CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms (NCT05663034) | Clinical Trial Compass
RecruitingNot Applicable
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
United States360 participantsStarted 2024-05-10
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
. \>18 years of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two talk-based therapies — CBT-I and mindfulness-based therapy — for insomnia after a brain injury, so could you help me understand which of these approaches might be a better fit given my specific TBI history and current symptoms?
2Since this trial is listed as Phase NA, meaning it's not a traditional drug trial, what does that mean for what's already known about the safety of these two therapy types for people with TBI-related memory or cognitive difficulties?
3The trial is measuring changes in insomnia severity using a standardized questionnaire called the ISI, but I also have post-traumatic stress symptoms — will my PTSD be treated as part of this study, or is it mainly focused on sleep?
4Given that I may have memory impairment as part of my TBI, how demanding are the therapy sessions and any homework or practice involved, and is my doctor aware of whether that workload is realistic for where I am right now?
5Before considering this trial, is there a standard-of-care treatment for TBI-related insomnia that I should try first, or does my doctor think a research study like this one might actually be a reasonable first step for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Insomnia severity as assessed by the insomnia severity index (ISI)
Timeframe: At the end of treatment, and 2-, 6- and 12-weeks post treatment
. History of neurological diseases other than TBI and not attributable to TBI
. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 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.