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

NCT02460536 | Completed

• 1 other identifier: 2009341
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

attention bias modification treatment; attention training; anxiety disorders; clinical trials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P)

  4 weeks, 8 weeks, and 18 weeks (follow-up)

Study Arms (4)

Attention Bias Modification treatment (ABMT)

EXPERIMENTAL

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

Behavioral: Attention Bias Modification treatment (ABMT)

Exposure only +ABMT

ACTIVE COMPARATOR

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

Behavioral: Exposure only +ABMT

Attention training only +ABMT

ACTIVE COMPARATOR

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

Behavioral: Attention training only +ABMT

Placebo group

PLACEBO COMPARATOR

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

Behavioral: Placebo group

Interventions

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.

Attention Bias Modification treatment (ABMT)

Exposure only +ABMT BEHAVIORAL

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

Exposure only +ABMT

Attention training only +ABMT BEHAVIORAL

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

Attention training only +ABMT

Placebo group BEHAVIORAL

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

Placebo group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Neuroscience, Head School of Psychological Sciences

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

IL (1)