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Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03016052
First Posted: January 10, 2017
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University
  Purpose

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 Intervention
Social Anxiety Disorder Generalized Anxiety Disorder Behavioral: ABMT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study

Resource links provided by NLM:


Further study details as provided by Yair Bar-Haim, Tel Aviv University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 80
Actual Study Start Date: May 2016
Study Completion Date: October 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: attention bias modification

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Israel
Tel Aviv University
Tel Aviv, Israel, 69978
Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Yair Bar-Haim, PhD Tel Aviv University
  More Information

Responsible Party: Yair Bar-Haim, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT03016052     History of Changes
Other Study ID Numbers: TAUvMMN
First Submitted: January 8, 2017
First Posted: January 10, 2017
Last Update Posted: November 16, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yair Bar-Haim, Tel Aviv University:
ABMT
social anxiety
generalized anxiety

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders