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

NCT03283930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-04-09

Study results available
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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.

Conditions

  • Anxiety Disorders

Interventions

BEHAVIORAL

Active Attention Bias Modification Training

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

BEHAVIORAL

Placebo Attention Bias Modification Training

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Daniel Pine, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283930 on ClinicalTrials.gov