Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury

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).

Study Overview

• Status: Completed
• Conditions: Insomnia; Traumatic Brain Injury
• Intervention / Treatment: Behavioral: CBT-I; Behavioral: ABT-I

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System, Palo Alto, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.	Change from baseline at week 8 after treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ansgar J. Furst, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Veterans; Insomnia; Cognitive Behavioral Therapy; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: B2319-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No