Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious 10-18 year-olds. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. Attentional threat bias, Attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of ABMT efficacy.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Attention Bias Modification treatment (ABMT); Behavioral: Exposure only +ABMT; Behavioral: Attention training only +ABMT; Behavioral: Placebo group

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary diagnosis of GAD, SOP, or SAD.
• Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
• Tics or impulse control problems must be treated with medication, 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 psycho-social 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 face stimuli.	Behavioral: 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 face stimuli.
Active Comparator: Exposure only +ABMT; Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.	Behavioral: Exposure only +ABMT; Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.
Active Comparator: Attention training only +ABMT; Attention training via repeated trials of a dot-probe task using non-emotional stimuli.	Behavioral: Attention training only +ABMT; Attention training via repeated trials of a dot-probe task using non-emotional stimuli.
Placebo Comparator: Placebo group; Identical discrimination task including a single non-emotional stimulus in each trial.	Behavioral: Placebo group; Identical discrimination task including a single non-emotional stimulus in each trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)	The PARS assesses global anxiety severity across different anxiety disorders in youth.	4 weeks, 8 weeks, and 18 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in anxiety related emotional disorders symptoms - 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.	4 weeks, 8 weeks, and 18 weeks (follow-up)

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: clinical trials; anxiety disorders; attention training; attention bias modification treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: 2009341