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

NCT ID: NCT02709980

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-07-31

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.

Conditions

TBI; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sleep Education

6 sessions of sleep education.

Group Type: PLACEBO_COMPARATOR

Sleep Education

Intervention Type: BEHAVIORAL

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.

Cognitive Behavior Therapy for Insomnia

6 sessions of cognitive behavioral therapy for insomnia (CBT-I).

Group Type: ACTIVE_COMPARATOR

Cognitive Behavior Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Buenaver, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00062258

Identifier Type: -

Identifier Source: org_study_id