Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04377009 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.

Completed
Registry status
NA
Development phase
125
Enrollment target

NCT04377009: Completed NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.

NCT04377009 is a NA study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 125 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04377009, a NA study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.

COMPLETED
Registry status
NA
Development phase
125 participants
Enrollment target

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.

Primary Outcome

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.

Interventions

  • DEVICE Sleep Healthy Using the Internet (SHUTi)
  • OTHER Education Control Program

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2020-07-07
Est. Completion 2023-04-30
Phase NA

What the finished NCT04377009 record still lists

NCT04377009 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Sleep Healthy Using the Internet (SHUTi) is the first listed.

NCT04377009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04377009 about?

NCT04377009 is a clinical study titled "Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI". 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...

What is the current status of trial NCT04377009?

This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2020-07-07. Estimated completion is 2023-04-30.

What interventions are being tested in trial NCT04377009?

The interventions under investigation include: Sleep Healthy Using the Internet (SHUTi) (DEVICE), Education Control Program (OTHER).

Who is sponsoring clinical trial NCT04377009?

This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04377009's enrollment target sits among peer trials

125 753rd of 2000 higher than 1,243 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02717039 · 125 participants

    Pharmacogenomics of Heparin-Induced Thrombocytopenia

  • NCT02763033 · 125 participants · Phase 2

    Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

  • NCT02793999 · 125 participants

    Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

  • NCT03003299 · 125 participants · NA

    PARTNER 3 Trial - Aortic Valve-in-Valve

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04377009, the US trial registry maintained by the National Library of Medicine. NCT04377009 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.