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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03261674
Other study ID # B2319-I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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