<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/NCT03764644</url>
  </required_header>
  <id_info>
    <org_study_id>S13-11</org_study_id>
    <nct_id>NCT03764644</nct_id>
  </id_info>
  <brief_title>Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders</brief_title>
  <acronym>ATTENTIO</acronym>
  <official_title>Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders: a Randomized, Double-blind, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates&#xD;
      as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive&#xD;
      Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other&#xD;
      psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts.&#xD;
      These negative consequences endorse the urgent need to develop more effective and accessible&#xD;
      treatments that enhance effectiveness of current treatment options. A promising new treatment&#xD;
      for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is&#xD;
      based on evidence that anxiety-disordered individuals selectively allocate their attention&#xD;
      toward threatening information (i.e. attention bias). This bias in early and automatic&#xD;
      attention processes starts a cascade of subsequent biases in information processing and&#xD;
      memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of&#xD;
      anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening&#xD;
      information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later&#xD;
      stages of information processing that are under volitional control. Meta-analyses of studies&#xD;
      in adults have shown that ABMT indeed results in increased recovery rates and clinically&#xD;
      significant changes in anxiety, compared to so-called &quot;sham&quot; attention training (control&#xD;
      condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity&#xD;
      to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in&#xD;
      anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by&#xD;
      combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The&#xD;
      primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for&#xD;
      anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham&#xD;
      attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize&#xD;
      that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT&#xD;
      alone, and (2) ABMT will result in a significantly better treatment success than sham&#xD;
      attention training. The design will be a randomized, double-blind, sham-controlled clinical&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety disorders are the most prevalent psychiatric disorders, occurring in among 15% to 20%&#xD;
      of children. Cognitive behavioral therapy (CBT) is currently the first-choice treatment for&#xD;
      anxiety-disordered children. Despite proven efficacy, almost half of them do not respond,&#xD;
      causing prolonged suffering. Children with persistent anxiety have an increased risk for&#xD;
      other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide&#xD;
      attempts. Another concern is that only a small proportion of anxiety-disordered children&#xD;
      actually receive treatment. These negative consequences in combination with the limited&#xD;
      accessibility of treatment endorse the urgent need to develop more effective and accessible&#xD;
      treatments that can enhance effectiveness of current treatment options.&#xD;
&#xD;
      A newly emerging and promising childhood anxiety treatment is Attention Bias Modification&#xD;
      Treatment (ABMT). ABMT is build upon evidence that anxious children tend to selectively focus&#xD;
      their attention on threatening information in the context of other non-threatening&#xD;
      information, and that attention bias is related to development and maintenance of anxiety&#xD;
      disorders. Children with an attention bias scan their environment for potential threat or&#xD;
      danger thereby starting a cascade of subsequent processing biases in interpretation and&#xD;
      memory, resulting in heightened anxiety.&#xD;
&#xD;
      Hence, as attention bias is an underlying mechanism of anxiety, treatment that diminishes&#xD;
      attention bias toward threat in anxiety-disordered individuals should alleviate anxiety.&#xD;
      Subsequently, several researchers began to examine the effect of ABMT, which implicitly&#xD;
      trains anxiety-disordered individuals to attend away from threat toward neutral information.&#xD;
      This is a different approach than CBT, which does not target early and automatic information&#xD;
      processes, but addresses later stages of information processing that are under volitional&#xD;
      control. Several studies highlighted the potential of ABMT in reducing anxiety levels in&#xD;
      adults. A meta-analysis revealed that ABMT in adults produces significantly greater&#xD;
      reductions in anxiety than sham control training, with a large effect size in clinical&#xD;
      populations. A previous study found that 72% of the adults were free from their primary&#xD;
      anxiety disorder after ABMT as compared to 11% after sham attention training, which is far&#xD;
      more than CBT. These training effects were maintained at 4-month follow-up. Importantly, ABMT&#xD;
      also modifies neural systems that are involved in the control of attention to emotional&#xD;
      stimuli, in particular the lateral prefrontal cortex.&#xD;
&#xD;
      Despite the promising results in adults, ABMT has been scarcely examined in children. A few&#xD;
      studies demonstrated a significant anxiolytic effect of ABMT, but not of the sham control&#xD;
      condition. A major limitation of previous studies is that sample sizes were quite low and&#xD;
      that a limited number of training sessions were provided. It has been shown that more&#xD;
      training sessions enhance the magnitude of treatment effect. This is the first study that&#xD;
      examines the effectiveness of a 9-session web-based ABMT in a large sample of&#xD;
      anxiety-disordered children as well as examines the additive effect of web-based ABMT on CBT.&#xD;
&#xD;
      As reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and&#xD;
      there is an urgent need for improvement of current treatment strategies. An innovative, but&#xD;
      scarcely examined, treatment option for childhood anxiety disorders is ABMT. A randomized,&#xD;
      sham-controlled, double-blind trial of web-based Attention Bias Modification Treatment for&#xD;
      childhood anxiety disorders will be conducted. One hundred twenty-eight children will be&#xD;
      randomly allocated to a 9 session internet-delivered ABMT or sham attention training. The&#xD;
      primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for&#xD;
      anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham&#xD;
      attention training on anxiety disorder recovery rates and changes in anxiety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim results showed high futility to continue&#xD;
  </why_stopped>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>
    <intervention_model_description>Double blind, sham-controlled, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety disorder status</measure>
    <time_frame>After 3 weeks of ABMT or sham-ABMT</time_frame>
    <description>Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety disorder status</measure>
    <time_frame>After 10 weeks of CBT</time_frame>
    <description>Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety disorder status</measure>
    <time_frame>6 months follow-up (from last CBT session)</time_frame>
    <description>Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of anxiety disorders</measure>
    <time_frame>After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up</time_frame>
    <description>Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up</time_frame>
    <description>Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up</time_frame>
    <description>Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of anxiety disorders</measure>
    <time_frame>After 10 weeks of CBT</time_frame>
    <description>Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>After 10 weeks of CBT</time_frame>
    <description>Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>After 10 weeks of CBT</time_frame>
    <description>Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of anxiety disorders</measure>
    <time_frame>6 months follow-up (from last CBT session)</time_frame>
    <description>Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>6 months follow-up (from last CBT session)</time_frame>
    <description>Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>6 months follow-up (from last CBT session)</time_frame>
    <description>Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Anxiety Disorder</condition>
  <condition>Anxiety Disorder of Childhood</condition>
  <condition>Separation Anxiety Disorder of Childhood, Early Onset</condition>
  <condition>Specific Phobia</condition>
  <condition>Social Anxiety Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Combined ABMT and CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Sham ABMT and CBT</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combined ABMT and CBT</intervention_name>
    <description>ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual</description>
    <arm_group_label>Combined ABMT and CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combined Sham ABMT and CBT</intervention_name>
    <description>ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual</description>
    <arm_group_label>Combined Sham ABMT and CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for participation are children (aged 8 to 16 years)&#xD;
&#xD;
          -  Primary diagnosis of separation anxiety disorder,&#xD;
&#xD;
          -  Primary diagnosis of generalized anxiety disorder&#xD;
&#xD;
          -  Primary diagnosis of specific phobia&#xD;
&#xD;
          -  Primary diagnosis of social phobia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ below 85&#xD;
&#xD;
          -  poor command of the Dutch language&#xD;
&#xD;
          -  serious physical disease&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  substance abuse&#xD;
&#xD;
          -  pervasive developmental disorder&#xD;
&#xD;
          -  obsessive-compulsive disorder&#xD;
&#xD;
          -  posttraumatic stress disorder&#xD;
&#xD;
          -  acute stress disorder&#xD;
&#xD;
          -  panic disorder&#xD;
&#xD;
          -  major depression&#xD;
&#xD;
          -  anxiety medication during treatment&#xD;
&#xD;
          -  any concurrent psychotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeroen Legerstee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasmus MC - Sophia Children's Hospital</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3000 CB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Jeroen Legerstee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Anxiety, Separation</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/NCT03764644
org study id: S13-11
nct id: NCT03764644
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates
      as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive
      Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other
      psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts.
      These negative consequences endorse the urgent need to develop more effective and accessible
      treatments that enhance effectiveness of current treatment options. A promising new treatment
      for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is
      based on evidence that anxiety-disordered individuals selectively allocate their attention
      toward threatening information (i.e. attention bias). This bias in early and automatic
      attention processes starts a cascade of subsequent biases in information processing and
      memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of
      anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening
      information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later
      stages of information processing that are under volitional control. Meta-analyses of studies
      in adults have shown that ABMT indeed results in increased recovery rates and clinically
      significant changes in anxiety, compared to so-called "sham" attention training (control
      condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity
      to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in
      anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by
      combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The
      primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for
      anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham
      attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize
      that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT
      alone, and (2) ABMT will result in a significantly better treatment success than sham
      attention training. The design will be a randomized, double-blind, sham-controlled clinical
      trial.
Anxiety disorders are the most prevalent psychiatric disorders, occurring in among 15% to 20%
      of children. Cognitive behavioral therapy (CBT) is currently the first-choice treatment for
      anxiety-disordered children. Despite proven efficacy, almost half of them do not respond,
      causing prolonged suffering. Children with persistent anxiety have an increased risk for
      other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide
      attempts. Another concern is that only a small proportion of anxiety-disordered children
      actually receive treatment. These negative consequences in combination with the limited
      accessibility of treatment endorse the urgent need to develop more effective and accessible
      treatments that can enhance effectiveness of current treatment options.

      A newly emerging and promising childhood anxiety treatment is Attention Bias Modification
      Treatment (ABMT). ABMT is build upon evidence that anxious children tend to selectively focus
      their attention on threatening information in the context of other non-threatening
      information, and that attention bias is related to development and maintenance of anxiety
      disorders. Children with an attention bias scan their environment for potential threat or
      danger thereby starting a cascade of subsequent processing biases in interpretation and
      memory, resulting in heightened anxiety.

      Hence, as attention bias is an underlying mechanism of anxiety, treatment that diminishes
      attention bias toward threat in anxiety-disordered individuals should alleviate anxiety.
      Subsequently, several researchers began to examine the effect of ABMT, which implicitly
      trains anxiety-disordered individuals to attend away from threat toward neutral information.
      This is a different approach than CBT, which does not target early and automatic information
      processes, but addresses later stages of information processing that are under volitional
      control. Several studies highlighted the potential of ABMT in reducing anxiety levels in
      adults. A meta-analysis revealed that ABMT in adults produces significantly greater
      reductions in anxiety than sham control training, with a large effect size in clinical
      populations. A previous study found that 72% of the adults were free from their primary
      anxiety disorder after ABMT as compared to 11% after sham attention training, which is far
      more than CBT. These training effects were maintained at 4-month follow-up. Importantly, ABMT
      also modifies neural systems that are involved in the control of attention to emotional
      stimuli, in particular the lateral prefrontal cortex.

      Despite the promising results in adults, ABMT has been scarcely examined in children. A few
      studies demonstrated a significant anxiolytic effect of ABMT, but not of the sham control
      condition. A major limitation of previous studies is that sample sizes were quite low and
      that a limited number of training sessions were provided. It has been shown that more
      training sessions enhance the magnitude of treatment effect. This is the first study that
      examines the effectiveness of a 9-session web-based ABMT in a large sample of
      anxiety-disordered children as well as examines the additive effect of web-based ABMT on CBT.

      As reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and
      there is an urgent need for improvement of current treatment strategies. An innovative, but
      scarcely examined, treatment option for childhood anxiety disorders is ABMT. A randomized,
      sham-controlled, double-blind trial of web-based Attention Bias Modification Treatment for
      childhood anxiety disorders will be conducted. One hundred twenty-eight children will be
      randomly allocated to a 9 session internet-delivered ABMT or sham attention training. The
      primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for
      anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham
      attention training on anxiety disorder recovery rates and changes in anxiety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind, sham-controlled, randomized trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Anxiety disorder status
time frame: After 3 weeks of ABMT or sham-ABMT
description: Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Anxiety disorder status
time frame: After 10 weeks of CBT
description: Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Anxiety disorder status
time frame: 6 months follow-up (from last CBT session)
description: Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Number of anxiety disorders
time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
description: Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Anxiety symptoms
time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
description: Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
measure: Depression symptoms
time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
description: Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
measure: Number of anxiety disorders
time frame: After 10 weeks of CBT
description: Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Anxiety symptoms
time frame: After 10 weeks of CBT
description: Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
measure: Depression symptoms
time frame: After 10 weeks of CBT
description: Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
measure: Number of anxiety disorders
time frame: 6 months follow-up (from last CBT session)
description: Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
measure: Anxiety symptoms
time frame: 6 months follow-up (from last CBT session)
description: Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
measure: Depression symptoms
time frame: 6 months follow-up (from last CBT session)
description: Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
arm group label: Combined ABMT and CBT
arm group type: Experimental
description: 9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
arm group label: Combined Sham ABMT and CBT
arm group type: Sham Comparator
description: 9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
intervention type: Behavioral
intervention name: Combined ABMT and CBT
description: ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
arm group label: Combined ABMT and CBT
intervention type: Behavioral
intervention name: Combined Sham ABMT and CBT
description: ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
arm group label: Combined Sham ABMT and CBT
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Jeroen Legerstee, PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Jeroen Legerstee
investigator title: Principal Investigator
mesh term: Anxiety Disorders
mesh term: Phobia, Social
mesh term: Anxiety, Separation