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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460536
• Other study ID #: 2009341
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2018
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)