<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/NCT02200003</url>
  </required_header>
  <id_info>
    <org_study_id>1 SC MH 109349-01</org_study_id>
    <nct_id>NCT02200003</nct_id>
  </id_info>
  <brief_title>Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers</brief_title>
  <acronym>ABMT</acronym>
  <official_title>Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hunter College of City University of New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hunter College of City University of New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective,&#xD;
      and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or&#xD;
      exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT&#xD;
      is effective, limiting clinical translation. The proposed research involves an RCT using a&#xD;
      highly sensitive measure of neurocognitive functioning, scalp-recorded event-related&#xD;
      potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety.&#xD;
      Researchers will recruit 90 anxious participants to engage in the study and pursue the&#xD;
      following three specific aims: Aim 1 will examine relations between neural and behavioral&#xD;
      responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat,&#xD;
      threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and&#xD;
      reductions in threat bias and anxiety. Researchers will test whether post-training neural&#xD;
      changes, specified in Aim 2, are associated with reductions in behavioral threat bias and&#xD;
      anxiety severity. Researchers will also explore whether ERP measures of greater attention&#xD;
      capture and/or reduced control of attention to threat at baseline predict treatment response,&#xD;
      helping identify which patients will benefit most from ABMT. Through the innovative&#xD;
      combination of a highly sensitive neurocognitive measure and an RCT design, this study aims&#xD;
      to delineate core neurocognitive responses to threat as mechanisms in the remediation of&#xD;
      anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of&#xD;
      development of more biologically-informed, accessible, and targeted interventions for&#xD;
      anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety disorders are the most common psychiatric diagnosis, affecting as many as 29% of&#xD;
      people during their lifetime. In addition to the devastating personal cost of anxiety, the&#xD;
      yearly economic cost to society has been estimated to be around $46.6 billion in the U.S.&#xD;
      Empirically-based treatments for anxiety have improved in recent years, but barriers to&#xD;
      access, side effects, and high remission rates (~50%) suggest the need for complementary&#xD;
      treatments. Computer-based attention bias modification treatment (ABMT), which is brief,&#xD;
      cost-effective, and easy to administer, targets a key mechanism in pathological anxiety - the&#xD;
      threat bias, or exaggerated attention feared or threatening stimuli. Two decades of research&#xD;
      show that reducing threat bias via computerized ABMT also reduces anxiety severity at levels&#xD;
      comparable to gold-standard treatments. Despite its promise, no randomized clinical trials&#xD;
      (RCTs) have evaluated specific mechanisms underlying ABMT's effects on anxiety, nor&#xD;
      identified predictors of treatment response. Therefore, it remains unclear how and for whom&#xD;
      ABMT is effective, limiting clinical translation. This study is a randomized clinical trial&#xD;
      using a highly sensitive measure of neurocognitive functioning to delineate key mechanisms of&#xD;
      an emerging treatment for anxiety. Specifically, the study will use scalp-recorded&#xD;
      event-related potentials (ERPs) to elucidate neurocognitive processes implicated in attention&#xD;
      bias modification treatment (ABMT) and to predict treatment response. Researchers will&#xD;
      recruit 90 anxious patients to engage in the study and pursue the following three specific&#xD;
      aims: Aim 1 will examine relations between neural and behavioral responses to threat prior to&#xD;
      ABMT. Researchers will test whether greater behavioral threat bias is associated with ERP&#xD;
      responses indicating greater attention capture by threat (larger P1 and P2 ERPs), and reduced&#xD;
      top-down control of attention to threat (smaller N2, N2pc, P3 ERPs). Aim 2 will examine the&#xD;
      effects of ABMT on ERPs to threat, threat bias, and anxiety. Analyses will focus on whether&#xD;
      ABMT relative to placebo training will result in greater reductions in automatic attention&#xD;
      capture and/or controlled attention to threat measured via ERPs. Aim 3 will examine relations&#xD;
      between ERP responses to threat and reductions in threat bias and anxiety. Researchers will&#xD;
      test whether post-training neural changes, specified in Aim 2, will be associated with&#xD;
      reductions in behavioral threat bias and anxiety severity. These predicted relations,together&#xD;
      with those tested in Aim 2a, support the utility of these ERPs as neural markers for the&#xD;
      specific cognitive processes underlying ABMT efficacy. Researchers will also explore whether&#xD;
      ERP measures of greater attention capture and/or reduced control of attention to threat at&#xD;
      baseline predict treatment response, helping identify which patients will benefit most from&#xD;
      ABMT. Through the innovative combination of a highly sensitive neurocognitive measure and an&#xD;
      RCT design, this proposal aims to delineate core neurocognitive responses to threat as&#xD;
      mechanisms in the remediation of anxiety. Confirmation of study hypotheses would, ultimately,&#xD;
      accelerate the pace of development of more biologically-informed, accessible, and targeted&#xD;
      interventions for anxiety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>RCT of Attention Bias Modification</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anxiety severity - immediate post intervention</measure>
    <time_frame>Change in anxiety severity will be assessed five weeks after the baseline assessment</time_frame>
    <description>Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in threat bias</measure>
    <time_frame>Change in threat bias will be assessed five weeks after the baseline assessment</time_frame>
    <description>RT-based measures of facilitated attention to threat (e.g., dot probe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety severity - four-month follow-up</measure>
    <time_frame>Change in anxiety severity will be assessed four months after the post-intervention assessment - a total of five months, one week from the baseline assessment</time_frame>
    <description>Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in neural responses to threat</measure>
    <time_frame>Change in neural responses to threat will be assessed five weeks after the baseline assessment</time_frame>
    <description>Scalp-recorded event-related potential measures (P1, P2, N2, P3) in response to threat stimuli</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behavioral stress reactivity</measure>
    <time_frame>Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment</time_frame>
    <description>Observed and subjective feelings of stress and anxiety during the Trier Social Stress Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physiological measures of stress reactivity</measure>
    <time_frame>Change in physiological stress reactivity will be assessed five weeks after the baseline assessment</time_frame>
    <description>Heart rate and skin conductance during the Trier Social Stress Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Attention Bias Modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>640 Trials (20 minutes) four times over four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Attention bias modification</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>640 Trials (20 minutes) four times over four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>attention bias modification for anxiety</intervention_name>
    <arm_group_label>Attention Bias Modification</arm_group_label>
    <arm_group_label>Sham Attention bias modification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We will recruit ninety adults with moderate to severe symptoms of anxiety between the&#xD;
             ages of 21 and 40, with an equal balance of males and females.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include current or past episodes of disorders that include&#xD;
             psychotic features (e.g., mania, schizophrenia, etc.,), suicidal intent, substance&#xD;
             dependence, changes in pharmacological treatments during the 12 weeks prior to study&#xD;
             entry, any concurrent psychotherapy, and serious medical illness.&#xD;
&#xD;
          -  Other current and/or past Axis I diagnoses will not be excluded, but will be tracked.&#xD;
&#xD;
          -  Given high rates of co-morbidity with anxiety, depressive symptoms will also be&#xD;
             measured to assess impact on findings.&#xD;
&#xD;
          -  To ensure understanding of the protocol, other exclusion criteria include inability to&#xD;
             read, inability to complete assessments (i.e., severely impaired), and lack of English&#xD;
             language comprehension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tracy Dennis, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunter College of The City University of New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hunter College of the City University of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 30, 2018</last_update_submitted>
  <last_update_submitted_qc>July 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hunter College of The City University of New York</investigator_affiliation>
    <investigator_full_name>Tracy Dennis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>attention bias modification, anxiety, event-related potentials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200003
org study id: 1 SC MH 109349-01
nct id: NCT02200003
lead sponsor: 
has dmc: Yes
Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective,
      and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or
      exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT
      is effective, limiting clinical translation. The proposed research involves an RCT using a
      highly sensitive measure of neurocognitive functioning, scalp-recorded event-related
      potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety.
      Researchers will recruit 90 anxious participants to engage in the study and pursue the
      following three specific aims: Aim 1 will examine relations between neural and behavioral
      responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat,
      threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and
      reductions in threat bias and anxiety. Researchers will test whether post-training neural
      changes, specified in Aim 2, are associated with reductions in behavioral threat bias and
      anxiety severity. Researchers will also explore whether ERP measures of greater attention
      capture and/or reduced control of attention to threat at baseline predict treatment response,
      helping identify which patients will benefit most from ABMT. Through the innovative
      combination of a highly sensitive neurocognitive measure and an RCT design, this study aims
      to delineate core neurocognitive responses to threat as mechanisms in the remediation of
      anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of
      development of more biologically-informed, accessible, and targeted interventions for
      anxiety.
Anxiety disorders are the most common psychiatric diagnosis, affecting as many as 29% of
      people during their lifetime. In addition to the devastating personal cost of anxiety, the
      yearly economic cost to society has been estimated to be around $46.6 billion in the U.S.
      Empirically-based treatments for anxiety have improved in recent years, but barriers to
      access, side effects, and high remission rates (~50%) suggest the need for complementary
      treatments. Computer-based attention bias modification treatment (ABMT), which is brief,
      cost-effective, and easy to administer, targets a key mechanism in pathological anxiety - the
      threat bias, or exaggerated attention feared or threatening stimuli. Two decades of research
      show that reducing threat bias via computerized ABMT also reduces anxiety severity at levels
      comparable to gold-standard treatments. Despite its promise, no randomized clinical trials
      (RCTs) have evaluated specific mechanisms underlying ABMT's effects on anxiety, nor
      identified predictors of treatment response. Therefore, it remains unclear how and for whom
      ABMT is effective, limiting clinical translation. This study is a randomized clinical trial
      using a highly sensitive measure of neurocognitive functioning to delineate key mechanisms of
      an emerging treatment for anxiety. Specifically, the study will use scalp-recorded
      event-related potentials (ERPs) to elucidate neurocognitive processes implicated in attention
      bias modification treatment (ABMT) and to predict treatment response. Researchers will
      recruit 90 anxious patients to engage in the study and pursue the following three specific
      aims: Aim 1 will examine relations between neural and behavioral responses to threat prior to
      ABMT. Researchers will test whether greater behavioral threat bias is associated with ERP
      responses indicating greater attention capture by threat (larger P1 and P2 ERPs), and reduced
      top-down control of attention to threat (smaller N2, N2pc, P3 ERPs). Aim 2 will examine the
      effects of ABMT on ERPs to threat, threat bias, and anxiety. Analyses will focus on whether
      ABMT relative to placebo training will result in greater reductions in automatic attention
      capture and/or controlled attention to threat measured via ERPs. Aim 3 will examine relations
      between ERP responses to threat and reductions in threat bias and anxiety. Researchers will
      test whether post-training neural changes, specified in Aim 2, will be associated with
      reductions in behavioral threat bias and anxiety severity. These predicted relations,together
      with those tested in Aim 2a, support the utility of these ERPs as neural markers for the
      specific cognitive processes underlying ABMT efficacy. Researchers will also explore whether
      ERP measures of greater attention capture and/or reduced control of attention to threat at
      baseline predict treatment response, helping identify which patients will benefit most from
      ABMT. Through the innovative combination of a highly sensitive neurocognitive measure and an
      RCT design, this proposal aims to delineate core neurocognitive responses to threat as
      mechanisms in the remediation of anxiety. Confirmation of study hypotheses would, ultimately,
      accelerate the pace of development of more biologically-informed, accessible, and targeted
      interventions for anxiety.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: RCT of Attention Bias Modification
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in anxiety severity - immediate post intervention
time frame: Change in anxiety severity will be assessed five weeks after the baseline assessment
description: Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
measure: Change in threat bias
time frame: Change in threat bias will be assessed five weeks after the baseline assessment
description: RT-based measures of facilitated attention to threat (e.g., dot probe)
measure: Change in anxiety severity - four-month follow-up
time frame: Change in anxiety severity will be assessed four months after the post-intervention assessment - a total of five months, one week from the baseline assessment
description: Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
measure: Change in neural responses to threat
time frame: Change in neural responses to threat will be assessed five weeks after the baseline assessment
description: Scalp-recorded event-related potential measures (P1, P2, N2, P3) in response to threat stimuli
measure: Change in behavioral stress reactivity
time frame: Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment
description: Observed and subjective feelings of stress and anxiety during the Trier Social Stress Test
measure: Change in physiological measures of stress reactivity
time frame: Change in physiological stress reactivity will be assessed five weeks after the baseline assessment
description: Heart rate and skin conductance during the Trier Social Stress Test
arm group label: Attention Bias Modification
arm group type: Experimental
description: 640 Trials (20 minutes) four times over four weeks
arm group label: Sham Attention bias modification
arm group type: Sham Comparator
description: 640 Trials (20 minutes) four times over four weeks
intervention type: Behavioral
intervention name: attention bias modification for anxiety
arm group label: Attention Bias Modification
arm group label: Sham Attention bias modification
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Tracy Dennis, Ph.D.
role: Principal Investigator
affiliation: Hunter College of The City University of New York
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Hunter College of The City University of New York
investigator full name: Tracy Dennis
investigator title: Professor
mesh term: Anxiety Disorders