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Trial record 17 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND traumatic brain injury (TBI)

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03261674
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 on the Insomnia Severity Index (ISI) 10
  • 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 whose sleep apnea is too severe for this project (AHI > 15) will be referred for clinical treatment or other research protocols on sleep apnea.
  • 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

  • Patient Health Questionnaire (PHQ) score >14
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261674


Contacts
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Contact: Rayma Williams, BS (650) 852-3426 rayma.williams@va.gov
Contact: Lien-Lien L Wu, MS (650) 852-3426 lien-lien.wu@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Ansgar J Furst, PhD    650-493-5000 ext 68652    Ansgar.Furst@va.gov   
Contact: Stacy Moeder, MHA MBA    (650) 493-5000 ext 63316    Stacy.Moeder@va.gov   
Principal Investigator: Ansgar J. Furst, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ansgar J. Furst, PhD VA Palo Alto Health Care System, Palo Alto, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03261674     History of Changes
Other Study ID Numbers: B2319-I
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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
Keywords provided by VA Office of Research and Development:
Insomnia
Traumatic Brain Injury
Cognitive Behavioral Therapy
Veterans
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sleep Initiation and Maintenance Disorders
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders