NCT01819311

Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Completed NA Results posted Last updated 18 October 2017

What this trial tests

NA trial testing Attention Bias Modification in Anxiety Disorders in 64 participants. Completed in 23 June 2017.

Timeline

1 April 2013

Primary endpoint
23 June 2017

23 June 2017

Quick facts

Lead sponsor	Florida International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	1 April 2013
Primary completion	23 June 2017
Estimated completion	23 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Attention Bias Modification
• Placebo Attention Task

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

Florida International University

Who can join

Adults 8 to 16, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinician Rating on the Pediatric Anxiety Rating Scale Primary · post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	8.88	± 5.64
Placebo Attention Task	8.12	± 5.03

Clinician Rating on the Pediatric Anxiety Rating Scale Primary · 8-week follow-up

The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	9.50	± 6.05
Placebo Attention Task	5.95	± 4.39

Screen for Child Anxiety Related Emotional Disorders - Parent Version Secondary · post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	22.22	± 14.23
Placebo Attention Task	18.05	± 12.49

Screen for Child Anxiety Related Emotional Disorders - Child Version Secondary · post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	14.15	± 12.78
Placebo Attention Task	12.83	± 13.60

Screen for Child Anxiety Related Emotional Disorders - Parent Version Secondary · 8-week follow-up

The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	21.05	± 14.12
Placebo Attention Task	17.98	± 13.16

Screen for Child Anxiety Related Emotional Disorders - Child Version Secondary · 8-week follow-up

The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.

Group	Value	95% CI
Attention Bias Modification	17.75	± 16.45
Placebo Attention Task	12.09	± 12.18

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of study participation (12 weeks on average). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Attention Bias Modification

Serious: 1/33 (3%)

Deaths: 0/33

Placebo Attention Task

Serious: 0/31 (0%)

Deaths: 0/31

Serious adverse events (1 terms)

Reaction	System	Attention Bias Modification	Placebo Attention Task
Suicidal ideation	Psychiatric disorders	—	—

Most-reported serious reactions: Suicidal ideation.

Data from ClinicalTrials.gov NCT01819311 adverse events section.

Sponsor's own description

This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of Attention Bias Modification Treatment in Youth With Treatment-Resistant Anxiety Disorders.
   Pettit JW, Bechor M, Rey Y, Vasey MW, et al · · 2020 · cited 30× · PMID 30877049 · DOI 10.1016/j.jaac.2019.02.018