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

Completed · Not applicable

Conditions studied: TBI, Insomnia

In brief

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.

Key facts

Study ID

NCT02709980

Run by

Johns Hopkins University

People needed

49

Starts

2017-01-01

Expected to finish

2020-07-01

Last updated by the study team

2020-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Bayview — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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