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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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2026-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05663034
The ClinicalTrials.gov registry entry for NCT05663034 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (54% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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