CClinicalTrials.gg
CompletedNCT03261674Updated Oct 31, 2024Results posted

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

An interventional study of CBT-I and ABT-I in Insomnia and Traumatic Brain Injury, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Insomnia
  • Traumatic Brain Injury

Keywords

  • Insomnia
  • Traumatic Brain Injury
  • Cognitive Behavioral Therapy
  • Veterans
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    CBTI

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

    Behavioral: CBT-I

  • Experimental
    ABTI

    Arousal-Based Therapy for Insomnia (ABT-I)

    Behavioral: ABT-I

Interventions

  • BehavioralCBT-I

    Cognitive Behavioral Therapy for Insomnia (CBT-I)

  • BehavioralABT-I

    Arousal-Based Therapy for Insomnia (ABT-I)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline at week 8 after treatment

06

Results

Posted Oct 31, 2024

Participant flow

Participant flow — Overall Study
MilestoneCBTIABTI
Started5654
Completed4739
Not completed915
Withdrew: Lost to follow-up67
Withdrew: Protocol violation14
Withdrew: Withdrawal by subject14
Withdrew: Physician decision10

Outcome measures

PrimaryInsomnia 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.

Time frame:
Change from baseline at week 8 after treatment
Reported as:
Mean · Units on a scale
Insomnia Severity Index (ISI)
Units on a scaleCBTIABTI
Insomnia Severity Index (ISI)-9.7 ± 4.42-4.72 ± 4.5

Adverse events

Collected over Adverse Events were collected at weeks 1, 2, 3, 4, 5, 6, 7, 8 and at 6 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CBTI0/47 (0%)0/47 (0%)0/47 (0%)
ABTI0/39 (0%)0/39 (0%)0/39 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CBTIABTITotal
<=18 years000
Between 18 and 65 years514394
>=65 years51116
Age, Continuous
Age, Continuous(years)CBTIABTITotal
Mean49.95 ± 10.3252.56 ± 12.6051 ± 11.52
Sex: Female, Male
Sex: Female, Male(Participants)CBTIABTITotal
Female151732
Male413778
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CBTIABTITotal
Hispanic or Latino5712
Not Hispanic or Latino494796
Unknown or Not Reported202
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CBTIABTITotal
American Indian or Alaska Native224
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American167
White473885
More than one race4610
Unknown or Not Reported022
07

Study locations

1 site
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, California 94304-1207, United States
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Sep 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

09

Registry details

Key details

Study ID
NCT03261674
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Jun 28, 2018
Primary completion
Sep 30, 2023
Completion
Apr 25, 2024
Results posted
Oct 31, 2024
Last update
Oct 31, 2024

Study contacts

Ansgar J. Furst, PhD
principal investigator · VA Palo Alto Health Care System, Palo Alto, CA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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