Clinical trial NCT05018260: Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety
Official title: Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder (Social Phobia)
Social Anxiety
Social Anxiety Disorder
Keywords: social anxiety
social phobia
attention bias modification
attention control
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

Eligibility 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).

Primary outcomes:
measure: Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores
timeFrame: at baseline, one week after end of intervention
Secondary outcomes:
measure: Change from baseline - the Social Phobia Inventory scores
timeFrame: at baseline, one week after end of intervention
measure: Clinical Global Impression
timeFrame: at baseline, one week after end of intervention
Other outcomes:
measure: Change from baseline -Attention Control Scale- ACS
timeFrame: at baseline, one week after end of intervention
measure: Change from baseline - Patient Health Questionnaire- PHQ9
timeFrame: at baseline, one week after end of intervention
measure: Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.
timeFrame: at baseline, one week after end of intervention
measure: reaction times on the Flanker task, representing attention control
timeFrame: at baseline, one week after end of intervention
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References: