CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Официальное название

CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Обзор

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).

Подробное описание

This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia. A cohort of n=360 adults with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia will be randomized to receive either telemedicine-delivered CBT-I or MBTI. Consistent with previous scientific literature, the interventions will be standardized and six sessions in length. All participants will wear an actigraph wrist monitor throughout the course of the project. All participants will also complete electronic sleep diaries throughout the course of the project. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, ambulatory EEG sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment (12- and 24-weeks post randomization, respectively). The primary outcome is insomnia severity (ISI) and secondary outcomes are pre-sleep arousal, and depressive symptoms (PSAS; Patient Health Questionnaire (PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).

Вмешательства

• Поведенческое Mindfulness-based treatment for insomnia (MBTI)
  A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia
• Поведенческое Cognitive behavioral therapy for insomnia (CBT-I)
  Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.

Первичные конечные точки

• Change in Insomnia severity as assessed by the insomnia severity index (ISI) [Срок оценки: At the end of treatment, and 2-, 6- and 12-weeks post treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Intrepid Spirit Center - Eglin Air Force Base — Eglin Air Force Base
• Naval School Explosive Ordance Disposal - Eglin Air Force Base — Eglin Air Force Base
• Walter Reed National Medical Military Center — Bethesda
• Womack Army Medical Center — Fort Bragg
• Madigan Army Medical Center — Fort Lewis

Идентификаторы

NCT: NCT05663034 · IRB00356930 · 141686

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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