Clinical trial NCT02709980: Cognitive Behavior Therapy for Insomnia (CBT-I) in Persons With Traumatic Brain Injury (TBI)
Official title: Cognitive Behavior Therapy for Insomnia (CBT-I) in Persons With Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI
Insomnia
Keywords: Brain Injury
Insomnia
Sleep
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2016-03-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity
timeFrame: 5 months
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: 5 months
measure: Anxiety Symptoms
timeFrame: 5 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Luis Buenaver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: