<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/NCT03283930</url>
  </required_header>
  <id_info>
    <org_study_id>0192A</org_study_id>
    <nct_id>NCT03283930</nct_id>
  </id_info>
  <brief_title>ABMT Augmentation of CBT</brief_title>
  <official_title>Attention Bias Modification Training as Augmentation of Cognitive Behavioral Therapy for Anxiety in Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines a computer-based attention bias modification training as an augmentation&#xD;
      of individual cognitive behavioral therapy for pediatric anxiety.&#xD;
&#xD;
      All participants will receive interviews to assess how they are doing in general, including&#xD;
      general mood, degree of nervousness, and behavior. Each participant and one of his or her&#xD;
      parents will be interviewed separately and together. Participants are asked to complete tasks&#xD;
      involving problem-solving, attention, and emotion that involve looking at pictures,&#xD;
      remembering things, testing reaction times, and making simple choices.&#xD;
&#xD;
      Participants with anxiety will first meet with a psychologist for 12 weeks of individual&#xD;
      cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned&#xD;
      to receive either an active computer-based attention bias modification training task or an&#xD;
      inactive/placebo version of this task, administered as part of their therapy treatment. The&#xD;
      active training is thought to help anxiety whereas the inactive training is thought to have&#xD;
      no effect.&#xD;
&#xD;
      The purpose of this part of the study is to understand the best way to help children and&#xD;
      adolescents who are having problems with anxiety. However, more research is needed to find&#xD;
      the best way to help such children and adolescents. During and after the treatment, each&#xD;
      participant will complete verbal and written symptom ratings.&#xD;
&#xD;
      Those who have not improved by the end of the study will be offered other treatment for 1 to&#xD;
      3 months, and the clinicians will help with finding subsequent aftercare. Those who improve&#xD;
      with treatment will continue therapy at NIH until an outside physician is able to assume&#xD;
      responsibility for monitoring medication.&#xD;
&#xD;
      FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The goal of this protocol is to test the efficacy of a computer-based attention&#xD;
      bias modification training (comparing active vs. placebo) as an augmentation of individual&#xD;
      cognitive behavioral therapy for youth with anxiety disorders.&#xD;
&#xD;
      Study Population: A total of 120 children and adolescents (8-17 years old) will be recruited&#xD;
      to participate in this treatment trial.&#xD;
&#xD;
      Design: Participants' psychiatric symptoms and diagnoses will be assessed by clinical&#xD;
      interview. Participants will engage in 12 weeks of individual cognitive behavioral therapy in&#xD;
      addition to being randomized to receive either an active or placebo version of a&#xD;
      computer-based attention bias modification training.&#xD;
&#xD;
      Outcome Measures: The primary outcome measures to be examined are change in scores on the&#xD;
      Pediatric Anxiety Rating Scale and Clinical Global Impression Scale across treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>The Pediatric Anxiety Rating Scale (PARS)</measure>
    <time_frame>Every 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale (CGI)</measure>
    <time_frame>Weekly</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Children, Only</condition>
  <arm_group>
    <arm_group_label>Active ABMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active attention bias modification will be provided in addition to individual cognitive behavioral therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Attention Bias Modification Training</intervention_name>
    <description>Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases</description>
    <arm_group_label>Active ABMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Attention Bias Modification Training</intervention_name>
    <description>Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of&#xD;
             the study will be eligible to complete all procedures completed by other subjects who&#xD;
             consent as 17- year- olds but do not turn 18).&#xD;
&#xD;
          -  Consent: can give consent/assent (Parents will provide consent; minors will provide&#xD;
             assent)&#xD;
&#xD;
          -  IQ: all subjects will have IQ &gt; 70 (Assessment relies on WASI)&#xD;
&#xD;
          -  Language: all subjects will speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious medical condition or condition that interferes with fMRI scanning. (All&#xD;
             patients will have complete physical examination and history.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current use of any psychoactive substance; current suicidal ideation; current&#xD;
             diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to&#xD;
             require pharmacotherapy&#xD;
&#xD;
          -  Current diagnoses Tourette's Disorder, OCD, post-traumatic distress disorder, conduct&#xD;
             disorder, major depressive disorder&#xD;
&#xD;
          -  Past or current history of mania, psychosis, or severe pervasive developmental&#xD;
             disorder&#xD;
&#xD;
          -  Recent use of an SSRI; all subjects must have been free of any SSRI-use for at least&#xD;
             one month (fluoxetine six months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Daniel S Pine, M.D.</last_name>
    <phone>(301) 594-1318</phone>
    <email>pined@mail.nih.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>NIH Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Pine, M.D.</last_name>
      <phone>301-594-1318</phone>
      <email>pined@mail.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Britton JC, Suway JG, Clementi MA, Fox NA, Pine DS, Bar-Haim Y. Neural changes with attention bias modification for anxiety: a randomized trial. Soc Cogn Affect Neurosci. 2015 Jul;10(7):913-20. doi: 10.1093/scan/nsu141. Epub 2014 Oct 24.</citation>
    <PMID>25344944</PMID>
  </reference>
  <reference>
    <citation>White LK, Sequeira S, Britton JC, Brotman MA, Gold AL, Berman E, Towbin K, Abend R, Fox NA, Bar-Haim Y, Leibenluft E, Pine DS. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders. Am J Psychiatry. 2017 Aug 1;174(8):775-784. doi: 10.1176/appi.ajp.2017.16070847. Epub 2017 Apr 14. Erratum In: Am J Psychiatry. 2018 Jan 1;175(1):83.</citation>
    <PMID>28407726</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anxiety, cbt, abmt</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/NCT03283930
org study id: 0192A
nct id: NCT03283930
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study examines a computer-based attention bias modification training as an augmentation
      of individual cognitive behavioral therapy for pediatric anxiety.

      All participants will receive interviews to assess how they are doing in general, including
      general mood, degree of nervousness, and behavior. Each participant and one of his or her
      parents will be interviewed separately and together. Participants are asked to complete tasks
      involving problem-solving, attention, and emotion that involve looking at pictures,
      remembering things, testing reaction times, and making simple choices.

      Participants with anxiety will first meet with a psychologist for 12 weeks of individual
      cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned
      to receive either an active computer-based attention bias modification training task or an
      inactive/placebo version of this task, administered as part of their therapy treatment. The
      active training is thought to help anxiety whereas the inactive training is thought to have
      no effect.

      The purpose of this part of the study is to understand the best way to help children and
      adolescents who are having problems with anxiety. However, more research is needed to find
      the best way to help such children and adolescents. During and after the treatment, each
      participant will complete verbal and written symptom ratings.

      Those who have not improved by the end of the study will be offered other treatment for 1 to
      3 months, and the clinicians will help with finding subsequent aftercare. Those who improve
      with treatment will continue therapy at NIH until an outside physician is able to assume
      responsibility for monitoring medication.

      FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645
Objective: The goal of this protocol is to test the efficacy of a computer-based attention
      bias modification training (comparing active vs. placebo) as an augmentation of individual
      cognitive behavioral therapy for youth with anxiety disorders.

      Study Population: A total of 120 children and adolescents (8-17 years old) will be recruited
      to participate in this treatment trial.

      Design: Participants' psychiatric symptoms and diagnoses will be assessed by clinical
      interview. Participants will engage in 12 weeks of individual cognitive behavioral therapy in
      addition to being randomized to receive either an active or placebo version of a
      computer-based attention bias modification training.

      Outcome Measures: The primary outcome measures to be examined are change in scores on the
      Pediatric Anxiety Rating Scale and Clinical Global Impression Scale across treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: The Pediatric Anxiety Rating Scale (PARS)
time frame: Every 4 weeks
measure: Clinical Global Impression Scale (CGI)
time frame: Weekly
arm group label: Active ABMT
arm group type: Experimental
description: Active attention bias modification will be provided in addition to individual cognitive behavioral therapy
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy
intervention type: Behavioral
intervention name: Active Attention Bias Modification Training
description: Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
arm group label: Active ABMT
intervention type: Behavioral
intervention name: Placebo Attention Bias Modification Training
description: Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases
arm group label: Placebo
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Daniel S Pine, M.D.
phone: (301) 594-1318
email: pined@mail.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
citation: Britton JC, Suway JG, Clementi MA, Fox NA, Pine DS, Bar-Haim Y. Neural changes with attention bias modification for anxiety: a randomized trial. Soc Cogn Affect Neurosci. 2015 Jul;10(7):913-20. doi: 10.1093/scan/nsu141. Epub 2014 Oct 24.
PMID: 25344944
citation: White LK, Sequeira S, Britton JC, Brotman MA, Gold AL, Berman E, Towbin K, Abend R, Fox NA, Bar-Haim Y, Leibenluft E, Pine DS. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders. Am J Psychiatry. 2017 Aug 1;174(8):775-784. doi: 10.1176/appi.ajp.2017.16070847. Epub 2017 Apr 14. Erratum In: Am J Psychiatry. 2018 Jan 1;175(1):83.
PMID: 28407726
responsible party type: Sponsor
mesh term: Anxiety Disorders