Clinical trial NCT03261674: Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Official title: Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Traumatic Brain Injury
Keywords: Insomnia
Traumatic Brain Injury
Cognitive Behavioral Therapy
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-08-25
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Male or female Veterans of any racial or ethnic group
* Independent Living (not in nursing home or VA Extended Care facility)
* Diagnosis of insomnia using the Duke structured interview
* Male or female chronic (\>3 months since injury) mild Traumatic Brain Injury (mTBI).
* 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.
* Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep disturbances is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
* Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use throughout the study.

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 working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) will be ineligible.

Neuropsychiatric

* Current or lifetime history of a psychiatric disorder with primary psychotic features.
* Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation.
* 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; and 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline at week 8 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Ansgar J. Furst, PhD
role: PRINCIPAL_INVESTIGATOR
References: