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Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT

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ClinicalTrials.gov Identifier: NCT02272959
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
United States - Israel Binational Science Foundation
Schneider Children's Hospital
Sheba Medical Center
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 23, 2014
Last Update Posted Date September 18, 2018
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
The Pediatric Anxiety Rating Scale (PARS) [ Time Frame: expected average time frame of 6 weeks. ]
The PARS assesses global anxiety severity across different anxiety disorders in youth.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
Anxiety Related Emotional Disorders - Child/Parent Version (SCARED-C/P) [ Time Frame: expected average time frame of 6 weeks. ]
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents. Screen for Child
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT
Official Title  ICMJE Attention Bias Modification Treatment for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial
Brief Summary First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. What are the treatment options for these youth? Unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to CBT. Empirical efforts to address this issue are important because youth who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders. This study will address this gap via double-blind randomized controlled trial of Attention Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard CBT. Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Here, participants will be CBT non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of ABMT or placebo control, and again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of ABMT efficacy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Behavioral: Attention bias modification treatment (ABMT)
    Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.
  • Behavioral: Attention Control Condition
    Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.
Study Arms  ICMJE
  • Experimental: Attention Bias Modification treatment (ABMT)
    Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral stimuli.
    Intervention: Behavioral: Attention bias modification treatment (ABMT)
  • Placebo Comparator: Placebo Group
    Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli.
    Intervention: Behavioral: Attention Control Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2014)
140
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To be included all youth must:

  1. have received a full course of CBT and were deemed treatment non-responders.
  2. they must still have a primary diagnosis of GAD, SOP, or SAD.
  3. if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
  4. if they have tics or impulse control problems, those problems must be treated with medication and stable and cause minimal or no impairment.

Exclusion Criteria: To be excluded youth must:

  1. meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
  2. show high likelihood of hurting themselves or others.
  3. have not been living with a primary caregiver who is legally able to give consent for the child's participation.
  4. be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
  5. be involved currently in another psychosocial treatment.
  6. have a serious vision problem that is not corrected with prescription lenses.
  7. have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yair Bar-Haim, Prof. 972-3-6405465 yair1@post.tau.ac.il
Contact: Marian Linetzky, M.A. 972-54-4947028 marian.linetzky@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272959
Other Study ID Numbers  ICMJE loe140498ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yair Bar-Haim, Tel Aviv University
Study Sponsor  ICMJE Yair Bar-Haim
Collaborators  ICMJE
  • United States - Israel Binational Science Foundation
  • Schneider Children's Hospital
  • Sheba Medical Center
Investigators  ICMJE Not Provided
PRS Account Tel Aviv University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP