Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.
• Active duty Sailors, activated Reservist Sailors: The study focuses on the treatment in Sailors. Therefore, eligible participants must be active duty Navy, or activated Reservist Navy. Military personnel from other branches, Veterans, other DoD beneficiaries, and civilians are not eligible for the study.
• Diagnosis of chronic insomnia; PSQI score \> 9: The study focuses on the treatment of insomnia. Therefore, eligible participants must have received a diagnosis of chronic insomnia by the study evaluators.
• 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 study evaluators.
• Stable for at least 8 weeks on psychotropic and hypnotic medications: ADSMs currently using prescribed psychotropic and hypnotic medications will be eligible to participate in the trial if they have been on the same medication(s) and at the same dose(s) for at least 8 weeks and there are no expected changes over the course of the acute intervention phase (i.e., up to 6 weeks). Medication usage and changes will nevertheless be tracked prospectively and be considered in the analytical plan should 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 and hypnotic medication.
• 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: ADSM with comorbid with sleep disordered breathing (SDB) will be eligible to participate in the trial if they are currently stable on continuous positive airway pressure therapy for at least 4 weeks. It is increasingly recognized that insomnia and SDB are often comorbid in military samples56-60. Therefore, exclusion of participants with comorbid SDB would significantly compromise the external validity of the proposed clinical trial. However, SDB requires independent treatment and, if untreated or under-treated comorbid sleep disorder, may be exacerbated by sleep restriction or stimuli control.
• Own a smart device: Participants in all three treatment delivery conditions will use the COAST app to complete the electronic daily sleep logs and study assessments. Thus, ownership of a smartphone will be required.