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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272959
Recruitment Status : Unknown
Verified September 2018 by Yair Bar-Haim, Tel Aviv University.
Recruitment status was:  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

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Attention bias modification treatment (ABMT) Behavioral: Attention Control Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Treatment for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272959


Contacts
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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

Locations
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Israel
Tel-Aviv University Recruiting
Tel-Aviv, Israel
Contact: Yair Bar-Haim, PhD       yair1@post.tau.ac.il   
Contact: Marian Linetzky       marian.linetzky@gmail.com   
Principal Investigator: Yair Bar-Haim, PhD         
Sub-Investigator: Marian Linetzky         
Sponsors and Collaborators
Yair Bar-Haim
United States - Israel Binational Science Foundation
Schneider Children's Hospital
Sheba Medical Center
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Responsible Party: Yair Bar-Haim, Professor of Psychology and Neuroscience, Head School of Psychological Sciences, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02272959    
Other Study ID Numbers: loe140498ctil
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Keywords provided by Yair Bar-Haim, Tel Aviv University:
Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders