Use of CBT-I in Individuals With a Concussion

Concussion, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885205
• Other study ID #: STUDY00146439
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: March 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

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:

Locations

Country	Name	City	State
United States	Catherine Siengsukon	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in PSQI	Scores range from 0-21 with a higher score indicating a lower quality of sleep	baseline to 21 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	change in plasma neurofilament light (NfL)	blood marker of axonal damage	baseline to 21 weeks
Secondary	change in plasma pTau181	blood marker of tauopathy	baseline to 21 weeks