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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2018

Interventions

  • 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.
  • Behavioral: Exposure only +ABMT
    • Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.
  • Behavioral: Attention training only +ABMT
    • Attention training via repeated trials of a dot-probe task using non-emotional stimuli.
  • Behavioral: Placebo group
    • Identical discrimination task including a single non-emotional stimulus in each trial.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: 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.
  • Placebo Comparator: Placebo group
    • Identical discrimination task including a single non-emotional stimulus in each trial.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from baseline in anxiety related emotional disorders symptoms – Child/Parent Version (SCARED-C/P)
    • Time Frame: 4 weeks, 8 weeks, and 18 weeks (follow-up)
    • The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel Aviv University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yair Bar-Haim, Professor of Psychology and Neuroscience, Head School of Psychological Sciences – Tel Aviv University

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