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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; TBI
• Intervention / Treatment: Behavioral: Sleep Education; Behavioral: Cognitive Behavior Therapy for Insomnia

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sleep Education; 6 sessions of sleep education.	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.
Active Comparator: Cognitive Behavior Therapy for Insomnia; 6 sessions of cognitive behavioral therapy for insomnia (CBT-I).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	Insomnia severity will be operationalized as Sleep efficiency (an estimate of the amount of time spent sleeping relative to time in bed) = (Total time asleep) / (Time in Bed) x 100; sleep continuity (this will be derived from aggregating total time awake from the initial onset of sleep through the final awakening at the end of the sleep period); & total sleep time.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Depression = Patients will complete psychometrically validated depressive symptoms questionnaires (e.g., Beck Depression Inventory, Patient Health Questionnaire - 9 item).	5 months
Anxiety Symptoms	Anxiety = Patients will complete psychometrically validated anxiety symptoms questionnaires (e.g., Beck Anxiety Inventory, Generalized Anxiety Disorder-7 item).	5 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Academy of Sleep Medicine
• Investigators: Principal Investigator: Luis Buenaver, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic
• Other Study ID Numbers: IRB00062258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED