Study of Behavioral Treatments for Insomnia in Active-Duty Navy Sailors With Traumatic Brain Injury

What this Trial Is About

Researchers are evaluating Cognitive Behavioral Therapy for Insomnia CBT-I in active-duty sailors who have experienced traumatic brain injury TBI. The study aims to compare the effects of traditional in-person CBT-I and CBT-I delivered through a digital health platform called Clinician Operated Assistive Sleep Technology COAST against usual treatment on symptoms of insomnia, post-concussive effects, psychological health, and brain function. Participants will be assessed before treatment, after treatment, and three months later to understand the therapies impacts. The study involves three groups one receiving in-person CBT-I at a TBI clinic or via telehealth, another receiving CBT-I remotely through the COAST digital platform, and a third group receiving treatment as usual without insomnia-specific care. Both CBT-I interventions last six weeks and are delivered by doctoral-level clinicians. Participants in all groups will use the COAST app to complete daily sleep logs and assessments throughout the study. Participants will attend baseline and follow-up appointments where various questionnaires and inventories will be completed to measure insomnia severity, post-concussion symptoms, psychological conditions like PTSD, depression, anxiety, fatigue, and disability. Sleep diaries will be kept daily during the intervention and for one week before the follow-up visit. Medication use and sleep apnea therapy stability will be monitored, and assessments will occur at multiple time points including baseline, mid-treatment, post-treatment, and three months after treatment ends. The total participation duration spans from initial evaluation through the 3-month follow-up.

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