CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Recruiting · NCT05663034 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
- 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.
Exclusion criteria
- 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.
Where it is running
5 locations listed across 4 US states.
- Intrepid Spirit Center - Eglin Air Force Base - Eglin Air Force Base, Florida, United States
- Naval School Explosive Ordance Disposal - Eglin Air Force Base - Eglin Air Force Base, Florida, United States
- Walter Reed National Medical Military Center - Bethesda, Maryland, United States
- Womack Army Medical Center - Fort Bragg, North Carolina, United States
- Madigan Army Medical Center - Fort Lewis, Washington, United States