Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
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|ClinicalTrials.gov Identifier: NCT03016052|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : November 17, 2017
this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in response to deviations from the embedded contingency in attention bias modification treatment (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and clinical improvement.
***As of September 2017, recruitment of SAD participants has concluded.
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder Generalized Anxiety Disorder||Behavioral: ABMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||October 2017|
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
Participants will be trained with a dot-probe task including angry-neutral faces. The task will be adapted for the oddball paradigm, such that in 80% of trials the probe will appear in place of the neutral face, and in 20% of trials in place of the angry face.
Other Name: attention bias modification
- Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]The 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. 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.
- Change from baseline - The Generalized Anxiety Disorder Severity Scale [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]The Generalized Anxiety Disorder Severity Scale (GADSS) is a 6-item interview assessment that evaluates the severity of each of the DSM-IV symptoms of generalized anxiety disorder. It begins with a target worry list to identify situations that are the focus of worry, and continues with six 5-point-scale items to evaluate levels of generalized anxiety severity.
- Change from baseline - the Social Phobia Inventory scores [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68.
- Change from baseline - the Penn State Worry Questionnaire [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]This is a 16-item self-report measure of the worry dimension of generalized anxiety disorder. the questionnaire is composed of statements, and subjects are request to rate how typical each item is of them, ona 5-point scale ranging from "not typical at all" to "very typical". the PSWQ includes 5 reverse questions.
- Change from baseline - the GAD-7 [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]This is a 7-item self-report measure of generalized anxiety. Each item is rated on a 4-point scale with a possible score of 0-21. Increasing scores indicating increased functional impairment.
- changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis [ Time Frame: 1 week after treatment completion and 2 months after treatment completion ]structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016052
|Tel Aviv University|
|Tel Aviv, Israel, 69978|
|Principal Investigator:||Yair Bar-Haim, PhD||Tel Aviv University|