search
Back to results

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Primary Purpose

Insomnia, Traumatic Brain Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
ABT-I
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Traumatic Brain Injury, Cognitive Behavioral Therapy, Veterans

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBTI

ABTI

Arm Description

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

Arousal-Based Therapy for Insomnia (ABT-I)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2017
Last Updated
July 25, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03261674
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Traumatic Brain Injury
Keywords
Insomnia, Traumatic Brain Injury, Cognitive Behavioral Therapy, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBTI
Arm Type
Experimental
Arm Description
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arm Title
ABTI
Arm Type
Experimental
Arm Description
Arousal-Based Therapy for Insomnia (ABT-I)
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Intervention Description
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Type
Behavioral
Intervention Name(s)
ABT-I
Intervention Description
Arousal-Based Therapy for Insomnia (ABT-I)
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from baseline at week 8 after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ansgar J. Furst, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

We'll reach out to this number within 24 hrs