Statistical Learning as a Predictor of Attention Bias Modification Outcome

Social Anxiety Disorder Clinical Trial

Official title:

Statistical Learning as a Predictor of Attention Bias Modification Outcome: a Preliminary Study Among Socially Anxious Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424967
• Other study ID #: TAU-SL
• Status: Completed
• Phase: N/A
• First received: February 1, 2018
• Last updated: February 1, 2018
• Start date: August 2, 2016
• Est. completion date: June 12, 2017

Study information

• Verified date: February 2018
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines whether the ability to extract statistical properties from the environment among treatment-seeking patients with social anxiety disorder can predict therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of social anxiety following ABM therapy.

Description:

All participants received 6 sessions of ABM therapy away from threat. At baseline participants also completed a gold standard statistical learning task aimed to assess participants' capacity for the extraction of statistical regularity from the environment. The aim of the study is to determine whether the basic ability to extract rules from the environment at baseline could predict clinical improvement of social anxiety symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• a signed consent form

• a primary diagnosis of social anxiety disorder

• an age of 18-65

Exclusion Criteria:

• any history or present diagnosis of psychosis

• high risk for harm to self or others

• concurrent posttraumatic stress disorder, eating disorder, or bipolar disorder

• a diagnosis of a neurological disorder (i.e., epilepsy, brain injury)

• drug or alcohol misuse

• a pharmacological treatment that is not stabilized in the past 3 months

• any concurrent psychotherapy

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• ABM
Participants are trained with a dot-probe task including angry-neutral faces. In 80% of trials the probe appears in place of the neutral face, and in 20% of trials in place of the angry face.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores	The Liebowitz Social Anxiety Scale is a clinician-rated inventory consisting of 24 items describing socially relevant situations. Each situation is rated in relation to the past week on two sub-scales ranging 0-3: level of fear and level of avoidance experienced in response to these situations. Item scores are summed to a total score ranging 0-144	1-2 weeks after treatment completion
Secondary	The Social Phobia Inventory scores	The Social Phobia Inventory is a self-reported questionnaire comprised of 17 items on a 5-point scale depicting social worries and problems. Participants rate to what extent these situations have bothered them in the past week. Item scores are summed to a total score ranging 0-68.	1-2 weeks after treatment completion