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

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Attention Bias Modification treatment (ABMT); Behavioral: Exposure only +ABMT; Behavioral: Placebo group; Behavioral: Attention training only +ABMT

• Registration Number: NCT02460536
• Lead Sponsor: Tel Aviv University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P)	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.

Trial Locations

Locations (1)

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