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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: Completed NA study, sponsored by Florida State University.
NCT05503017 is a NA study that has completed, run by Florida State University. The registered enrollment target is 248 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
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 |
What the finished NCT05503017 record still lists
NCT05503017 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Psycho-social, computerized intervention targeting error sensitivity is the first listed.
NCT05503017 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05503017's enrollment target sits among peer trials
248 434th of 2000 higher than 1,565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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