Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT

NCT ID: NCT02272959

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-07-31

Brief Summary

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First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. What are the treatment options for these youth? Unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to CBT. Empirical efforts to address this issue are important because youth who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders. This study will address this gap via double-blind randomized controlled trial of Attention Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard CBT. Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Here, participants will be CBT non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of ABMT or placebo control, and again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of ABMT efficacy.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 stimuli.

Group Type EXPERIMENTAL

Attention bias modification treatment (ABMT)

Intervention Type BEHAVIORAL

Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.

Placebo Group

Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli.

Group Type PLACEBO_COMPARATOR

Attention Control Condition

Intervention Type BEHAVIORAL

Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.

Interventions

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Attention bias modification treatment (ABMT)

Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.

Intervention Type BEHAVIORAL

Attention Control Condition

Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

To be included all youth must:

1. have received a full course of CBT and were deemed treatment non-responders.
2. they must still have a primary diagnosis of GAD, SOP, or SAD.
3. if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
4. if they have tics or impulse control problems, those problems must be treated with medication and stable and cause minimal or no impairment.

Exclusion Criteria

1. meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
2. show high likelihood of hurting themselves or others.
3. have not been living with a primary caregiver who is legally able to give consent for the child's participation.
4. be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
5. be involved currently in another psychosocial treatment.
6. have a serious vision problem that is not corrected with prescription lenses.
7. 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

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United States - Israel Binational Science Foundation

OTHER

Sponsor Role collaborator

Schneider Children's Hospital

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Yair Bar-Haim

OTHER

Sponsor Role lead

Responsible Party

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Yair Bar-Haim

Professor of Psychology and Neuroscience, Head School of Psychological Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tel-Aviv University

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yair Bar-Haim, Prof.

Role: CONTACT

972-3-6405465

Marian Linetzky, M.A.

Role: CONTACT

972-54-4947028

Facility Contacts

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Yair Bar-Haim, PhD

Role: primary

Marian Linetzky

Role: backup

Other Identifiers

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loe140498ctil

Identifier Type: -

Identifier Source: org_study_id

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