Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2023-04-30

Brief Summary

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This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members.

The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.

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Detailed Description

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Traumatic brain injury (TBI) represents a major health problem in United States military service members. Mild traumatic brain injury, also called "concussion", accounts for approximately 90% of the overall cases of TBI. Mild TBI (mTBI) is associated with various debilitating symptoms, such as headache, mood disorders, and sleep alterations. A high percentage of service members and veterans with suspected or confirmed mTBI are also diagnosed with insomnia or other sleep disorders.

In-person cognitive behavioral therapy for insomnia (CBT-I) has been documented as an effective therapy for treating insomnia. However, implementation within the Military Healthcare System (MHS) has been lacking due to lack of appropriately trained practitioners. Additionally, patients may overlook in-person therapy due to significant time commitment.

This study is a double-blind, randomized, controlled clinical trial to assess internet-guided CBT-I in military service members with insomnia and mTBI. The primary outcome measure for efficacy is the Insomnia Severity Index (ISI) with secondary cross-validation using the Pittsburgh Sleep Quality Index (PSQI). Approximately 200 participants will be randomized to treatment or control groups. Participants receiving active CBT-I will follow a 9-week internet-guided program requiring daily follow-up through an online portal that may be accessed via computer or phone. Participants in the control group will also receive access to an online portal for 9 weeks.

Primary analysis is percent improvement in severity symptoms assessed pre- and post-treatment. Secondary analysis is percent retained improvement in severity of symptoms assessed post-treatment and long-term follow-up at 6 months.

Secondary outcome measures will capture a variety of known and suspected insomnia precursors, predictors, or correlates and functional outcomes.

Conditions

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Insomnia Chronic Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active CBT-I

Internet-guided cognitive behavioral therapy

Group Type EXPERIMENTAL

Sleep Healthy Using the Internet (SHUTi)

Intervention Type DEVICE

Cognitive behavioral therapy delivered via internet-guided program customized for military service members

Control

Education control program

Group Type OTHER

Education Control Program

Intervention Type OTHER

Online portal designed to inform participants about healthy lifestyle activities and general insomnia information

Interventions

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Sleep Healthy Using the Internet (SHUTi)

Cognitive behavioral therapy delivered via internet-guided program customized for military service members

Intervention Type DEVICE

Education Control Program

Online portal designed to inform participants about healthy lifestyle activities and general insomnia information

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-64
* Service member or veteran
* Ability to provide electronic informed consent and follow study-related instructions
* Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5
* History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener
* Reliable access to a telephone and the Internet via their computer or smartphone
* Stable regimen of medications for sleep or potentially affecting sleep over prior 1 month as confirmed by clinical history review

Exclusion Criteria

* Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care
* Life expectancy of \<6 months
* Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.)
* Self-reported history of moderate to severe substance use disorders with the exception of nicotine
* Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I
* Routine irregular work schedules or sleep patterns defined as shift work greater than 1 day per week
* Any other considerations that in the view of the principal investigator may adversely affect patient safety, participation, or scientific validity of the data being collected

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No