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NCT05663034 · ClinicalTrials.gov registry record · NA

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

A NA study of Depression and Traumatic Brain Injury, sponsored by Johns Hopkins University.

Recruiting
Registry status
NA
Development phase
360
Enrollment target
5
Study locations

NCT05663034: Recruiting NA study of Depression and Traumatic Brain Injury, sponsored by Johns Hopkins University.

NCT05663034 is a NA study of Depression and Traumatic Brain Injury that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 360 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (54% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05663034, a NA study of Depression and Traumatic Brain Injury, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
NA
Development phase
360 participants
Enrollment target
5
Study locations

Study Summary

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Primary Outcome

Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms

Conditions Studied

Depression Traumatic Brain Injury Insomnia Sleep Concussion, Brain Memory Impairment Head Injury Cognitive Behavioral Therapy Post-traumatic Stress Brain Injury Traumatic Mild

Interventions

  • BEHAVIORAL Cognitive behavioral therapy for insomnia (CBT-I)
  • BEHAVIORAL Mindfulness-based treatment for insomnia (MBTI)

Study Locations (5)

Florida

  • Intrepid Spirit Center - Eglin Air Force Base - Eglin Air Force Base
  • Naval School Explosive Ordance Disposal - Eglin Air Force Base - Eglin Air Force Base

Maryland

  • Walter Reed National Medical Military Center - Bethesda

North Carolina

  • Womack Army Medical Center - Fort Bragg

Washington

  • Madigan Army Medical Center - Fort Lewis

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2024-05-10
Est. Completion 2026-09
Phase NA
Johns Hopkins University

1,448 total trials

What NCT05663034 shows while recruiting

NCT05663034 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (54% lower).

The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Cognitive behavioral therapy for insomnia (CBT-I) is the first listed.

NCT05663034 lists 5 locations in 4 states (Florida, Maryland, North Carolina).

Frequently Asked Questions

What is clinical trial NCT05663034 about?

NCT05663034 is a clinical study titled "CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms". This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia sym...

What is the current status of trial NCT05663034?

This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2024-05-10. Estimated completion is 2026-09.

What conditions does trial NCT05663034 study?

This clinical trial studies the following conditions: Depression, Traumatic Brain Injury, Insomnia, Sleep, Concussion, Brain.

What interventions are being tested in trial NCT05663034?

The interventions under investigation include: Cognitive behavioral therapy for insomnia (CBT-I) (BEHAVIORAL), Mindfulness-based treatment for insomnia (MBTI) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05663034?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05663034 being conducted?

This trial has 5 study locations across Florida, Maryland, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05663034's enrollment target sits among peer trials

360 118th of 679 higher than 560 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression 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

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More recruiting context for NCT05663034

Source: ClinicalTrials.gov NCT05663034, the US trial registry maintained by the National Library of Medicine. NCT05663034 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.