Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)

Официальное название

Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)

Обзор

This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are: 1. Does CBT-I positively impact symptoms of mTBI? 2. Does CBT-I improve functional performance in individuals with mTBI?

Подробное описание

Cognitive behavioral therapy for insomnia (CBT-I) is an evidence-based intervention that has demonstrated significant results in various populations. CBT-I is a structured and goal-oriented approach that addresses both unhelpful thoughts and maladaptive behaviors contributing to poor sleep. CBT-I includes several components, such as behavioral strategies that aim to change habits disrupting sleep architecture and cognitive techniques targeting maladaptive beliefs about sleep. However, limited research has examined the use of this intervention among individuals with mild traumatic brain injury (mTBI), particularly regarding its impact on their ability to perform daily life activities. This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance.

Вмешательства

• Поведенческое Cognitive behavioral Therapy for insomnia (CBT-I)
  CBT-I is an evidence-based psychotherapy designed to address insomnia. This structured and multifaceted intervention aims to help individuals who have trouble falling asleep or/ and staying asleep during the night. CBT-I is a multi-component treatment that includes two core parts: behavioral and cognitive aspects. It consists of Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), and Cognitive Therapy (CT) with an emphasis on Cognitive restructuring, as well as Psychoeducation and S

Первичные конечные точки

• The expanded consensus sleep diary (CSD) [Срок оценки: Through study completion, an average of 10 weeks.]
• Insomnia Severity Index (ISI) [Срок оценки: Baseline (Day 1)]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (Day 1)]
• Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline (Day 1)]
• Canadian Occupation Performance Measure (COPM) [Срок оценки: Baseline (day 1)]
• Activity Card Sort (ACS) [Срок оценки: Baseline (day 1)]
• Feasibility of Intervention Measure (FIM) [Срок оценки: Post intervention (final study visit)]
• Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: Post intervention (final study visit)]
• Insomnia Severity Index (ISI) [Срок оценки: Post intervention (final study visit)]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Post intervention (final study visit)]

Вторичные конечные точки (12)

• Dysexecutive Questionnaire (DEX) [Срок оценки: Baseline (day 1)]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Baseline (day 1)]
• Fatigue Severity Scale (FSS) [Срок оценки: Baseline (day 1)]
• Beck's Depression Inventory (BDI) [Срок оценки: Baseline (day 1)]
• Depression Anxiety Stress Scale (DASS) [Срок оценки: Baseline (day 1)]
• Quality of Life after Brain Injury (QOLIBRI) [Срок оценки: Baseline (day 1)]
• Dysexecutive Questionnaire (DEX) [Срок оценки: Post intervention (final study visit)]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Post intervention (final study visit)]
• Fatigue Severity Scale (FSS) [Срок оценки: Post intervention (final study visit)]
• Beck's Depression Inventory (BDI) [Срок оценки: Post intervention (final study visit)]
• Depression Anxiety Stress Scale (DASS) [Срок оценки: Post intervention (final study visit)]
• Quality of Life after Brain Injury (QOLIBRI) [Срок оценки: Post intervention (final study visit)]

Критерии участия

Критерии включения

• A history of mTBI documented by a physician and sleep problems for more than 4 weeks
• A score ≥ 10 on the Insomnia Severity Index (ISI)
• Speak, read, and write English

Критерии исключения

• History of other neurological or psychological conditions
• Patient Health Questionnaire-9 (PHQ-9) score higher than 20 (severe depressive symptoms)
• Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms)
• Montreal Cognitive Assessment (MoCA) score less than 24

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Missouri-Columbia — Columbia

Публикации

• Boone AE, Henderson WL, Zenoozi S. Surveying the Landscape of Persistent Concussive Symptoms in Adults Through an Occupational Lens. Am J Occup Ther. 2024 Mar 1;78(2):7802180190. doi: 10.5014/ajot.2024.050405. PMID 38373065

Идентификаторы

NCT: NCT07385105 · 2131848

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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