Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI
Condition: Insomnia Chronic; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Sleep Healthy Using the Internet (SHUTi); Education Control Program
Intervention type(s): Device; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; Insomnia; Concussion; Mild Traumatic Brain Injury