Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261674
• Other study ID #: B2319-I
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: April 25, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 25, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• CBT-I
Cognitive Behavioral Therapy for Insomnia (CBT-I)
• ABT-I
Arousal-Based Therapy for Insomnia (ABT-I)

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)	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.	Change from baseline at week 8 after treatment