Use of CBT-I in Individuals With a Concussion

Study Overview
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Brief Summary
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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.

Official Title
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Use of Cognitive Behavioral Therapy for Insomnia in Individuals With a Concussion

Conditions
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Concussion, Mild

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy for insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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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 3to item 9) History of diagnosed nervous system disorder other than concussion (such as multiple sclerosis, Parkinson's Disease, Stroke) Currently works nightshift

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I Initial Group<br>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)<br>* 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:<br>|
| Active Comparator: Wait List Group<br>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)<br>* 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:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Insomnia Severity Index | 7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28 | baseline to 21 weeks | 
| change in PSQI | Scores range from 0-21 with a higher score indicating a lower quality of sleep | baseline to 21 weeks | 
| change in Post-Concussion Symptom Scale | Severity of 22 concussion-related symptoms are assessed by a Likert scale 0-6. Participants will rate their symptoms from a 0 or no symptom to 6 extreme symptom. A score of 132 is the maximum someone can have indicating all symptoms are severe. 2. The number of post-concussion symptoms will be assessed by counting the number of symptoms that the participant identified as having a severity of 1 or higher on the PCSS. A score of a 1 indicates that the symptom is mild, but still noticeable. | baseline to 21 weeks | 
| change in Beck Anxiety Inventory | The tool consists of 21 items that are scored on a Likert scale of 1-3. Scores range from minimal anxiety (0-7), mild anxiety (8-15) moderate anxiety (16-25) and severe anxiety (<30). | baseline to 21 weeks | 
| change in Beck Depression Inventory | 21 item questionnaire used to assess the severity of depression. Scores range from 1 to greater than 40. | baseline to 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Dysfunctional Beliefs About Sleep (DBAS) | 30 item Likert-scale self-report questionnaire with 0 = strongly disagree to 10 = strongly agree; scores range from 0-300 and a higher score indicates more dysfunctional beliefs about sleep | baseline to 21 weeks | 
| change in Sleep Self-Efficacy | 9 item self-report Likert-scale questionnaire; Scores range from 0-45 and a higher score indicates higher sleep self-efficacy | baseline to 21 weeks | 
| change in RU-SATED questionnaire | to 6 questions asking sleep regularity, subjective satisfaction, appropriate timing, adequate duration, high sleep efficiency, and sustained alertness during the day; Participants answer each question with Rarely/ Never (0),  Sometimes (1), and Usually/ Always (2). There are ten points possible. | baseline to 21 weeks | 
| change in plasma neurofilament light (NfL) | blood marker of axonal damage | baseline to 21 weeks | 
| change in plasma pTau181 | blood marker of tauopathy | baseline to 21 weeks |