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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272959
Enrollment
100
Registered
2014-10-23
Start date
2015-01-31
Completion date
2019-07-31
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology

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.

Interventions

Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.

Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.

Sponsors

United States - Israel Binational Science Foundation
CollaboratorOTHER
Schneider Children's Hospital
CollaboratorOTHER
Sheba Medical Center
CollaboratorOTHER_GOV
Yair Bar-Haim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Pediatric Anxiety Rating Scale (PARS)expected average time frame of 6 weeks.The PARS assesses global anxiety severity across different anxiety disorders in youth.

Secondary

MeasureTime frameDescription
Anxiety Related Emotional Disorders - Child/Parent Version (SCARED-C/P)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

Countries

Israel

Contacts

Primary ContactYair Bar-Haim, Prof.
yair1@post.tau.ac.il972-3-6405465
Backup ContactMarian Linetzky, M.A.
marian.linetzky@gmail.com972-54-4947028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026