- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261674
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
November 16, 2023 updated by: VA Office of Research and Development
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
Active, not recruiting
Conditions
Intervention / Treatment
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)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rayma Williams, BS
- Phone Number: (650) 852-3426
- Email: rayma.williams@va.gov
Study Contact Backup
- Name: Ansgar J Furst, PhD
- Phone Number: 68652 (650) 493-5000
- Email: Ansgar.Furst@va.gov
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBTI
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
|
Cognitive Behavioral Therapy for Insomnia (CBT-I)
|
Experimental: ABTI
Arousal-Based Therapy for Insomnia (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)
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.
|
Change from baseline at week 8 after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ansgar J. Furst, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2018
Primary Completion (Actual)
September 30, 2023
Study Completion (Estimated)
April 30, 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)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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