Status:
COMPLETED
Use of CBT-I in Individuals With a Concussion
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Concussion, Mild
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms inclu...
Eligibility Criteria
Inclusion
- Aged 18 to 64 years old
- At least 4 weeks since concussion injury
- Self-report difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights per week since injury
- Score ≥10 on the Insomnia Severity Index to indicate clinical insomnia.
- Score ≥25 on the Mini-Mental State Examination (MMSE) questionnaire
Exclusion
- Known untreated sleep disorder (such as sleep apnea, restless leg syndrome, circadian rhythm disorder, hypersomnia, parasomnias)
- Increased risk obstructive sleep apnea (STOP BANG Score ≥3)
- Increased risk of restless leg syndrome on RLS-Diagnosis Index
- Increased risk of circadian rhythm sleep-wake disorder (respond "Yes" to all circadian rhythm questions).
- Increased risk of parasomnia (Respond "Yes" to all questions for night mere disorder OR respond "Yes" to all REM sleep arousal disorder: Sleep walking questions, OR responds " Yes" to all REM sleep arousal disorder: Sleep Terrors questions, OR respond "Yes" to all REM sleep behavior disorder questions.)
- Active abuse or history (up to 2 years) of alcohol/ drug dependence as defined by the DSM-V criteria
- Severe mental illness such as schizophrenia or bipolar disorder
- Score of \> 29 on the Beck Depression Inventory or indication of suicidality (response of "2" or "3"to item 9)
- History of diagnosed nervous system disorder other than concussion (such as multiple sclerosis, Parkinson's Disease, Stroke)
- Currently works nightshift
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04885205
Start Date
April 30 2021
End Date
December 2 2022
Last Update
March 17 2023
Active Locations (1)
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1
Catherine Siengsukon
Kansas City, Kansas, United States, 66160