Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The expanded consensus sleep diary (CSD)
研究概览
简要总结
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:
- Does CBT-I positively impact symptoms of mTBI?
- Does CBT-I improve functional performance in individuals with mTBI?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
15 mTBI cases who have sleep problems will receive CBT-I
We will achieve the study's aims with a single-group, pre-post design (n=15). Participants with physician-diagnosed mild traumatic brain injury who are experiencing sleep problems for more than four weeks will receive cognitive behavioral therapy for insomnia (CBT-I). Participants will engage in six one-hour, weekly CBT-I sessions delivered in a one-on-one format through the Zoom Video Conference. Participants will establish sleep-related goals. During the intervention session, the interventionist will address the cognitive and behavioral components of CBT-I, as well as relaxation techniques and sleep hygiene.
干预措施: Cognitive behavioral Therapy for insomnia (CBT-I) (Behavioral)
结局指标
主要结局
The expanded consensus sleep diary (CSD)
时间窗: Through study completion, an average of 10 weeks.
The expanded consensus sleep diary (CSD) is intended for use both in the morning and evening. Participants are required to complete the diary each morning upon waking and each evening before bedtime. The evening section records information about daytime activities, including caffeine, alcohol, medication use, and napping. The morning section captures details regarding the previous night's sleep.
Insomnia Severity Index (ISI)
时间窗: Baseline (Day 1)
The Insomnia Severity Index (ISI) is a seven-item questionnaire developed to assess the severity of insomnia symptoms. Scores range from 0 to 28, with higher scores indicating more severe symptoms.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline (Day 1)
The Pittsburgh Sleep Quality Index (PSQI) is a sleep questionnaire that evaluates seven primary components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over a one-month period. The PSQI is used to assess the impact of cognitive behavioral therapy for insomnia (CBT-I) on these sleep components. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Epworth Sleepiness Scale (ESS)
时间窗: Baseline (Day 1)
The Epworth Sleepiness Scale (ESS) is a sleep questionnaire consisting of 8 items that assesses daytime sleepiness. A score of 10 or higher indicates pathological daytime sleepiness. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Canadian Occupation Performance Measure (COPM)
时间窗: Baseline (day 1)
The Canadian Occupation Performance Measure (COPM) is a self-reported measure of an individual's perceived performance and satisfaction in important daily activities. Scores range from 1 (low) to 10 (high) for both performance and satisfaction, with higher scores indicating better outcomes.
Activity Card Sort (ACS)
时间窗: Baseline (day 1)
Occupational therapists use the Activity Card Sort (ACS) to help clients describe their social, instrumental, and leisure activities. For this study, we are going to use Electronic Activity Card Sort. It serves the same purpose as the paper/card version but is administered electronically. Total scores are expressed as a percentage (0-100%), with higher scores indicating greater participation and activity engagement.
Feasibility of Intervention Measure (FIM)
时间窗: Post intervention (final study visit)
Feasibility of Intervention Measure (FIM) is a questionnaire that includes 12 items for evaluating acceptability, feasibility, and appropriateness of the Intervention.
Client Satisfaction Questionnaire (CSQ-8)
时间窗: Post intervention (final study visit)
The Client Satisfaction Questionnaire (CSQ-8) was used to evaluate participant satisfaction with the intervention. Scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
Insomnia Severity Index (ISI)
时间窗: Post intervention (final study visit)
The Insomnia Severity Index (ISI) is a seven-item questionnaire developed to assess the severity of insomnia symptoms. Scores range from 0 to 28, with higher scores indicating more severe symptoms.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Post intervention (final study visit)
The Pittsburgh Sleep Quality Index (PSQI) is a sleep questionnaire that evaluates seven primary components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over a one-month period. The PSQI is used to assess the impact of cognitive behavioral therapy for insomnia (CBT-I) on these sleep components. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Epworth Sleepiness Scale (ESS)
时间窗: Post intervention (final study visit)
The Epworth Sleepiness Scale (ESS) is a sleep questionnaire consisting of 8 items that assesses daytime sleepiness. A score of 10 or higher indicates pathological daytime sleepiness. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Canadian Occupation Performance Measure (COPM)
时间窗: Post intervention (final study visit)
The Canadian Occupation Performance Measure (COPM) is a self-reported measure of an individual's perceived performance and satisfaction in important daily activities. Scores range from 1 (low) to 10 (high) for both performance and satisfaction, with higher scores indicating better outcomes.
Activity Card Sort (ACS)
时间窗: Post intervention (final study visit)
Occupational therapists use the Activity Card Sort (ACS) to help clients describe their social, instrumental, and leisure activities. For this study, we are going to use Electronic Activity Card Sort. It serves the same purpose as the paper/card version but is administered electronically. Total scores are expressed as a percentage (0-100%), with higher scores indicating greater participation and activity engagement.
次要结局
- Dysexecutive Questionnaire (DEX)(Baseline (day 1))
- Neurobehavioral Symptom Inventory (NSI)(Baseline (day 1))
- Fatigue Severity Scale (FSS)(Baseline (day 1))
- Beck's Depression Inventory (BDI)(Baseline (day 1))
- Depression Anxiety Stress Scale (DASS)(Baseline (day 1))
- Quality of Life after Brain Injury (QOLIBRI)(Baseline (day 1))
- Dysexecutive Questionnaire (DEX)(Post intervention (final study visit))
- Neurobehavioral Symptom Inventory (NSI)(Post intervention (final study visit))
- Fatigue Severity Scale (FSS)(Post intervention (final study visit))
- Beck's Depression Inventory (BDI)(Post intervention (final study visit))
- Depression Anxiety Stress Scale (DASS)(Post intervention (final study visit))
- Quality of Life after Brain Injury (QOLIBRI)(Post intervention (final study visit))
研究者
Sepideh Zenoozi
PhD candidate
University of Missouri-Columbia