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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Insomnia Chronic
• Intervention / Treatment: Device: Sleep Healthy Using the Internet (SHUTi); Other: Education Control Program

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Uniformed Services University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep outcomes	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	9 weeks; 3 months
Blinding efficacy	Assess investigator blinding efficacy as reflected by mid-intervention and post-intervention questionnaires	3 months
Concurrent Medications	Assess concurrent medications and correlation with intervention efficacy	9 weeks; 3 months
Participant Expectations	Assess participant expectation of benefit and blinding efficacy as reflected by pre-intervention and post-intervention questionnaires	Baseline; 9 weeks; 3 months
Participant satisfaction	Assess participant satisfaction and help-seeking behavior as reflected by a 3-month follow-up questionnaire	3 months

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Uniformed Services University of the Health Sciences; Center for Neuroscience and Regenerative Medicine (CNRM)
• Investigators: Principal Investigator: David L Brody, MD, PhD, Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Concussion; Insomnia; Cognitive Behavioral Therapy; Mild Traumatic Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: CNRM-02-9662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
• IPD Sharing Time Frame: After study completion, data sets will be de-identified and shared with the repositories. De-identified data sets will be stored in the repositories indefinitely.

IPD Sharing Access Criteria

Access to the CNRM Data Repository will be determined b the CNRM Data Quality, Access, and Publication Committee. Investigators requesting access to the data will provide a list of investigators and collaborators who will have access to the data, documentation of Ethical Conduct of Research and Human Participants Protection Training, and documentation of Institutional Review Board Approval of the research project.

Access to FITBIR will follow FITBIR Access Criteria

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No