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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 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04157296
The ClinicalTrials.gov registry entry for NCT04157296 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive behavioral therapy (CBT) is the first listed.
NCT04157296 reports 0 study locations.
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.
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