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

National Institutes of Health Clinical Center (CC)

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Active Attention Bias Modification Training; Behavioral: Placebo Attention Bias Modification Training

Study type: Interventional

Funder types: NIH

Identifiers

NCT03283930

0192A

Details and patient eligibility

About

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.

Full 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)

Enrollment: 121 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

Active Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Active Attention Bias Modification Training

Control Intervention

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Placebo Attention Bias Modification Training