Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT
Primary Purpose
Anxiety Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention bias modification treatment (ABMT)
Attention Control Condition
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology
Eligibility Criteria
Inclusion Criteria:
To be included all youth must:
- have received a full course of CBT and were deemed treatment non-responders.
- they must still have a primary diagnosis of GAD, SOP, or SAD.
- if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
- 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:
- meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
- show high likelihood of hurting themselves or others.
- have not been living with a primary caregiver who is legally able to give consent for the child's participation.
- be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
- be involved currently in another psychosocial treatment.
- have a serious vision problem that is not corrected with prescription lenses.
- have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Sites / Locations
- Tel-Aviv UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Attention Bias Modification treatment (ABMT)
Placebo Group
Arm Description
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral stimuli.
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli.
Outcomes
Primary Outcome Measures
The Pediatric Anxiety Rating Scale (PARS)
The PARS assesses global anxiety severity across different anxiety disorders in youth.
Secondary Outcome Measures
Anxiety Related Emotional Disorders - Child/Parent Version (SCARED-C/P)
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents.
Screen for Child
Full Information
NCT ID
NCT02272959
First Posted
October 21, 2014
Last Updated
September 16, 2018
Sponsor
Yair Bar-Haim
Collaborators
United States - Israel Binational Science Foundation, Schneider Children's Hospital, Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02272959
Brief Title
Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT
Official Title
Attention Bias Modification Treatment for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yair Bar-Haim
Collaborators
United States - Israel Binational Science Foundation, Schneider Children's Hospital, Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Attention Bias Modification treatment (ABMT)
Arm Type
Experimental
Arm Description
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral stimuli.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Attention bias modification treatment (ABMT)
Intervention Description
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Condition
Intervention Description
Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.
Primary Outcome Measure Information:
Title
The Pediatric Anxiety Rating Scale (PARS)
Description
The PARS assesses global anxiety severity across different anxiety disorders in youth.
Time Frame
expected average time frame of 6 weeks.
Secondary Outcome Measure Information:
Title
Anxiety Related Emotional Disorders - Child/Parent Version (SCARED-C/P)
Description
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents.
Screen for Child
Time Frame
expected average time frame of 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be included all youth must:
have received a full course of CBT and were deemed treatment non-responders.
they must still have a primary diagnosis of GAD, SOP, or SAD.
if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
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:
meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
show high likelihood of hurting themselves or others.
have not been living with a primary caregiver who is legally able to give consent for the child's participation.
be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
be involved currently in another psychosocial treatment.
have a serious vision problem that is not corrected with prescription lenses.
have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Bar-Haim, Prof.
Phone
972-3-6405465
Email
yair1@post.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Linetzky, M.A.
Phone
972-54-4947028
Email
marian.linetzky@gmail.com
Facility Information:
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Email
yair1@post.tau.ac.il
First Name & Middle Initial & Last Name & Degree
Marian Linetzky
Email
marian.linetzky@gmail.com
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
First Name & Middle Initial & Last Name & Degree
Marian Linetzky
12. IPD Sharing Statement
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Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT
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