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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CBT-I Initial Group 		The CBT-I Initial Group will start the CBT-I intervention immediately following baseline assessments. After re-assessment 1, participants in the CBT-I Initial Group will continue with typical activities while the WL group will receive the CBT-I intervention. After re-assessment 2, both groups continue typical activities. All participants will complete a third re-assessment 21 weeks after starting the study.
  • Behavioral: cognitive behavioral therapy for insomnia (CBT-I)
    The CBT-I program is a 6-week, 1x/week, one-on-one program. The delivery of CBT-I will be done remotely over a secure teleconference service (Zoom) or phone. Participants will maintain a sleep diary during the course of the program to aid in tailoring the intervention. Each session lasts about 45-60min:
Active Comparator
Wait List Group 		The WL will wait 6 weeks before starting the CBT-I intervention. After re-assessment 1, participants in the CBT-I Initial Group will continue with typical activities while the WL group will receive the CBT-I intervention. After re-assessment 2, both groups continue typical activities. All participants will complete a third re-assessment 21 weeks after starting the study.
  • Behavioral: cognitive behavioral therapy for insomnia (CBT-I)
    The CBT-I program is a 6-week, 1x/week, one-on-one program. The delivery of CBT-I will be done remotely over a secure teleconference service (Zoom) or phone. Participants will maintain a sleep diary during the course of the program to aid in tailoring the intervention. Each session lasts about 45-60min:

More Details

Status
Completed
Sponsor
University of Kansas Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.