Cognitive Behavior Therapy for Insomnia (CBT-I) in Persons With Traumatic Brain Injury (TBI)



Status:Recruiting
Conditions:Insomnia Sleep Studies, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:12/6/2018
Start Date:January 1, 2017
End Date:April 2019
Contact:Brook Fulton, BA
Email:bfulton1@jhmi.edu
Phone:410-550-5704

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The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a
non-medication treatment, in recent TBI patients compared to a sleep education control
intervention. Patients will participate in CBT-I treatment (or sleep education treatment)
weekly for six weeks, and will have a 3-months follow-up visit in order to examine the
efficacy and time course of treatment. In addition, participants will complete several
self-report questionnaires in order to examine sleep and neuropsychiatric symptoms throughout
treatment.

Approximately 1.7 million people in the United States sustain a traumatic brain injury (TBI)
every year due to various causes (falls, motor vehicle accidents, sports, work, etc.) [9] at
an estimated combined cost of $110 billion made up of direct (e.g., medical) and indirect
(e.g., lost productivity) costs [6]. Insomnia is one of the most common symptoms of traumatic
brain injury (TBI). Sleep disturbance disrupts TBI recovery and increases the likelihood of
developing neuropsychiatric symptoms, specifically putting TBI patients at enhanced risk for
depressive and anxiety symptomatology. Standard pharmacological treatments used for managing
insomnia are poor targets in this population, as they are vulnerable to medication
side-effects. Very few non-pharmacological studies have been conducted to intervene on
insomnia in this population. One such study hints at the effectiveness of cognitive
behavioral therapy for insomnia (CBT-I). The current study seeks to evaluate CBT-I in recent
TBI patients compared to a sleep education control intervention. Participants will wear a
Fitbit and an Actiwatch to objectively evaluate sleep measures. Patients will participate in
CBT-I treatment (or sleep education treatment) weekly for six weeks, and will have a 3-months
follow-up visit in order to examine the efficacy and time course of treatment. In addition,
participants will complete several self-report questionnaires in order to examine sleep and
neuropsychiatric symptoms throughout treatment. This type of non-pharmacological multi-target
therapy is much needed for persons with TBI, as they are at high risk of developing chronic
neuropsychiatric sequelae but are vulnerable to medication side-effects.

Inclusion Criteria:

- Time duration since injury >3 and <60 months

- Report sleep problems for >1 month that developed after the TBI

- Insomnia Severity Index (ISI) score > or = 10

- Display sufficient cognitive capacity to provide informed consent (MoCA > 10)

- 18-65 years of age

Exclusion Criteria:

- Current alcohol or substance abuse/dependence

- Presence of other neurological disorders (e.g., multiple sclerosis, Parkinson's
Disease)

- Presence of an untreated or unstable medical or psychiatric comorbid condition (e.g.,
major depressive disorder or psychotic disorder requiring admission). People using
psychotropic medication, hypnotic or sedative medications may be included if they are
on a stable dosage for the last 1 month prior to the study, if the dose remains stable
throughout the study, and if the medication is judged to not interfere with the study
outcomes.

- Currently on medications known to produce insomnia (e.g., stimulants)

- Cognitive communication difficulties or inability to speak English that would preclude
study participation

- Sleep apnea (AHI >15) or previous diagnosis of. Study participants who use a
continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for
participation if they are below the apnea/hypopnea cutoff while using CPAP and agree
to use the device during study participation.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Luis Buenaver, Ph.D
Phone: 410-550-5704
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mi
from
Baltimore, MD
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