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

NCT04377009 | Completed FDA Device

• 1 other identifier: CNRM-02-9662
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Mild Traumatic Brain Injury

Keywords

Cognitive Behavioral Therapy; Insomnia; Concussion; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Patient Health Questionnaire 9 (PHQ-9)

  Baseline and 9 weeks

• Patient Health Questionnaire 9 (PHQ-9)

  Baseline and 3 months

• PTSD Checklist for DSM-5 (PCL-5)

  Baseline and 9 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  Baseline and 3 months

• Migraine Disability Assessment (MIDAS)

  Baseline and 9 weeks

Other Outcomes (5)

• Sleep outcomes

  9 weeks; 3 months

• Blinding efficacy

  3 months

• Concurrent Medications

  9 weeks; 3 months

Study Arms (2)

Active CBT-I

EXPERIMENTAL

Internet-guided cognitive behavioral therapy

Device: Sleep Healthy Using the Internet (SHUTi)

Control

OTHER

Education control program

Other: Education Control Program

Interventions

Sleep Healthy Using the Internet (SHUTi) DEVICE

Cognitive behavioral therapy delivered via internet-guided program customized for military service members

Active CBT-I

Education Control Program OTHER

Online portal designed to inform participants about healthy lifestyle activities and general insomnia information

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

Uniformed Services University

Bethesda, Maryland, 20817, United States

Location

Related Publications (1)

• Malarkey ME, Fu AJ, Mannan N, Shaw OM, Haight TJ, Cota MR, Jahed NC, Werner JK, Brody DL. Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2420090. doi: 10.1001/jamanetworkopen.2024.20090.

  PMID: 38980675 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Concussion

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• David L Brody, MD, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: July 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)