- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885205
Use of CBT-I in Individuals With a Concussion
March 14, 2023 updated by: University of Kansas Medical Center
Use of Cognitive Behavioral Therapy for Insomnia in Individuals With a Concussion
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Siengsukon, PT, PhD
- Phone Number: 913-588-6913
- Email: csiengsukon@kumc.edu
Study Contact Backup
- Name: Rebecca Ludwig
- Phone Number: 913-588-0601
- Email: rludwig2@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Catherine Siengsukon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Insomnia Severity Index
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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)
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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
Time Frame: baseline to 21 weeks
|
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)
Time Frame: baseline to 21 weeks
|
blood marker of axonal damage
|
baseline to 21 weeks
|
change in plasma pTau181
Time Frame: baseline to 21 weeks
|
blood marker of tauopathy
|
baseline to 21 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2021
Primary Completion (Actual)
December 2, 2022
Study Completion (Actual)
December 2, 2022
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 13, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00146439
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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