<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03016052</url>
  </required_header>
  <id_info>
    <org_study_id>TAUvMMN</org_study_id>
    <nct_id>NCT03016052</nct_id>
  </id_info>
  <brief_title>Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety</brief_title>
  <official_title>Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel Aviv University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in&#xD;
      response to deviations from the embedded contingency in attention bias modification treatment&#xD;
      (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and&#xD;
      clinical improvement.&#xD;
&#xD;
      ***As of September 2017, recruitment of SAD participants has concluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      all participants, suffering from either social anxiety disorder or generalized anxiety&#xD;
      disorder, will receive 6 sessions of ABMT, adapted for an oddball paradigm. two of the&#xD;
      sessions will also include simultaneous EEG measurement. the goal of the study is to&#xD;
      determine the emergence of vMMN in response to trials deviating the embedded contingency and&#xD;
      to examine the correlation between vMMN emergence and clinical improvement of anxiety&#xD;
      symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline - The Generalized Anxiety Disorder Severity Scale</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - the Social Phobia Inventory scores</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - the Penn State Worry Questionnaire</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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 &quot;not typical at all&quot; to &quot;very typical&quot;. the PSWQ includes 5 reverse questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - the GAD-7</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis</measure>
    <time_frame>1 week after treatment completion and 2 months after treatment completion</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Social Anxiety Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>ABMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ABMT</intervention_name>
    <description>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.</description>
    <arm_group_label>ABMT</arm_group_label>
    <other_name>attention bias modification</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A signed consent form&#xD;
&#xD;
          -  Men and women between the ages of 18 and 65.&#xD;
&#xD;
          -  Meeting a current diagnosis of Social Anxiety Disorder (SP) or Generalized Anxiety&#xD;
             Disorder according to the DSM-IV&#xD;
&#xD;
          -  SP/GAD as the primary diagnosis: In cases of co-morbidity, SP/GAD will be deemed as&#xD;
             the most distressing and clinically significant condition among the co-morbid&#xD;
             disorders.&#xD;
&#xD;
          -  Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are&#xD;
             taking a stable medication for at least 3 months before the beginning of the&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of psychotic or bipolar disorders.&#xD;
&#xD;
          -  A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).&#xD;
&#xD;
          -  Drug or alcohol abuse.&#xD;
&#xD;
          -  A pharmacological treatment that is not stabilized in the past 3 months.&#xD;
&#xD;
          -  Another psychotherapeutic treatment.&#xD;
&#xD;
          -  Change in treatment during the study.&#xD;
&#xD;
          -  Poor judgment capacity (i.e., children under 18 and special populations).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yair Bar-Haim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tel Aviv University</name>
      <address>
        <city>Tel Aviv</city>
        <zip>69978</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Yair Bar-Haim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ABMT</keyword>
  <keyword>social anxiety</keyword>
  <keyword>generalized anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03016052
org study id: TAUvMMN
nct id: NCT03016052
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
time frame: 1 week after treatment completion and 2 months after treatment completion
description: 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.
measure: Change from baseline - The Generalized Anxiety Disorder Severity Scale
time frame: 1 week after treatment completion and 2 months after treatment completion
description: 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.
measure: Change from baseline - the Social Phobia Inventory scores
time frame: 1 week after treatment completion and 2 months after treatment completion
description: 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.
measure: Change from baseline - the Penn State Worry Questionnaire
time frame: 1 week after treatment completion and 2 months after treatment completion
description: 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.
measure: Change from baseline - the GAD-7
time frame: 1 week after treatment completion and 2 months after treatment completion
description: 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.
measure: 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
description: 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.
arm group label: ABMT
arm group type: Experimental
description: The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
intervention type: Behavioral
intervention name: ABMT
description: 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.
arm group label: ABMT
other name: attention bias modification
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yair Bar-Haim, PhD
role: Principal Investigator
affiliation: Tel Aviv University
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Yair Bar-Haim
investigator title: Professor
mesh term: Anxiety Disorders
mesh term: Phobia, Social
sharing ipd: No