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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02272959
• Other study ID #: loe140498ctil
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: Tel Aviv University
• Contact: Yair Bar-Haim, Prof.
• Phone: 972-3-6405465
• Email: yair1[@]post.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Tel-Aviv University	Tel-Aviv

Sponsors (4)

Lead Sponsor	Collaborator
Yair Bar-Haim	Schneider Children's Hospital, Sheba Medical Center, United States - Israel Binational Science Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.