CBT-I for Veterans With TBI
Condition: Insomnia; Traumatic Brain Injury
MeSH terms: Brain Injuries; Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have
      suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury
      symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI
      patients has the potential to exacerbate other symptoms, delay recovery, and negatively
      affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby
      decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has
      been shown to be an effective evidence-based treatment for insomnia, there are no published
      randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I
      in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to
      provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who
      have suffered mTBI.
    

Detailed description: 
      This VA Rehabilitation Research and Development Career Development Award (CDA-2) proposal is
      designed to significantly advance the application of Behavioral Sleep Medicine practices in
      the treatment of Veterans seen in the VA Healthcare System, especially those recovering from
      traumatic brain injury (TBI). TBI has been deemed the "signature wound" of the Iraq and
      Afghanistan Wars, occurring in about 19.5% of Operation Enduring Freedom/Operation Iraqi
      Freedom/Operation New Dawn (OEF/OIF/OND) service members. For many Veterans, mild traumatic
      brain injury (mTBI) can be associated with persistent post-concussive symptoms, especially
      sleep disturbances. Sleep disturbances are among the most frequent complaints following mTBI,
      with studies suggesting that over 93% of Veterans who experienced brain injuries develop
      chronic sleep problems. Of the sleep disturbances diagnosed in this patient population the
      most common is insomnia, observed in over 50% of patients. Chronic and untreated insomnia is
      known to be associated with and/or increase risk for psychiatric problems, suicidal ideation,
      and unhealthy lifestyles (e.g., alcohol/drug abuse), lead to poorer physical health,
      disruption in major social and occupational responsibilities, and decreased quality of life,
      and may generally contribute to the persistence of post-concussive symptoms beyond the
      expected period of recovery. As such, treatment of sleep disturbance represents an essential
      component of Veteran care, one which may be particularly beneficial for Veterans with history
      of mTBI who commonly present to the clinic with complex multi-symptom concerns.

      To address this important clinical issue, the proposed randomized clinical trial (RCT) will
      attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) versus a
      Sleep Education control in Veterans with insomnia and a history of mTBI. CBT-I is recommended
      by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been
      adopted by the VA within an Evidence Based Practice roll-out program. Despite the acceptance
      of CBT-I as a first line treatment for sleep disturbance, there are no published RCTs
      evaluating CBT-I in mTBI patient populations. Therefore, this proposed investigation will
      address this gap in the literature by assessing the efficacy of CBT-I in Veterans with
      history of head injury.
    

Intervention name(s): Cognitive-Behavioral Therapy for Insomnia; Sleep Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.; Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.
Other intervention name(s): CBT-I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Injury, Brain, Traumatic Mild