Use of CBT-I in Individuals With a Concussion

Completed · Not applicable

Conditions studied: Concussion, Mild

In brief

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 including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of life and productivity at work or school. Additionally, recent research indicates that individuals with a concussion who have poor sleep quality have increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may still be axonal damage after weeks or months after the initial concussion injury. Post-concussion symptoms have been associated with higher levels of these biomarkers and there has been a report of higher levels of NfL and tau years following a concussion event. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet it remains unclear if this treatment method is effective in improving sleep outcomes, reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in individuals post- concussion. The central hypothesis for this project is treating sleep disturbances will yield a clinically relevant reduction in concomitant post-concussion symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia symptoms and improve concomitant post-concussion symptoms in individuals after concussion and if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.

Key facts

Study ID

NCT04885205

Run by

University of Kansas Medical Center

People needed

40

Starts

2021-04-30

Expected to finish

2022-12-02

Last updated by the study team

2023-03-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Catherine Siengsukon — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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