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NCT Number: NCT03016052

Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 69978, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: attention bias modification

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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