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NCT02658669 · ClinicalTrials.gov registry record · NA
Cognitive-Behavioral Therapy for Veterans With TBI
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT02658669: Completed NA study, sponsored by VA Office of Research and Development.
NCT02658669 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02658669, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.
Primary Outcome
Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia
- BEHAVIORAL Sleep Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2022-09-30 |
| Phase | NA |
What the finished NCT02658669 record still lists
NCT02658669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive-Behavioral Therapy for Insomnia is the first listed.
NCT02658669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02658669 about?
NCT02658669 is a clinical study titled "Cognitive-Behavioral Therapy for Veterans With TBI". Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exac...
What is the current status of trial NCT02658669?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2016-04-01. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT02658669?
The interventions under investigation include: Cognitive-Behavioral Therapy for Insomnia (BEHAVIORAL), Sleep Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT02658669?
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 NCT02658669's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 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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