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

Tel Aviv University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Placebo group; Behavioral: Attention training only +ABMT; Behavioral: Attention Bias Modification treatment (ABMT); Behavioral: Exposure only +ABMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02460536

2009341

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Attention Bias Modification treatment (ABMT)

Experimental group

Description:

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

Treatment:

Behavioral: Attention Bias Modification treatment (ABMT)

Exposure only +ABMT

Active Comparator group

Description:

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

Treatment:

Behavioral: Exposure only +ABMT

Attention training only +ABMT

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention training only +ABMT

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo group