Back to results

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

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Attention Bias Modification treatment (ABMT)

Exposure only +ABMT

Attention training only +ABMT

Placebo group

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring attention bias modification treatment, attention training, anxiety disorders, clinical trials

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tel-Aviv University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Attention Bias Modification treatment (ABMT)

Exposure only +ABMT

Attention training only +ABMT

Placebo group

Arm 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.

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)

The PARS assesses global anxiety severity across different anxiety disorders in youth.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02460536

First Posted

May 27, 2015

Last Updated

September 16, 2018

Sponsor

Tel Aviv University

1. Study Identification

Unique Protocol Identification Number

NCT02460536

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel Aviv University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Attention Bias Modification treatment (ABMT)

Arm Type

Experimental

Arm 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.

Arm Title

Exposure only +ABMT

Arm Type

Active Comparator

Arm Description

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

Arm Title

Attention training only +ABMT

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Attention Bias Modification treatment (ABMT)

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Exposure only +ABMT

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Attention training only +ABMT

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Placebo group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)

Description

The PARS assesses global anxiety severity across different anxiety disorders in youth.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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.

Facility Information:

Facility Name

Tel-Aviv University

City

Tel-Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs