Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03016052
• Date of registration: 08/01/2017
• Prospective Registration: No
• Primary sponsor: Tel Aviv University
• Public title: Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
• Scientific title: Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study
• Date of first enrolment: May 2016
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03016052
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Yair Bar-Haim, PhD
• Affiliation: Tel Aviv University

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder

Social Anxiety Disorder

Intervention(s)

Behavioral: ABMT

Primary Outcome(s)

Change from baseline - The Generalized Anxiety Disorder Severity Scale [Time Frame: 1 week after treatment completion and 2 months after treatment completion]

Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores [Time Frame: 1 week after treatment completion and 2 months after treatment completion]

Secondary Outcome(s)

Change from baseline - the Social Phobia Inventory scores [Time Frame: 1 week after treatment completion and 2 months after treatment completion]

Change from baseline - the Penn State Worry Questionnaire [Time Frame: 1 week after treatment completion and 2 months after treatment completion]

Change from baseline - the GAD-7 [Time Frame: 1 week after treatment completion and 2 months after treatment completion]

Secondary ID(s)

TAUvMMN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors