<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/NCT01730625</url>
  </required_header>
  <id_info>
    <org_study_id>ABMT-RCT</org_study_id>
    <nct_id>NCT01730625</nct_id>
  </id_info>
  <brief_title>Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial</brief_title>
  <official_title>Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial</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>
      The development of easily disseminated and efficacious treatment of psychiatric disorder is&#xD;
      an important goal for translational neuroscience research. To that end, Attention Bias&#xD;
      Modification Treatment (ABMT), a novel intervention targeting threat-related attention&#xD;
      biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined&#xD;
      whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has&#xD;
      examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the&#xD;
      treatment of choice for anxiety disorders. Studying this question in youth is particularly&#xD;
      important given that the onset of most anxiety disorders is during childhood, and early&#xD;
      interventions may reduce long-term affliction. The current study is the first randomized&#xD;
      control trial designed to examine the augmenting effects of ABMT on CBT among clinically&#xD;
      anxious youth.&#xD;
&#xD;
      The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape&#xD;
      anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic&#xD;
      tool. During training, the target location is systematically manipulated to increase the&#xD;
      proportion of targets appearing at the location opposite the patient's bias. For example, in&#xD;
      a training protocol intended to reduce threat bias, targets would appear more frequently at&#xD;
      locations of neutral than threat stimuli.&#xD;
&#xD;
      Although CBT is an effective treatment for anxiety disorders, combining it with other&#xD;
      treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two&#xD;
      interventions targeting different aspects of anxiety and therefore could potentially&#xD;
      complement one another. While CBT modifies explicit and voluntary attention through verbal&#xD;
      intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT,&#xD;
      the integration of the two treatments can have few significant benefits: First, it will&#xD;
      combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce&#xD;
      the number of patients who respond poorly to CBT or do not respond at all. Second,&#xD;
      computer-based training of attention may be more acceptable than traditional in-person&#xD;
      therapy formats for some children and adolescents and can raise the cooperation in therapy.&#xD;
      Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered&#xD;
      consistently&#xD;
&#xD;
      The current study was designed to examine the ABMT augmentation effects on CBT for children&#xD;
      with anxiety disorders. This study is the first randomized control trial in clinically&#xD;
      anxious youth. Participants were randomly assigned to one of three conditions: 1. Training&#xD;
      condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT&#xD;
      alone). We hypothesize that participants in the training condition will show the greatest&#xD;
      improvement in anxiety symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in frequency of anxiety symptoms (based on ADIS)</measure>
    <time_frame>Change from baseline to up to 3 weeks after last treatment session</time_frame>
    <description>Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in severity of anxiety symptoms (based on ADIS)</measure>
    <time_frame>Change from baseline to up to 3 weeks after last treatment session</time_frame>
    <description>ADIS interview (see above)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SCARED parent/child</measure>
    <time_frame>pre and post treatment</time_frame>
    <description>The SCARED-R is 41- items parent and child reported questionnaire, measuring DSM-IV defined anxiety disorder symptoms in children. The scale measures symptoms of separation anxiety, generalized anxiety disorder, panic disorder, social phobia and school phobia. SCARED-R total and subscale scores can be obtained by summing across relevant items. The SCARED-R is a valid and reliable child anxiety instrument {Muris, 2001 #2;Muris, 2001 #3;Muris, 1999 #4} that has been extensively used in clinical and research contexts in Israel {Eldar, 2012 #32}.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>ABMT + CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBT and ABMT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT Alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>CBT alone (compare/control group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABMT placebo + CBT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ABMT placebo training and CBT</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy for anxiety</intervention_name>
    <arm_group_label>ABMT + CBT</arm_group_label>
    <arm_group_label>ABMT placebo + CBT</arm_group_label>
    <arm_group_label>CBT Alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Bias Modification Treatment</intervention_name>
    <arm_group_label>ABMT + CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children ranging in age from 6 - 18 year&#xD;
&#xD;
          2. At least one clinical diagnoses of either separation anxiety disorder (SAD), social&#xD;
             phobia (SP), specific phobia, or generalized anxiety disorder (GAD) (American&#xD;
             Psychiatric Association [APA], 1994)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime history of psychosis&#xD;
&#xD;
          2. Child's inability to comply to CBT&#xD;
&#xD;
          3. Diagnosis of post traumatic stress disorder (PTSD), diagnosis of obsessive compulsive&#xD;
             disorder (OCD), or selective mutism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yair Bar-Haim, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tomer Shechner, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Tel Aviv University/Schneider children medical center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan Apter, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Tel Aviv University/Schnider children medical center</affiliation>
  </overall_official>
  <reference>
    <citation>Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.</citation>
    <PMID>22423353</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</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>Prof. Yair Bar-Haim, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Attention bias modification treatment (ABMT)</keyword>
  <keyword>Attention biases</keyword>
  <keyword>Anxious children</keyword>
  <keyword>Cognitive Behavioral Therapy (CBT)</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/NCT01730625
org study id: ABMT-RCT
nct id: NCT01730625
lead sponsor: 
has dmc: No
The development of easily disseminated and efficacious treatment of psychiatric disorder is
      an important goal for translational neuroscience research. To that end, Attention Bias
      Modification Treatment (ABMT), a novel intervention targeting threat-related attention
      biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined
      whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has
      examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the
      treatment of choice for anxiety disorders. Studying this question in youth is particularly
      important given that the onset of most anxiety disorders is during childhood, and early
      interventions may reduce long-term affliction. The current study is the first randomized
      control trial designed to examine the augmenting effects of ABMT on CBT among clinically
      anxious youth.

      The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape
      anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic
      tool. During training, the target location is systematically manipulated to increase the
      proportion of targets appearing at the location opposite the patient's bias. For example, in
      a training protocol intended to reduce threat bias, targets would appear more frequently at
      locations of neutral than threat stimuli.

      Although CBT is an effective treatment for anxiety disorders, combining it with other
      treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two
      interventions targeting different aspects of anxiety and therefore could potentially
      complement one another. While CBT modifies explicit and voluntary attention through verbal
      intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT,
      the integration of the two treatments can have few significant benefits: First, it will
      combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce
      the number of patients who respond poorly to CBT or do not respond at all. Second,
      computer-based training of attention may be more acceptable than traditional in-person
      therapy formats for some children and adolescents and can raise the cooperation in therapy.
      Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered
      consistently

      The current study was designed to examine the ABMT augmentation effects on CBT for children
      with anxiety disorders. This study is the first randomized control trial in clinically
      anxious youth. Participants were randomly assigned to one of three conditions: 1. Training
      condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT
      alone). We hypothesize that participants in the training condition will show the greatest
      improvement in anxiety symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in frequency of anxiety symptoms (based on ADIS)
time frame: Change from baseline to up to 3 weeks after last treatment session
description: Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.
measure: Change in severity of anxiety symptoms (based on ADIS)
time frame: Change from baseline to up to 3 weeks after last treatment session
description: ADIS interview (see above)
measure: SCARED parent/child
time frame: pre and post treatment
description: The SCARED-R is 41- items parent and child reported questionnaire, measuring DSM-IV defined anxiety disorder symptoms in children. The scale measures symptoms of separation anxiety, generalized anxiety disorder, panic disorder, social phobia and school phobia. SCARED-R total and subscale scores can be obtained by summing across relevant items. The SCARED-R is a valid and reliable child anxiety instrument {Muris, 2001 #2;Muris, 2001 #3;Muris, 1999 #4} that has been extensively used in clinical and research contexts in Israel {Eldar, 2012 #32}.
arm group label: ABMT + CBT
arm group type: Experimental
description: CBT and ABMT
arm group label: CBT Alone
arm group type: Other
description: CBT alone (compare/control group)
arm group label: ABMT placebo + CBT
arm group type: Placebo Comparator
description: ABMT placebo training and CBT
intervention type: Behavioral
intervention name: Cognitive behavioral therapy for anxiety
arm group label: ABMT + CBT
arm group label: ABMT placebo + CBT
arm group label: CBT Alone
intervention type: Behavioral
intervention name: Attention Bias Modification Treatment
arm group label: ABMT + CBT
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Yair Bar-Haim, Ph.D
role: Principal Investigator
affiliation: Tel Aviv University
last name: Tomer Shechner, Ph.D
role: Study Director
affiliation: Tel Aviv University/Schneider children medical center
last name: Alan Apter, M.D.
role: Study Chair
affiliation: Tel Aviv University/Schnider children medical center
citation: Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
PMID: 22423353
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Yair Bar-Haim
investigator title: Prof. Yair Bar-Haim, Ph.D.
mesh term: Anxiety Disorders