Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

NCT05018260 | Completed

• 1 other identifier: TAUAttentionControl
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

Conditions

Social Anxiety Disorder (Social Phobia); Social Anxiety; Social Anxiety Disorder

Keywords

social anxiety; social phobia; attention bias modification; attention control

Outcome Measures

Primary Outcomes (1)

• Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores

  The Liebowitz Social Anxiety Scale (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. The minimum and maximum values of the LSAS total score are 0 and 144, respectively, with higher scores mean worse outcome. 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.

  at baseline, one week after end of intervention

Secondary Outcomes (2)

• Change from baseline - the Social Phobia Inventory scores

  at baseline, one week after end of intervention

• Clinical Global Impression

  at baseline, one week after end of intervention

Other Outcomes (4)

• Change from baseline -Attention Control Scale- ACS

  at baseline, one week after end of intervention

• Change from baseline - Patient Health Questionnaire- PHQ9

  at baseline, one week after end of intervention

• Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.

  at baseline, one week after end of intervention

Study Arms (2)

GCMRT

EXPERIMENTAL

Attention bias modification: participants will receive gaze-contingent feedback according to their viewing patterns on disgusted and neutral faces

Behavioral: Attention Bias Modification

attention control

EXPERIMENTAL

Attention control modification: participants will receive gaze-contingent feedback according to their viewing patterns on rounded and sharp geometric shapes

Behavioral: Attention Control

Interventions

Attention Bias Modification BEHAVIORAL

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

GCMRT

Attention Control BEHAVIORAL

Feedback according to participants' viewing patterns, in order to strengthen their attention control

attention 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

Study Sites (1)

Tel Aviv University

Tel Aviv, 55555, Israel

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: particiapants, investigators and outcome assessors are blind to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: May 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)