Skip to main content
OpenTrials
Completed

NCT Number: NCT04885205

Use of CBT-I 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catherine Siengsukon

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

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:

Primary outcomes

  1. 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

  2. change in PSQI

    Time frame: baseline to 21 weeks

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

  3. 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.

  4. 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).

  5. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. change in plasma neurofilament light (NfL)

    Time frame: baseline to 21 weeks

    blood marker of axonal damage

  5. change in plasma pTau181

    Time frame: baseline to 21 weeks

    blood marker of tauopathy

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 13, 2021
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.