A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth

Not Applicable

Completed

Conditions: Anxiety Disorders

Interventions: Behavioral: Placebo Attention Bias Modification Training
Behavioral: Active Attention Bias Modification Training

Registration Number: NCT03283930

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary: Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.

Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.

Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis

Methods: In this sub-study,

* Participants will receive open CBT treatment.

* Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.

* This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.

* These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.

Outcome: Symptom improvement will be compared between the two study arms.

Detailed Description: Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.

Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.

Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis who are originally consented on 01-M-0192 will be recruited and randomized to each arm in the sub-study

Methods: In this sub-study,

* Participants will receive open CBT treatment.

* Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.

* This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.

* These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.

Outcome: Symptom improvement will be compared between the two study arms at different times using

* The Pediatric Anxiety Rating Scale (PARS)

* The Clinical Global Impression of Improvement Scale (CGI-I)

* The Children's Global Assessment Scale (CGAS)

* The Screen for Child Anxiety Related Disorders (SCARED)

* The State-Trait Anxiety Inventory for Children (STAI-C)

* The Self-Efficacy Questionnaire (SEQ-C)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Intervention	Placebo Attention Bias Modification Training	Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the control intervention before a CBT session: Part 1. dot-probe task, where a target is equally randomly presented at the previous location of the neutral or the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are equally randomly presented distal of neutral and threatening distractors.
Active Intervention	Active Attention Bias Modification Training	Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the Active Attention Bias Modification Training (ABMT), computer-based attention bias modification training aimed at re-training attentional biases before a CBT session: Part 1. modified dot-probe task, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are always presented distally of threatening distractors.

Primary Outcome Measures

Name	Time	Method
Pediatric Anxiety Rating Scale	Weeks 3, 8, and 12	The Pediatric Anxiety Rating Scale (PARS) measures anxiety symptoms and related functional impairment in youth as continuous outcome. It comprises a 50- item checklist asking for seven dimensions of global severity/ impairment: Each item is rated on a 0- 5 scale by a clinician based on parent- and child-report. The sum score is calculated based on 5 of the 7 sub-scales and ranges from 0 to 25 with higher scores reflecting greater levels of anxiety. PARS score was measured at different time points during the study.
Clinical Global Impression of Improvement Scale	Week 8	The Clinical Global Impression of Improvement (CGI-I) scale is a measure of global symptom improvement rated by clinicians. Scores range from 1-7, with lower scores reflecting greater levels of improvement. This scale provides an ordinal outcome, as participants with CGI-I ratings less than or equal to 3 at week 8 are considered "responders" and participants with scores \>3 at week 8 are considered "non-responders".

Secondary Outcome Measures

Name	Time	Method
Screen for Child Anxiety Related Disorders	Weeks 3, 8, and 12	The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item, dual-informant measure of pediatric anxiety symptoms; we use the mean of the parent and child ratings. The questionnaire consists of five subscales assessing symptoms of generalized anxiety, social anxiety, separation anxiety, panic, and school refusal. Items are rated on a scale from 0 to 2; the overall score range is 0 to 82. Higher scores reflect greater levels of anxiety.
Children's Global Assessment Scale	Weeks 3, 8, and 12	The Children's Global Assessment Scale (CGAS) is a clinician-rated measure of global functioning, with scores ranging from 1 to 100. Higher score indicates better overall functioning.
State-Trait Anxiety Inventory for Children	Weeks 3, 8, and 12	The level of anxiety was assessed using the State-Trait Anxiety Inventory for Children (STAI-C). STAI-C is a 20-item self-report measure of trait anxiety. Items are rated on a scale from 1 to 3; the overall score range is 20-60. Higher scores reflect greater levels of anxiety. STAI-C score was measured at different time points during the study.
Self-Efficacy Questionnaire	Pre-Treatment Screening, Weeks 3, and 12	The Self-Efficacy Questionnaire (SEQ-C) is a 24-item self-report measure of self-efficacy in youth. The questionnaire is made up of three subscales assessing social self-efficacy, academic self-efficacy, and emotional self-efficacy. Items are rated on a scale from 1 to 5; the overall score range is 24-120. Higher scores reflect higher levels of self-efficacy.