Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial

Background: Traumatic brain injury (TBI) in the U.S. military can result in lasting health issues, with insomnia being a common symptom that worsens recovery, cognitive function, and performance, especially when combined with common co-occurring conditions like chronic pain, post-traumatic stress disorder (PTSD), and depression. Insomnia may be an important intervention target for managing post-concussive symptoms and overall functioning in service members who have sustained a TBI. However, the standard of care for the treatment of insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), is not widely available in military health care settings. The aim of this paper is to describe the design and analysis plan of the clinical trial to evaluate and compare two methods for delivering CBTI including in-person CBTI or CBTI delivered remotely via a clinician-supervised digital platform in a sample of active-duty service members presenting for care in a military TBI specialty clinic. Methods: This is a phase II, randomized clinical trial designed to evaluate and compare the effects of CBTI (in-person or via a digital health platform) on sleep, behavioral health, and cognitive functions relative to treatment as usual among a sample of service members with a history of TBI. The effectiveness of in-person CBTI and CBTI delivered via a digital health platform, relative to treatment as usual, will be compared at baseline, after the six-week intervention, and again three months later on symptoms of insomnia, sleep quality, post-concussive symptoms, neurocognitive functioning, and psychological health. Discussion: TBI is common in military personnel, often leading to insomnia that affects health and performance. While CBTI is the first-line recommended treatment for insomnia, CBTI is rarely implemented as the standard of care in military TBI specialty clinics, highlighting the need to assess its role in treating post-concussion symptoms and related issues. Clinical trials evaluating insomnia treatment in U.S. military service members with a history of TBI are essential to inform clinical practice for military TBI patients affected by insomnia and to potentially improve recovery, duty readiness, and cognitive function in this population. Trial registration: ClinicalTrials.gov: NCT06867666 . Registered on 2/26/2025.