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Concussion, MildNCT04885205

Use of CBT-I in Individuals With a Concussion

A study testing cognitive behavioral therapy for insomnia (CBT-I) in people with Concussion, Mild, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Concussion, Mild
What is being tested?
cognitive behavioral therapy for insomnia (CBT-I)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
30 Apr 2021to 2 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Catherine Siengsukon

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: 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.

Being tested
cognitive behavioral therapy for insomnia (CBT-I)
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behavioral therapy for insomnia (CBT-I)Behavioural

    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:

Study groups in NCT04885205
Study groupRoleWhat they receive
CBT-I Initial GroupExperimentalThe 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.
Receives: Behavioral: cognitive behavioral therapy for insomnia (CBT-I)
Wait List GroupActive comparatorThe 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.
Receives: Behavioral: cognitive behavioral therapy for insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Insomnia Severity Index

    7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28

    Measured: baseline to 21 weeks

  2. change in PSQI

    Scores range from 0-21 with a higher score indicating a lower quality of sleep

    Measured: baseline to 21 weeks

  3. 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.

    Measured: baseline to 21 weeks

  4. 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).

    Measured: baseline to 21 weeks

  5. change in Beck Depression Inventory

    21 item questionnaire used to assess the severity of depression. Scores range from 1 to greater than 40.

    Measured: baseline to 21 weeks

Secondary outcomes (5)

  1. 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

    Measured: baseline to 21 weeks

  2. 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

    Measured: baseline to 21 weeks

  3. 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.

    Measured: baseline to 21 weeks

  4. change in plasma neurofilament light (NfL)

    blood marker of axonal damage

    Measured: baseline to 21 weeks

  5. change in plasma pTau181

    blood marker of tauopathy

    Measured: baseline to 21 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start30 Apr 2021
  3. Primary completion2 Dec 2022
  4. Study completion2 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885205
Sponsor's protocol ID
STUDY00146439
Status last verified
Mar 2023
First submitted
9 Mar 2021
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ludwig R, Rippee M, D'Silva L, Radel J, Eakman AM, Morris J, Beltramo A, Drerup M, Siengsukon C. The Impact of Cognitive Behavioral Therapy for Insomnia on Neurofilament Light and Phosphorylated Tau in Individuals with a Concussion. Arch Clin Neuropsychol. 2025 Apr 27;40(3):437-444. doi: 10.1093/arclin/acae096.

    PubMed 39504933

  • 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.

    PubMed 36149737

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavioral therapy for insomnia (CBT-I) in people with Concussion, Mild, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Insomnia Severity Index (time frame: baseline to 21 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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