- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424967
Statistical Learning as a Predictor of Attention Bias Modification Outcome
February 1, 2018 updated by: Yair Bar-Haim, Tel Aviv University
Statistical Learning as a Predictor of Attention Bias Modification Outcome: a Preliminary Study Among Socially Anxious Patients
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel Aviv, Israel, 6997801
- Tel Aviv University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ABM therapy
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores
Time Frame: 1-2 weeks after treatment completion
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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
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1-2 weeks after treatment completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Social Phobia Inventory scores
Time Frame: 1-2 weeks after treatment completion
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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.
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1-2 weeks after treatment completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2016
Primary Completion (Actual)
June 12, 2017
Study Completion (Actual)
June 12, 2017
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 1, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
February 7, 2018
Last Update Submitted That Met QC Criteria
February 1, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAU-SL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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