Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016052
• Other study ID #: TAUvMMN
• Status: Completed
• Phase: N/A
• First received: January 8, 2017
• Last updated: November 15, 2017
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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