N/A
N=18
Novel Anxiety Treatment
Cognitive Training · Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03790696 ↗Enrolled (actual)
18
Serious AEs
—
Results posted
Apr 2025
Primary outcome: Primary: Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Parent Report at Baseline and Post Assessment — -20.4; -21.12 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Training Program (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Parent Report at Baseline and Post Assessment |
-20.4; -21.12 | — |
| SECONDARY Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Child Report at Baseline and Post Assessment |
-11.3; -9.75 | — |
| SECONDARY Change in Symptoms of Anxiety Based on Pediatric Anxiety Rating Scale (PARS) From Baseline to Post Assessment. |
-3.86; -1.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ages of 8-12
- have a current diagnosis of separation anxiety disorder, generalized anxiety disorder, and/or social phobia.
Exclusion Criteria
- prior diagnoses of attention deficit hyperactivity disorder (ADHD)
- autism spectrum disorder
- intellectual disability (IQ<70)
- a significant medical problem
- current use of psychotropic medication other than selective serotonin reuptake inhibitor (SSRI) (children who are currently taking an SSRI and are still experiencing symptoms of anxiety will not be excluded).
Data sourced from ClinicalTrials.gov (NCT03790696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.