This paper describes the study protocol for a phase II randomized clinical trial evaluating and comparing in-person CBTI versus clinician-supervised digital platform CBTI versus treatment as usual for insomnia in active-duty service members with traumatic brain injury.
Key Findings
Background
Insomnia is a common symptom following traumatic brain injury in military personnel that worsens recovery, cognitive function, and performance.
TBI in the U.S. military 'can result in lasting health issues, with insomnia being a common symptom'
Insomnia is identified as worsening outcomes 'especially when combined with common co-occurring conditions like chronic pain, post-traumatic stress disorder (PTSD), and depression'
The authors characterize insomnia as 'an important intervention target for managing post-concussive symptoms and overall functioning in service members who have sustained a TBI'
Background
Cognitive Behavioral Therapy for Insomnia (CBTI) is the standard of care for insomnia but is not widely available in military health care settings.
CBTI is described as 'the standard of care for the treatment of insomnia' and 'the first-line recommended treatment for insomnia'
CBTI 'is not widely available in military health care settings'
CBTI 'is rarely implemented as the standard of care in military TBI specialty clinics'
This gap highlights 'the need to assess its role in treating post-concussion symptoms and related issues'
Methods
The trial is designed as a phase II randomized clinical trial with three arms: in-person CBTI, digitally delivered CBTI via a clinician-supervised platform, and treatment as usual.
The study is a 'phase II, randomized clinical trial'
Participants are active-duty service members 'presenting for care in a military TBI specialty clinic'
The two active intervention arms are 'in-person CBTI' and 'CBTI delivered remotely via a clinician-supervised digital platform'
The comparator is 'treatment as usual'
The trial is registered on ClinicalTrials.gov as NCT06867666, registered on 2/26/2025
Methods
The intervention duration is six weeks, with outcomes assessed at baseline, post-intervention, and three-month follow-up.
The intervention is described as a 'six-week intervention'
Assessments occur 'at baseline, after the six-week intervention, and again three months later'
Outcomes measured include 'symptoms of insomnia, sleep quality, post-concussive symptoms, neurocognitive functioning, and psychological health'
Conclusions
The trial aims to inform clinical practice and potentially improve recovery, duty readiness, and cognitive function in military TBI patients affected by insomnia.
The trial is described as 'essential to inform clinical practice for military TBI patients affected by insomnia'
Expected benefits include potential improvement in 'recovery, duty readiness, and cognitive function in this population'
The study targets active-duty service members, emphasizing operational relevance to military readiness
What This Means
This paper describes the design of a clinical trial — not yet completed results — that will test whether a structured talk therapy for sleep problems (called Cognitive Behavioral Therapy for Insomnia, or CBTI) can help active-duty military service members who have had a traumatic brain injury (TBI). Many service members with TBI struggle with insomnia, which makes their recovery harder and affects their thinking and daily performance. Despite CBTI being the recommended first-line treatment for insomnia, it is rarely offered in military TBI clinics, leaving a significant gap in care.
The trial will randomly assign service members with TBI and insomnia to one of three groups: traditional in-person CBTI sessions, CBTI delivered through a digital app supervised by a clinician, or their usual medical care. Participants will be assessed before the six-week treatment, immediately after it ends, and again three months later. Researchers will look at changes in sleep, post-concussion symptoms, mental health, and cognitive functioning to determine whether either form of CBTI is more effective than standard care.
This research suggests that testing two ways to deliver CBTI — in person and digitally — could help identify scalable solutions for a treatment that is currently under-used in military settings. If CBTI proves effective in this population, it could lead to better sleep treatment options being integrated into military TBI care, potentially supporting faster recovery and maintained combat readiness for service members.
Germain A, Wolfson M, Espejo E, Byrd A, Jurick S, Hungerford L, et al.. (2026). Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial.. Trials. https://doi.org/10.1186/s13063-026-09483-z