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

NCT ID: NCT02460536

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-05-31

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Attention Bias Modification treatment (ABMT)

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Exposure only +ABMT

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Attention training only +ABMT

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Exposure only +ABMT

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

Intervention Type: BEHAVIORAL

Attention training only +ABMT

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

Intervention Type: BEHAVIORAL

Placebo group

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

Intervention Type: BEHAVIORAL

Eligibility 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

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Yair Bar-Haim

Professor of Psychology and Neuroscience, Head School of Psychological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel-Aviv University

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

2009341

Identifier Type: -

Identifier Source: org_study_id