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

Study Overview
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Brief Summary
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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.

Official Title
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Attention Bias Modification Treatment for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Attention bias modification treatment (ABMT)
* Behavioral: Attention Control Condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Bias Modification treatment (ABMT)<br>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)<br>* Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.<br>|
| Placebo Comparator: Placebo Group<br>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<br>* Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Anxiety Rating Scale (PARS) | The PARS assesses global anxiety severity across different anxiety disorders in youth. | expected average time frame of 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | expected average time frame of 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology