Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder
• Intervention / Treatment: Behavioral: ABMT

Detailed Description

all participants, suffering from either social anxiety disorder or generalized anxiety disorder, will receive 6 sessions of ABMT, adapted for an oddball paradigm. two of the sessions will also include simultaneous EEG measurement. the goal of the study is to determine the emergence of vMMN in response to trials deviating the embedded contingency and to examine the correlation between vMMN emergence and clinical improvement of anxiety symptoms.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69978
    • Tel Aviv University

Participation Criteria

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
• Men and women between the ages of 18 and 65.
• Meeting a current diagnosis of Social Anxiety Disorder (SP) or Generalized Anxiety Disorder according to the DSM-IV
• SP/GAD as the primary diagnosis: In cases of co-morbidity, SP/GAD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
• Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion Criteria:

• A diagnosis of psychotic or bipolar disorders.
• A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
• Drug or alcohol abuse.
• A pharmacological treatment that is not stabilized in the past 3 months.
• Another psychotherapeutic treatment.
• Change in treatment during the study.
• Poor judgment capacity (i.e., children under 18 and special populations).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABMT; The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.	Behavioral: ABMT; 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 Names: attention bias modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores	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.	1 week after treatment completion and 2 months after treatment completion
Change from baseline - The Generalized Anxiety Disorder Severity Scale	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.	1 week after treatment completion and 2 months after treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - the Social Phobia Inventory scores	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.	1 week after treatment completion and 2 months after treatment completion
Change from baseline - the Penn State Worry Questionnaire	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.	1 week after treatment completion and 2 months after treatment completion
Change from baseline - the GAD-7	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.	1 week after treatment completion and 2 months after treatment completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis	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.	1 week after treatment completion and 2 months after treatment completion

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 8, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: social anxiety; ABMT; generalized anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: TAUvMMN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No