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Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377009
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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.


Condition or disease Intervention/treatment Phase
Insomnia Chronic Mild Traumatic Brain Injury Device: Sleep Healthy Using the Internet (SHUTi) Other: Education Control Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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

Control
Education control program
Other: Education Control Program
Online portal designed to inform participants about healthy lifestyle activities and general insomnia information




Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 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.

  2. Insomnia Severity Index (ISI) [ Time Frame: Baseline and 3 months ]
    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 Outcome Measures :
  1. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in PHQ-9 scores from baseline to post-intervention

  2. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in PHQ-9 scores from baseline to post-intervention

  3. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in PCL-5 scores from baseline to post-intervention

  4. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in PCL-5 scores from baseline to post-intervention

  5. Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in MIDAS scores from baseline to post-intervention

  6. Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in MIDAS scores from baseline to post-intervention

  7. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in PSQI scores from baseline to post-intervention

  8. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in PSQI scores from baseline to post-intervention

  9. Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in PSQI-A scores from baseline to post-intervention

  10. Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in PSQI-A scores from baseline to post-intervention

  11. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: Baseline and 9 weeks ]
    Comparison of changes in FACIT-F scores from baseline to post-intervention

  12. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: Baseline and 3 months ]
    Comparison of changes in FACIT-F scores from baseline to post-intervention


Other Outcome Measures:
  1. Sleep outcomes [ Time Frame: 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

  2. Blinding efficacy [ Time Frame: 3 months ]
    Assess investigator blinding efficacy as reflected by mid-intervention and post-intervention questionnaires

  3. Concurrent Medications [ Time Frame: 9 weeks; 3 months ]
    Assess concurrent medications and correlation with intervention efficacy

  4. Participant Expectations [ Time Frame: Baseline; 9 weeks; 3 months ]
    Assess participant expectation of benefit and blinding efficacy as reflected by pre-intervention and post-intervention questionnaires

  5. Participant satisfaction [ Time Frame: 3 months ]
    Assess participant satisfaction and help-seeking behavior as reflected by a 3-month follow-up questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377009


Contacts
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Contact: Molly Malarkey 301-456-5474 cnrm-ecbti@usuhs.edu

Locations
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United States, Maryland
Uniformed Services University Recruiting
Bethesda, Maryland, United States, 20817
Contact: Molly Malarkey       cnrm-ecbti@usuhs.edu   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Investigators
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Principal Investigator: David L Brody, MD, PhD Uniformed Services University of the Health Sciences
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT04377009    
Other Study ID Numbers: CNRM-02-9662
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.
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

URL: https://fitbir.nih.gov/content/access-data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Cognitive Behavioral Therapy
Insomnia
Concussion
Mild Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Sleep Initiation and Maintenance Disorders
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders