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NCT03261674 · ClinicalTrials.gov registry record · NA
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT03261674: Completed NA study, sponsored by VA Office of Research and Development.
NCT03261674 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 110 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03261674, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
Primary Outcome
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Interventions
- BEHAVIORAL CBT-I
- BEHAVIORAL ABT-I
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2018-06-28 |
| Est. Completion | 2024-04-25 |
| Phase | NA |
What the finished NCT03261674 record still lists
NCT03261674 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (92% lower).
The record links to 0 conditions, and to 2 interventions - of which CBT-I is the first listed.
NCT03261674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03261674 about?
NCT03261674 is a clinical study titled "Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury". The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
What is the current status of trial NCT03261674?
This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2018-06-28. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT03261674?
The interventions under investigation include: CBT-I (BEHAVIORAL), ABT-I (BEHAVIORAL).
Who is sponsoring clinical trial NCT03261674?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03261674's enrollment target sits among peer trials
110 816th of 2000 higher than 1,176 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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