Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

Inclusion Criteria:

1. Active duty Sailors, activated Reservist Sailors: The study focuses on the treatmentin Sailors. Therefore, eligible participants must be active duty Navy, or activatedReservist Navy. Military personnel from other branches, Veterans, other DoDbeneficiaries, and civilians are not eligible for the study.

2. Diagnosis of chronic insomnia; PSQI score > 9: The study focuses on the treatment ofinsomnia. Therefore, eligible participants must have received a diagnosis of chronicinsomnia by the study evaluators.

3. History of TBI: The study focuses on the treatment of insomnia in Sailors with TBI.Therefore, eligible participants must have a confirmed history of TBI by the studyevaluators.

4. Stable for at least 8 weeks on psychotropic and hypnotic medications: ADSMscurrently using prescribed psychotropic and hypnotic medications will be eligible toparticipate in the trial if they have been on the same medication(s) and at the samedose(s) for at least 8 weeks and there are no expected changes over the course ofthe acute intervention phase (i.e., up to 6 weeks). Medication usage and changeswill nevertheless be tracked prospectively and be considered in the analytical planshould changes occur. To ensure that the three groups are equivalent in composition,the randomization process will be stratified by the use/non-use of psychotropic andhypnotic medication.

5. Stable on continuous positive airway pressure therapy for sleep apnea for at least 90 days and usage of 4 hours or more per night, for at least 70% of the nights: ADSMwith comorbid with sleep disordered breathing (SDB) will be eligible to participatein the trial if they are currently stable on continuous positive airway pressuretherapy for at least 4 weeks. It is increasingly recognized that insomnia and SDBare often comorbid in military samples56-60. Therefore, exclusion of participantswith comorbid SDB would significantly compromise the external validity of theproposed clinical trial. However, SDB requires independent treatment and, ifuntreated or under-treated comorbid sleep disorder, may be exacerbated by sleeprestriction or stimuli control.

6. Own a smart device: Participants in all three treatment delivery conditions will usethe COAST app to complete the electronic daily sleep logs and study assessments.Thus, ownership of a smartphone will be required.

Exclusion Criteria:

1. Unable to give informed consent: Individuals who are unable to give informed consentcannot be enrolled in the study. A decisional capacity to consent test, which willbe submitted for approval to the Institutional Review Board (IRB), will be used todetermine whether a potential participant has the capacity to provide consent ontheir own behalf.

2. Severe TBI: Individuals with severe TBI will be excluded from this study due tocomplex medical needs which may require close medical attention and pose safetyconcerns with regards to completing the study procedures.

3. Potential alcohol use disorder: Individuals who meet diagnostic criteria for currentalcohol or substance use disorders will be excluded as these conditions mayperpetuate insomnia and daytime impairments and pose safety concerns with regards tocompleting the study procedures.

4. Inability to comprehend or read English: Participants with demonstrated inability tocomprehend or read English will not be eligible for the study. The intervention ishighly dependent on understanding the treatment rationale and adhering to behavioralsleep modification instructions. The treatment materials for in-person CBT-I and forCBT-I delivered via digital health platform are only available in English at thistime and is the treating clinician's only spoken language. An inability tocomprehend or read English limits engagement in CBT-I, and adversely impacts therisk/benefit ratio of participating in the study. Because the study is limited toADSMs of the United States, it is expected that nearly all potential patients areproficient in reading, writing, speaking, and understanding English, even is Englishis not their primary language.

5. Serious mental health diagnosis such as bipolar disorder or psychosis; or seizuredisorder: Participants who have been previously diagnosed with psychotic or bipolardisorders, or who endorse symptoms of these conditions during the psychiatricassessments, will not be included in the trial because the mild and transient sleepdeprivation induced by sleep restriction and stimulus control may exacerbatesymptoms and increase the risk of participating in the study. Similarly, individualswith untreated or treatment-resistant seizure disorder will be excluded becauseseizures may be precipitated or exacerbated by sleep restriction.

6. Hypersomnia disorder: Potential participants that have been diagnosed withhypersomnia that can be exacerbated by the transient and mild sleep deprivationinduced by sleep restriction and stimulus control will not be included in the trialas the interventions pose greater safety risks for these participants.

7. Working rotating shifts or requiring that the ADSM report to work earlier than 6am:Potential participants working rotating shifts or who are required to work earlierthan 6am will not be included in the trial. Waking up at the same time every day,including on weekends, is a critical aspect of both sleep restriction and stimuluscontrol procedures. Working rotating shifts prohibits participants from adhering tothis critical treatment guideline. Being required to work earlier than 6am similarlypresents a challenge to waking up at the same time every day, especially onnon-workdays when waking earlier than 6am is an unnatural wake time