Depression Clinical Trial
Official title:
CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for 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 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 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
Status | Recruiting |
Enrollment | 360 |
Est. completion date | September 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBI 2. Mild to moderate TBI severity at time of injury based on review of medical records 3. Time duration since injury >3 weeks 4. Endorse insomnia symptoms (Insomnia Severity Index [ISI] score > 9) 5. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2149) 6. 18 years of age or greater 7. Access to and ability and to use computer Exclusion Criteria: 1. History of neurological diseases other than TBI and not attributable to TBI 2. Known history of intellectual or developmental disability 3. Communication difficulties or inability to speak English 4. Sleep apnea [apnea hypopnea index (AHI) >15; individuals with mild apnea (AHI > 5 and <14.9) will be informed, but allowed to participate]. Patients 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. Patients using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study. |
Country | Name | City | State |
---|---|---|---|
United 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 | Womack Army Medical Center | Fort Bragg | North Carolina |
United States | Madigan Army Medical Center | Fort Lewis | Washington |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Department of Defense Congressionally Directed Medical Research Program |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Neurocognitive functioning as assessed by the Automated Neuropsychological Assessment Metrics (ANAM) | Neurocognitive functioning measured by Automated Neuropsychological Assessment Metrics (ANAM) | At the end of treatment, and 6- and 12-weeks post treatment | |
Primary | Change in Insomnia severity as assessed by the insomnia severity index (ISI) | Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms | At the end of treatment, and 6- and 12-weeks post treatment | |
Secondary | Change in Pre-sleep Arousal as assessed by the Pre-sleep Arousal Scale (PSAS) | Pre-sleep Arousal measured by Pre-sleep Arousal Scale (PSAS); Score range: 16-80; Higher scores are associated with greater pre-sleep arousal. | At the end of treatment, and 6- and 12-weeks post treatment | |
Secondary | Change in Depressive Symptoms as assessed by the Patient Health Questionnaire-8 Item (PHQ-8) | Depressive Symptoms measured by the Patient Health Questionnaire-8 Item (PHQ-8); Score range: 0-24; Higher scores are associated with greater depressive symptoms | At the end of treatment, and 6- and 12-weeks post treatment |
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