Clinical trial NCT04885205: Use of CBT-I in Individuals With a Concussion
Official title: Use of Cognitive Behavioral Therapy for Insomnia in Individuals With a Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: change in Insomnia Severity Index
timeFrame: baseline to 21 weeks
measure: change in PSQI
timeFrame: baseline to 21 weeks
measure: change in Post-Concussion Symptom Scale
timeFrame: baseline to 21 weeks
measure: change in Beck Anxiety Inventory
timeFrame: baseline to 21 weeks
measure: change in Beck Depression Inventory
timeFrame: baseline to 21 weeks
Secondary outcomes:
measure: change in Dysfunctional Beliefs About Sleep (DBAS)
timeFrame: baseline to 21 weeks
measure: change in Sleep Self-Efficacy
timeFrame: baseline to 21 weeks
measure: change in RU-SATED questionnaire
timeFrame: baseline to 21 weeks
measure: change in plasma neurofilament light (NfL)
timeFrame: baseline to 21 weeks
measure: change in plasma pTau181
timeFrame: baseline to 21 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Catherine Siengsukon
state: Kansas
Study officials:
References:
citation: Ludwig R, Rippee M, D'Silva LJ, Radel J, Eakman AM, Morris J, Drerup M, Siengsukon C. Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 23;11(9):e38608. doi: 10.2196/38608.