Insomnia Chronic, Mild Traumatic Brain Injury
Conditions
Keywords
Cognitive Behavioral Therapy, Insomnia, Concussion, Mild Traumatic Brain Injury
Brief summary
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
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.
Interventions
Cognitive behavioral therapy delivered via internet-guided program customized for military service members
OTHEREducation Control Program
Online portal designed to inform participants about healthy lifestyle activities and general insomnia information
Sponsors
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline and 9 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | Baseline and 9 weeks | Comparison of changes in PCL-5 scores from baseline to post-intervention |
| Patient Health Questionnaire 9 (PHQ-9) | Baseline and 9 weeks | Comparison of changes in PHQ-9 scores from baseline to post-intervention |
| Migraine Disability Assessment (MIDAS) | Baseline and 9 weeks | Comparison of changes in MIDAS scores from baseline to post-intervention |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline and 9 weeks | Comparison of changes in PSQI scores from baseline to post-intervention |
| Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A) | Baseline and 9 weeks | Comparison of changes in PSQI-A scores from baseline to post-intervention |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline and 9 weeks | Comparison of changes in FACIT-F scores from baseline to post-intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concurrent Medications | 9 weeks; 3 months | Assess concurrent medications and correlation with intervention efficacy |
| Participant Expectations | Baseline; 9 weeks; 3 months | Assess participant expectation of benefit and blinding efficacy as reflected by pre-intervention and post-intervention questionnaires |
| Participant satisfaction | 3 months | Assess participant satisfaction and help-seeking behavior as reflected by a 3-month follow-up questionnaire |
| Blinding efficacy | 3 months | Assess investigator blinding efficacy as reflected by mid-intervention and post-intervention questionnaires |
| Sleep outcomes | 9 weeks; 3 months | Assess changes in sleep outcomes and calculated sleep efficiency: bed time, sleep onset latency, number of awakenings, total duration of awakenings, wake time, arising time, daytime naps, soundness of sleep, sleep quality, sleep medication and alcohol use |
Countries
United States
Outcome results
None listed