Back to resultsStatistical Learning as a Predictor of Attention Bias Modification Outcome
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ABM
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring attention-bias modification, statistical learning, social anxiety disorder, treatment outcome
Eligibility Criteria
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
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABM therapy
Arm Description
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03424967
Brief Title
Statistical Learning as a Predictor of Attention Bias Modification Outcome
Official Title
Statistical Learning as a Predictor of Attention Bias Modification Outcome: a Preliminary Study Among Socially Anxious Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
attention-bias modification, statistical learning, social anxiety disorder, treatment outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABM therapy
Arm Type
Experimental
Arm Description
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
Intervention Type
Behavioral
Intervention Name(s)
ABM
Other Intervention Name(s)
attention bias modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores
Description
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
Time Frame
1-2 weeks after treatment completion
Secondary Outcome Measure Information:
Title
The Social Phobia Inventory scores
Description
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.
Time Frame
1-2 weeks after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
6997801
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Statistical Learning as a Predictor of Attention Bias Modification Outcome
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