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Novel Anxiety Treatment

NCT03790696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-04-27

Study results available
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Summary

The first aim of this study, as mentioned in the attached NIH grant, is to test the feasibility and acceptability of a novel computer-based cognitive training program that is designed to rehabilitate the brain's ventral attention network (VAN), a brain system associated with anxiety disorders.

Once feasibility and acceptability is determined the investigators will begin aim 2 where the investigators will test the efficacy of this novel treatment, which could reduce the symptoms of anxiety disorders in children (and adults) by training them to actively ignore stimuli in turn reducing the activity of the VAN. To test this potential treatment the investigators will recruit 60 children with anxiety disorders and 10 healthy children to compare an active version of a computer training program to a sham version of training. The investigators will also measure VAN reactivity before and after treatment using functional magnetic resonance imaging (fMRI). The rationale of this research is that it could lead to a novel, safe, mechanism-based treatment for a major public health problem.

Conditions

  • Cognitive Training
  • Anxiety Disorders

Interventions

DEVICE

Cognitive Training Program

The cognitive training program has been designed by Dr. Sylvester. It is a simple computer game looking at some shapes and faces on a computer screen and pressing a button when a target shape appears. This is the first study to use this exact computer training regimen for testing in its ability to reduce symptoms of anxiety in children with anxiety disorders. Each session of the computer game takes approximately 45-60 minutes and subjects complete 8 total sessions over one month. The computer game involves paying attention to parts of the screen while distracting square boxes appear at other locations. A target "X" appears at the location that participants are paying attention to and the subjects press a button when it appears.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2020-03-31
Completion
2020-03-31

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 NCT03790696 on ClinicalTrials.gov