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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with anxiety disorders are assessed on a number of mental health and biological variables. Patients who can agree to attend regular psychotherapy sessions are randomized to receive cognitive behavioral therapy with computer-based augmentation. In one study arm, these patients receive cognitive behavioral therapy with an active form of a computer game. In the other treatment arm, subjects receive cognitive behavioral therapy with a control treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The active and control treatment arms differ in the spatial arrangements of figures on a computer screen. Because these figures are presented for very brief periods of time, subjects cannot easily decipher differences in the arrangements across the active and control treatments. All study team members who work with patients remain blind to the treatment conditions as well.

Study Groups

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Active Intervention

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.

Group Type EXPERIMENTAL

Active Attention Bias Modification Training

Intervention Type BEHAVIORAL

Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases

Control Intervention

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.

Group Type PLACEBO_COMPARATOR

Placebo Attention Bias Modification Training

Intervention Type BEHAVIORAL

Interventions

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Active Attention Bias Modification Training

Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases

Intervention Type BEHAVIORAL

Placebo Attention Bias Modification Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

-ALL JUVENILE SUBJECTS WITH AN ANXIETY DISORDER:

* Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles))
* Symptom Severity: Clinically significant, ongoing anxiety symptoms
* Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety
* Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- old but do not turn 18).
* Consent: can give consent/assent (Parents will provide consent; minors will provide assent)
* IQ: all subjects will have intelligence quotient (IQ) \> 70 (Assessment relies on WASI)
* Language: all subjects will speak English

Exclusion Criteria

* Any serious medical condition or condition that interferes with participation
* Pregnancy
* Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy.
* Current diagnoses Tourette's Disorder, obsessive compulsive disorder (OCD), post-traumatic distress disorder, conduct disorder
* Past or current history of mania, psychosis, or severe pervasive developmental disorder
* Recent use of an selective serotonin reuptake inhibitor (SSRI); all subjects must have been free of any SSRI-use for at least one month (fluoxetine six months) and must not have been treated with an SSRI for their current depressive episode.
* National Institute of Mental Health (NIMH) employees and staff and their immediate family members will be excluded from the study per NIMH policy

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes