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Completed

NCT Number: NCT02460536

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv University

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attention Bias Modification Treatment (ABMT)

Behavioral

Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.

Exposure only +ABMT

Behavioral

Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.

Attention training only +ABMT

Behavioral

Attention training via repeated trials of a dot-probe task using non-emotional stimuli.

Placebo group

Behavioral

Identical discrimination task including a single non-emotional stimulus in each trial.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2015
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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