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NCT04377009 · ClinicalTrials.gov registry record · NA
Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI
A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT04377009: Completed NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT04377009 is a NA study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 125 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04377009, a NA study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
Study Summary
This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members. The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.
Primary Outcome
Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as \>=25% reduction in total symptom score.
Interventions
- DEVICE Sleep Healthy Using the Internet (SHUTi)
- OTHER Education Control Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2023-04-30 |
| Phase | NA |
What the finished NCT04377009 record still lists
NCT04377009 is an interventional study that assigns participants to a tested intervention. The registered 125 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 (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Sleep Healthy Using the Internet (SHUTi) is the first listed.
NCT04377009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04377009 about?
NCT04377009 is a clinical study titled "Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI". This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I...
What is the current status of trial NCT04377009?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2020-07-07. Estimated completion is 2023-04-30.
What interventions are being tested in trial NCT04377009?
The interventions under investigation include: Sleep Healthy Using the Internet (SHUTi) (DEVICE), Education Control Program (OTHER).
Who is sponsoring clinical trial NCT04377009?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04377009's enrollment target sits among peer trials
125 753rd of 2000 higher than 1,243 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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