Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI

Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI

A Randomized, Controlled, Blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury

Uniformed Services University of the Health Sciences, Center for Neuroscience and Regenerative Medicine (CNRM)

This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members. The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.

Traumatic brain injury (TBI) represents a major health problem in United States military service members. Mild traumatic brain injury, also called "concussion", accounts for approximately 90% of the overall cases of TBI. Mild TBI (mTBI) is associated with various debilitating symptoms, such as headache, mood disorders, and sleep alterations. A high percentage of service members and veterans with suspected or confirmed mTBI are also diagnosed with insomnia or other sleep disorders. In-person cognitive behavioral therapy for insomnia (CBT-I) has been documented as an effective therapy for treating insomnia. However, implementation within the Military Healthcare System (MHS) has been lacking due to lack of appropriately trained practitioners. Additionally, patients may overlook in-person therapy due to significant time commitment. This study is a double-blind, randomized, controlled clinical trial to assess internet-guided CBT-I in military service members with insomnia and mTBI. The primary outcome measure for efficacy is the Insomnia Severity Index (ISI) with secondary cross-validation using the Pittsburgh Sleep Quality Index (PSQI). Approximately 200 participants will be randomized to treatment or control groups. Participants receiving active CBT-I will follow a 9-week internet-guided program requiring daily follow-up through an online portal that may be accessed via computer or phone. Participants in the control group will also receive access to an online portal for 9 weeks. Primary analysis is percent improvement in severity symptoms assessed pre- and post-treatment. Secondary analysis is percent retained improvement in severity of symptoms assessed post-treatment and long-term follow-up at 6 months. Secondary outcome measures will capture a variety of known and suspected insomnia precursors, predictors, or correlates and functional outcomes.

Cognitive behavioral therapy delivered via internet-guided program customized for military service members

Online portal designed to inform participants about healthy lifestyle activities and general insomnia information

Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.

Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.

Assess changes in sleep outcomes and calculated sleep efficiency: bed time, sleep onset latency, number of awakenings, total duration of awakenings, wake time, arising time, daytime naps, soundness of sleep, sleep quality, sleep medication and alcohol use

Assess investigator blinding efficacy as reflected by mid-intervention and post-intervention questionnaires

Assess participant expectation of benefit and blinding efficacy as reflected by pre-intervention and post-intervention questionnaires

Assess participant satisfaction and help-seeking behavior as reflected by a 3-month follow-up questionnaire

Inclusion Criteria: Age 18-64 Service member or veteran Ability to provide electronic informed consent and follow study-related instructions Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5 History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener Reliable access to a telephone and the Internet via their computer or smartphone Stable regimen of medications for sleep or potentially affecting sleep over prior 1 month as confirmed by clinical history review Exclusion Criteria: Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care Life expectancy of <6 months Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.) Self-reported history of moderate to severe substance use disorders with the exception of nicotine Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I Routine irregular work schedules or sleep patterns defined as shift work greater than 1 day per week Any other considerations that in the view of the principal investigator may adversely affect patient safety, participation, or scientific validity of the data being collected

Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.

After study completion, data sets will be de-identified and shared with the repositories. De-identified data sets will be stored in the repositories indefinitely.

Access to the CNRM Data Repository will be determined b the CNRM Data Quality, Access, and Publication Committee. Investigators requesting access to the data will provide a list of investigators and collaborators who will have access to the data, documentation of Ethical Conduct of Research and Human Participants Protection Training, and documentation of Institutional Review Board Approval of the research project. Access to FITBIR will follow FITBIR Access Criteria