Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain
Injury (TBI) and often associated with extensive prescription of sleeping medications.
Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of
abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to
medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy
for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).

Inclusion Criteria:

- Male or female chronic (> 3 months since injury) mTBI Veterans of any racial or ethnic
group

- Independent Living (not in nursing home or VA Extended Care facility)

- Current chronic (3 months) subjective complaint of insomnia on the Insomnia Severity
Index (ISI) 10

- Subjects with PTSD will be included in this study as long as they do not meet criteria
for depression described below

- Use of CNS active medications that could significantly impact sleep or alertness is
allowed as long as the dose, timing, and formulation are stable (3 weeks)

- Stable adult onset diabetes, controlled with insulin, oral medications or diet is
acceptable

Exclusion Criteria:

Sleep-Related

- Excessive caffeine consumption (5 cups of coffee per day) and unable to reduce to 3
cups before lunch a day for 3 weeks prior to treatment

- Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea) and
those with responses suggestive of high risk for sleep apnea, will be referred to
Pulmonary Medicine for standard clinical screening including polysomnography.

- Subjects whose sleep apnea is too severe for this project (AHI > 15) will be referred
for clinical treatment or other research protocols on sleep apnea.

- Subjects who have Obstructive Sleep Apnea (OSA) but who are adherent to CPAP will not
be excluded

- Subjects working a rotating shift or an unconventional daytime shift (ending after
1700 h) will be ineligible

Neuropsychiatric

- Patient Health Questionnaire (PHQ) score >14

- Current or lifetime history of a psychiatric disorder with primary psychotic features

- Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation

- Current exposure to trauma, or exposure to trauma in the past 3 months

- Current or within the past 30 days: drug abuse or dependence (except nicotine)

- Current or expected cognitive behavior therapy for another condition (e.g. depression)

- More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before
bedtime

- Presence of any acute or unstable psychiatric condition(s) that requires referral for
treatment

- Folstein Mini-Mental State Exam (MMSE) < 24

Medical

- Acute or unstable chronic illness, including but not limited to:

- uncontrolled thyroid disease

- kidney

- prostate or bladder conditions causing excessively frequent urination (> 3 times
per night)

- medically unstable congestive heart failure

- angina

- other severe cardiac illness as defined by treatment regimen changes in the prior
3 months

- stroke with serious sequelae

- cancer if < 1 year since end of treatment

- asthma

- emphysema

- or other severe respiratory diseases uncontrolled with medications

- neurological disorders such as Alzheimer's disease, Parkinson's disease and
unstable epilepsy as defined by treatment regimen changes in the prior 3 months

- Unstable adult onset diabetes will be excluded