Novel Anxiety Treatment

NCT03790696 | Completed Results

• 1 other identifier: 201702012
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Parent Report at Baseline and Post Assessment

  Another outcome will be change in symptoms of anxiety as measured by the SCARED at the baseline and post training assessments. These scores will be subtracted (post training assessment - baseline assessment) to see the change in anxiety symptoms from the beginning of the study to post treatment. A total score of \>25 may indicate the presence of an Anxiety Disorder. Scores higher than 40 are more specific based on the total score for specific items. Scores for the SCARED can range from 0-82.

  Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment as well as at their final appointment after 4 weeks of completing the training.

Secondary Outcomes (2)

• Change in Symptoms of Anxiety Based on Screen for Anxiety and Related Disorders (SCARED) Child Report at Baseline and Post Assessment

  Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment as well as at their final appointment after 4 weeks of completing the training.

• Change in Symptoms of Anxiety Based on Pediatric Anxiety Rating Scale (PARS) From Baseline to Post Assessment.

  The PARS measure will be collected at the baseline appointment before subjects begin the cognitive training as well as after completing 8 cognitive training sessions in four weeks.

Study Arms (2)

Active Cognitive Training

EXPERIMENTAL

Participants will complete 30-45 minute cognitive training program twice a week for four weeks.

Device: Cognitive Training Program

Sham Cognitive Training

SHAM COMPARATOR

Participants will complete 30-45 minute cognitive training program twice a week for four weeks.

Device: Cognitive Training Program

Interventions

Cognitive Training Program DEVICE

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.

Also known as: novel computer-based cognitive training program, computer-delivered cognitive training program

Active Cognitive Training; Sham Cognitive Training

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages of 8-12
• have a current diagnosis of separation anxiety disorder, generalized anxiety disorder, and/or social phobia.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Washinton University School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

An important limitation of the present study is that there was no control group without any cognitive training and the sample size was small. Therefore, we cannot conclusively state that the task itself reduced anxiety as opposed to non-specific factors.

Results Point of Contact

• Title: Jennifer Harper / Clinical Research Coordinator
• Organization: Washington University School of Medicine

jenniferharper@wustl.edu

314-286-2697

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized to active vs. sham treatment on a 50/50 basis. The participants and the staff performing the pre- and post- treatment psychiatric interviews will remain blinded throughout the study. Study staff administering the treatment will be aware of the active vs. sham status of the participant, in order to deliver and monitor the appropriate cognitive training program.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized control trial.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 2, 2019
• Study Start: February 2, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Locations

US (1)