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

NCT04377009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-08-21

No results posted yet for this study

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

Interventions

DEVICE

Sleep Healthy Using the Internet (SHUTi)

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

OTHER

Education Control Program

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

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • David L Brody, MD, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2022-12-31
Completion
2023-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04377009 on ClinicalTrials.gov