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

Study Overview
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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.

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.

Official Title
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A Randomized, Controlled, Blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury

Conditions
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Insomnia Chronic, Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: Sleep Healthy Using the Internet (SHUTi)
* Other: Education Control Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active CBT-I<br>Internet-guided cognitive behavioral therapy | Device: Sleep Healthy Using the Internet (SHUTi)<br>* Cognitive behavioral therapy delivered via internet-guided program customized for military service members<br>|
| Other: Control<br>Education control program | Other: Education Control Program<br>* Online portal designed to inform participants about healthy lifestyle activities and general insomnia information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score. | Baseline and 9 weeks | 
| Insomnia Severity Index (ISI) | Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 (PHQ-9) | Comparison of changes in PHQ-9 scores from baseline to post-intervention | Baseline and 9 weeks | 
| Patient Health Questionnaire 9 (PHQ-9) | Comparison of changes in PHQ-9 scores from baseline to post-intervention | Baseline and 3 months | 
| PTSD Checklist for DSM-5 (PCL-5) | Comparison of changes in PCL-5 scores from baseline to post-intervention | Baseline and 9 weeks | 
| PTSD Checklist for DSM-5 (PCL-5) | Comparison of changes in PCL-5 scores from baseline to post-intervention | Baseline and 3 months | 
| Migraine Disability Assessment (MIDAS) | Comparison of changes in MIDAS scores from baseline to post-intervention | Baseline and 9 weeks | 
| Migraine Disability Assessment (MIDAS) | Comparison of changes in MIDAS scores from baseline to post-intervention | Baseline and 3 months | 
| Pittsburgh Sleep Quality Index (PSQI) | Comparison of changes in PSQI scores from baseline to post-intervention | Baseline and 9 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | Comparison of changes in PSQI scores from baseline to post-intervention | Baseline and 3 months | 
| Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A) | Comparison of changes in PSQI-A scores from baseline to post-intervention | Baseline and 9 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A) | Comparison of changes in PSQI-A scores from baseline to post-intervention | Baseline and 3 months | 
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Comparison of changes in FACIT-F scores from baseline to post-intervention | Baseline and 9 weeks | 
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Comparison of changes in FACIT-F scores from baseline to post-intervention | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Insomnia, Concussion, Mild Traumatic Brain Injury