MRT training after randomized allocation of period of time after assesment

EXPERIMENTAL

Gaze-Contingent Music Reward Therapy (GC-MRT) is a treatment method for adults with social anxiety disorder found to be effective in reducing social anxiety in various RCTs. This method includes a computerized cognitive training to redirect threat-related attention patterns. Time period between Pre assessment and start of GC-MRT is randomly assigned (1 week/ 2 weeks/ 3 weeks) to create a multiple baseline design.

Behavioral: Gaze-Contingent Music Reward Therapy (GC-MRT

Interventions

Gaze-Contingent Music Reward Therapy (GC-MRT BEHAVIORAL

Gaze-Contingent Music Reward Therapy (GC-MRT) is a treatment method for adults with social anxiety disorder found to be effective in reducing social anxiety in various RCTs. This method includes a computerized cognitive training to redirect threat-related attention patterns.

Starting GC-MRT training after randomized allocation of period of time after assesment

Eligibility Criteria

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

You may qualify if:

• Normal or corrected vision, without color blindness.
• A primary diagnosis of social anxiety disorder (based on clinician assessment (LSAS), a MINI interview, and an LSAS score above 50).
• Age range of 18-65.
• Ownership of a smartphone that supports the digital monitoring App.

You may not qualify if:

• Prior experience with GC-MRT.
• A current diagnosis of post-traumatic stress disorder (PTSD).
• A current or past diagnosis of psychosis or bipolar disorder.
• Neurological disorder (e.g., epilepsy, brain injury).
• Severe suicidal ideation.
• Substance or alcohol addiction.
• Concurrent treatment (pharmacological or psychosocial).
• Pregnancy.
• Insufficient Hebrew proficiency (unable to complete a clinical interview and/or self-report symptoms and/or perform cognitive tasks).

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, Professor

  School of Psychological Sciences and Sagol School of Neuroscience, Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to three groups with varying intervals between the pre-assessment and the start of treatment, following a multiple-baseline design (Group A - 1 week; Group B - 2 weeks; Group C - 3 weeks). All participants will receive the same treatment (GC-MRT).

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 13, 2024
• Study Start: November 24, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)