Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    120
  • sponsor
    VA Office of Research and Development
Updated on 24 March 2022
diabetes
depression
behavior therapy
traumatic brain injury
post-traumatic stress disorder
post-concussion syndrome
cognitive behavioral therapy for insomnia

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).

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).

Details
Condition Insomnia, Traumatic Brain Injury
Treatment CBT-I, CBTI, DTI, ABT-I
Clinical Study IdentifierNCT03261674
SponsorVA Office of Research and Development
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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 according to DUKE/DSM-5 criteria
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 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
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 or TCogs < 23
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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