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

NCT02709980 | Completed DMC

• 1 other identifier: IRB00062258
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI; Insomnia

Keywords

Brain Injury; Insomnia; Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depressive Symptoms

  5 months

• Anxiety Symptoms

  5 months

Study Arms (2)

Sleep Education

PLACEBO COMPARATOR

6 sessions of sleep education.

Behavioral: Sleep Education

Cognitive Behavior Therapy for Insomnia

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy for Insomnia

Interventions

Sleep Education 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.

Sleep Education

Cognitive Behavior Therapy for Insomnia 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.

Cognitive Behavior Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Luis Buenaver, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 16, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

US (1)