Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05503017 · ClinicalTrials.gov registry record · NA
Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 248
- Enrollment target
NCT05503017 is a NA study that has completed, run by Florida State University. The registered enrollment target is 248 participants.
The verdict
NCT05503017, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 248 participants
- Enrollment target
Study Summary
Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure. Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment. The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study. The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the interv
Interventions
- BEHAVIORAL Psycho-social, computerized intervention targeting error sensitivity
- BEHAVIORAL Psycho-social, computerized intervention on healthy lifestyle choices
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2025-07-16 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05503017
The ClinicalTrials.gov registry entry for NCT05503017 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psycho-social, computerized intervention targeting error sensitivity is the first listed.
NCT05503017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05503017 about?
NCT05503017 is a clinical study titled "Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children". Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder o...
What is the current status of trial NCT05503017?
This trial is currently completed. It is a NA study. The enrollment target is 248 participants. The study started on 2022-10-12. Estimated completion is 2025-07-16.
What interventions are being tested in trial NCT05503017?
The interventions under investigation include: Psycho-social, computerized intervention targeting error sensitivity (BEHAVIORAL), Psycho-social, computerized intervention on healthy lifestyle choices (BEHAVIORAL).
Who is sponsoring clinical trial NCT05503017?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.