Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

NCT03016052 | Completed

• 1 other identifier: TAUvMMN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder; Generalized Anxiety Disorder

Keywords

ABMT; social anxiety; generalized anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from baseline - the Social Phobia Inventory scores

  1 week after treatment completion and 2 months after treatment completion

• Change from baseline - the Penn State Worry Questionnaire

  1 week after treatment completion and 2 months after treatment completion

• Change from baseline - the GAD-7

  1 week after treatment completion and 2 months after treatment completion

Other Outcomes (1)

• changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis

  1 week after treatment completion and 2 months after treatment completion

Study Arms (1)

ABMT

EXPERIMENTAL

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

Interventions

ABMT BEHAVIORAL

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.

Also known as: attention bias modification

ABMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Phobia, Social; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 10, 2017
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)