CBT-I for Veterans With TBI

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.

Inclusion Criteria:

1. OEF/OIF/OND Veteran ages 18-55.

2. Documented history of mild TBI (documented in the medical record and where possible
from the VA TBI second-level evaluation)

1. Loss of consciousness 30 minutes

2. Post-traumatic amnesia 1 day

3. At least 3 months post-TBI.

4. A diagnosis of insomnia classified as:

1. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria that
include: trouble falling asleep, staying asleep, waking too early, and/or
non-restorative sleep with accompanied daytime impairment in functioning for > 3
months, occurring at least 3 nights per week.

2. Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score >5
and Insomnia Severity Index score >7 at intake.

5. No prior exposure to and/or treatment with CBT-I within the past 2 years.

6. Must be stable on medication regimen for at least 1 month prior to enrollment in
study.

Exclusion Criteria:

1. History of a neurological disorder (besides TBI), dementia, or premorbid IQ <70.

2. Schizophrenia, psychotic disorder, and/or bipolar disorder.

3. Evidence of suicidality more than "low risk" as determined by the VA Comprehensive
Suicide Risk Assessment (CSRA).

4. Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or
periodic limb movements)

5. Alcohol and/or substance abuse within the past 30 days.