NCT02709980

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TBI
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Education	The sleep education intervention will parallel the CBT-I intervention in number, format (in-person) and length of sessions. It is intended to disseminate information about sleep including sleep hygiene information that is widely available. Subjects will be instructed to read and review 6 publications from the American Academy of Sleep Medicine; sessions will review the material to ensure complete access to the information.
BEHAVIORAL	Cognitive Behavior Therapy for Insomnia	Treatment will involve a standardized 6-session intervention, with demonstrated efficacy, that combines education and behavioral techniques to reduce insomnia. The core components include (1) education about sleep and insomnia, stimulus control, and sleep restriction (session 1); (2) sleep hygiene education (session 2); and 3) relaxation training, cognitive therapy, adherence monitoring, adjusting the recommended sleep-wake schedule, and addressing any problems in implementation (session 3-5). The final session will include a review of treatment content and relapse prevention.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-03-16
• Last updated: 2020-07-15

Locations

1 site across 1 country: United States