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NCT04157296 · ClinicalTrials.gov registry record · NA
Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04157296: Completed NA study, sponsored by University of Michigan.
NCT04157296 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157296, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to CBT. The hypothesis of this trial is that CCT with CBT will further increase task control network (TCN) activation and connectivity. Both groups will have one CBT therapy session each week for 12 weeks. However, for participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to complete during the two weeks prior to the first CBT session and during the two weeks after the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes just prior to CBT sessions 4-12. Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment. Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval. Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.
Primary Outcome
Pre- to post-CBT changes in brain activation and function connectivity in the task-control network including fronto-parietal and cingulo-opercular regions mediating cognitive control. Functional activation and connectivity of these brain regions are assessed using a conflict interference computer task performed during MRI scanning.
Interventions
- BEHAVIORAL Cognitive behavioral therapy (CBT)
- BEHAVIORAL computerized cognitive training (CCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2021-11-12 |
| Phase | NA |
What the finished NCT04157296 record still lists
NCT04157296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive behavioral therapy (CBT) is the first listed.
NCT04157296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04157296 about?
NCT04157296 is a clinical study titled "Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety". This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to CBT. The hypothesis of this trial is that CCT with CBT ...
What is the current status of trial NCT04157296?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-02-04. Estimated completion is 2021-11-12.
What interventions are being tested in trial NCT04157296?
The interventions under investigation include: Cognitive behavioral therapy (CBT) (BEHAVIORAL), computerized cognitive training (CCT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04157296?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04157296's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 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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