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Novel Anxiety Treatment

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ClinicalTrials.gov Identifier: NCT03790696
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Cognitive Training Anxiety Disorders Device: Cognitive Training Program Not Applicable

Detailed Description:

Children will be recruited through local schools, pediatricians' offices, and through Dr. Sylvester's child anxiety clinic by asking staff to present Institutional Review Board (IRB) approved recruitment materials to potentially interested families. The investigators will also recruit with advertisements and placement of approved flyers, paragraphs and materials throughout the greater Washington University community as well as throughout the St. Louis community.

The research assistant will make 'screening materials' available to recruitment sites including schools and pediatricians' offices. Staff at these recruitment sites will identify potential participants and distribute materials accordingly. Staff will only provide recruitment materials and will not answer questions regarding the study -- all questions will be answered by study staff. Screening materials will include a consent script, the contact information sheet, the SCARED, and the MFQ.

A member of the research team will review screening materials and contact potential participants by phone on the basis of meeting inclusion criteria. This member of the research team will provide parent participants with information about the study and required elements of consent over the telephone (see attached "Initial Phone Screen") prior to obtaining the parent's verbal consent to participate in the screening elements of the study (Initial Phone Screen as well as SCARED/MFQ).

If a parent and child meet eligibility criteria for enrollment in the study based on their Initial Phone Screen, and parents indicate they wish to continue with the study, the research team will arrange an in-person assessment. On the day of the in-person assessment, a research assistant will provide ample time for the parents to read/review the consent form and will answer any questions the parent may have prior to signing. Research team members will remind participants that their participation is completely voluntary and they can choose to withdraw at any time.

After the in-person assessment, the participant may be asked to return for another visit to complete functional magnetic resonance imaging. This additional visit will be optional and not a requirement of participation in the overall study. The subject can choose not to participate in this phase of the study and may withdraw at any time. If the subject is interested, the investigators will obtain a separate document of informed consent for the imaging phase. As in the original informed consent document, immediately after the in-person assessment, a research assistant will provide ample time for the parents to read/review the imaging consent form and will answer any questions the parent may have prior to signing.

The research assistant may also ask the participants at the end of the in-person assessment whether the investigators could call them in the future to participate in the imaging phase of the study. If the participant agrees, the team will call the participant within the next 3 months to set up an appointment. In this case, the informed consent for imaging would be obtained at the beginning of the imaging visit with all of the above procedures applying.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This study is a randomized control trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Novel Mechanism-Based Treatment for Pediatric Anxiety Disorders
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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.

Other Names:
  • novel computer-based cognitive training program
  • computer-delivered cognitive training program

Sham Comparator: Sham Cognitive Training
Participants will complete 30-45 minute cognitive training program twice a week for four weeks.
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.

Other Names:
  • novel computer-based cognitive training program
  • computer-delivered cognitive training program




Primary Outcome Measures :
  1. Change in symptoms of anxiety based on Screen for Anxiety and Related Disorders (SCARED) [ Time Frame: Children/Caregivers will complete the SCARED measure at their baseline appointment before beginning treatment, at treatment session 2,4,6,8, as well as at their final appointment after 4 weeks of completing the training. ]
    The primary outcome will be reduction in symptoms of anxiety as measured by the SCARED in study Phase 2. Total SCARED scores at sessions 2, 4, 6, and 8 will be subtracted from the baseline SCARED score, yielding a delta SCARED score for each visit. These data will be analyzed with a mixed random effects repeated-measures model. In this model, time, treatment (active versus sham), and time x treatment interaction are fixed effects; baseline SCARED scores and subject within treatment are random effects; and delta SCARED scores are the dependent variable. Our hypothesis predicts a significant time x treatment interaction, with a greater decrease in anxiety from pre- to post- training in the active relative to the sham group. A total score of ≥ 25 may indicate the presence of an Anxiety Disorder. Scores higher than 30 are more specific. The minimum score is a 0 and maximum score is 82.

  2. Change in symptoms of anxiety based on Pediatric Anxiety Rating Scale (PARS). [ Time Frame: 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. ]

    Secondary outcomes will include symptoms of anxiety on the PARS and diagnostic status. The investigators will test whether active versus sham training significantly reduces symptoms in children with anxiety disorders. The primary outcome will be reduction in symptoms of anxiety as measured by the PARS. The investigators will perform a 2 x 2 ANOVA with treatment arm (active versus sham) and time (pre- versus post-training) as effects of interest.

    The PARS is a clinician-administered measure of pediatric anxiety that incorporates both parent and child report.The total score for the PARS is total of the 7 severity items. The total score ranges from 0 to 35.




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790696


Contacts
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Contact: Jennifer Harper, BS 3142862697 jenniferharper@wustl.edu

Locations
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United States, Missouri
Washinton University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Jennifer Harper, BS    314-286-2697    jenniferharper@wustl.edu   
Principal Investigator: Chad Sylvester, MD, PhD         
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03790696     History of Changes
Other Study ID Numbers: 201702012
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders