Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03261674

Collaborator

(none)

120

Enrollment

Location

Arms

66.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Insomnia Traumatic Brain Injury	Behavioral: CBT-I Behavioral: ABT-I	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury

Actual Study Start Date :

Jun 28, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBTI Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)	Behavioral: CBT-I Cognitive Behavioral Therapy for Insomnia (CBT-I)
Experimental: ABTI Arousal-Based Therapy for Insomnia (ABT-I)	Behavioral: ABT-I Arousal-Based Therapy for Insomnia (ABT-I)

Arm

Intervention/Treatment

Experimental: CBTI

Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral: CBT-I

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Experimental: ABTI

Arousal-Based Therapy for Insomnia (ABT-I)

Behavioral: ABT-I

Arousal-Based Therapy for Insomnia (ABT-I)

Outcome Measures

Primary Outcome Measures

Insomnia Severity Index (ISI) [Change from baseline at week 8 after treatment]
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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