Clinical trial NCT04377009: Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI
Official title: A Randomized, Controlled, Blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Mild Traumatic Brain Injury
Keywords: Cognitive Behavioral Therapy
Insomnia
Concussion
Mild Traumatic Brain Injury
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: Center for Neuroscience and Regenerative Medicine (CNRM)
First posted: 2020-05-06
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline and 9 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline and 9 weeks
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline and 3 months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline and 9 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline and 3 months
measure: Migraine Disability Assessment (MIDAS)
timeFrame: Baseline and 9 weeks
measure: Migraine Disability Assessment (MIDAS)
timeFrame: Baseline and 3 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 9 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 3 months
measure: Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
timeFrame: Baseline and 9 weeks
measure: Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
timeFrame: Baseline and 3 months
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Baseline and 9 weeks
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Baseline and 3 months
Other outcomes:
measure: Sleep outcomes
timeFrame: 9 weeks; 3 months
measure: Blinding efficacy
timeFrame: 3 months
measure: Concurrent Medications
timeFrame: 9 weeks; 3 months
measure: Participant Expectations
timeFrame: Baseline; 9 weeks; 3 months
measure: Participant satisfaction
timeFrame: 3 months
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: David L Brody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: