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

Not Applicable

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Attention Control Condition; Behavioral: Attention bias modification treatment (ABMT)

• Registration Number: NCT02272959
• Lead Sponsor: Yair Bar-Haim

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 available

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-23
• Study Start: 2015-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Attention Control Condition	Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli.
Attention Bias Modification treatment (ABMT)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tel-Aviv University; 🇮🇱 Tel-Aviv, Israel