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New treatment option for Traumatic Brain Injury
Official title CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
ClinicalTrials.gov ID: NCT05663034
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Current or former member of the uniform services
- Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
- Time duration since traumatic brain injury (TBI) injury \>90 days
- Insomnia symptom duration \>90 days
- Endorse insomnia symptoms (Insomnia Severity Index [ISI] score \> 10)
You likely can't join if
- History of neurological diseases other than TBI and not attributable to TBI
- Sleep apnea [apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \ 4 hours/night 21/30 consecutive days) and agree to continue...
- Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.
See the full eligibility criteria
- Current or former member of the uniform services
- Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
- Time duration since traumatic brain injury (TBI) injury \>90 days
- Insomnia symptom duration \>90 days
- Endorse insomnia symptoms (Insomnia Severity Index [ISI] score \> 10)
- Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
- \>18 years of age
- Access to and ability and to use computer.
- History of neurological diseases other than TBI and not attributable to TBI
- Sleep apnea [apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \ 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.
- Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.
The study team makes the final eligibility decision.
Where it's taking place
- Eglin Air Force Base, Florida, United States
- Bethesda, Maryland, United States
- Fort Bragg, North Carolina, United States
- Fort Lewis, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eglin Air Force Base, Florida, United States; Bethesda, Maryland, United States; Fort Bragg, North Carolina, United States; Fort Lewis, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.