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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status

Completed

Conditions

Mild Traumatic Brain Injury

Insomnia Chronic

Treatments

Device: Sleep Healthy Using the Internet (SHUTi)

Other: Education Control Program

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04377009

CNRM-02-9662

Details and patient eligibility

About

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.

Full description

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.

Enrollment

125 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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