Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Daily Electronic Sleep and Pain Diaries - Total Sleep Time
研究概览
简要总结
Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.
Objectives
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.
- To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Dementia caregiver living with person with dementia
- •willing to be randomized,
- •read/understand English
- •insomnia diagnosis
- •no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
- •complaints for 6+ mos
- •adequate opportunity and circumstances for sleep
- •1+ of the following: difficulty falling asleep, staying asleep, or waking too early
- •daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
- •Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10
- •baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
排除标准
- •unable to consent
- •cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25 or Mini Mental State Examination (MMSE) <26]
- •sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)]
- •bipolar or seizure disorder
- •other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
- •severe untreated psychiatric comorbidity
- •psychotropic or other medications (e.g., beta-blockers) that alter sleep
- •non-pharmacological tx for sleep or mood outside current trial.
- •PERSONS WITH DEMENTIA
- •Inclusion Criteria:
- •Persons with dementia living with caregiver
- •Have an eligible caregiver
- •willing to be randomized
- •Exclusion Criteria:
- •Person with dementia or legally authorized representative is unable to consent
研究组 & 干预措施
NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
This is a pilot trial with one treatment condition (CBT-I).
干预措施: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) (Behavioral)
结局指标
主要结局
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
时间窗: 6 weeks
Subjective total sleep time
Daily Electronic Sleep and Pain Diaries - Medication Consumption
时间窗: 6 weeks
Sleep and pain medication consumption
Insomnia Severity Index
时间窗: 6 weeks
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
时间窗: 6 weeks
Subjective sleep onset latency (time to fall asleep)
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
时间窗: 6 weeks
Pain Intensity \& Unpleasantness
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
时间窗: 6 weeks
Objective sleep onset latency (time to fall asleep)
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
时间窗: 6 weeks
Objective time awake after sleep onset
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
时间窗: 6 weeks
Objective sleep efficiency
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
时间窗: 6 weeks
Objective total sleep time
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
时间窗: 6 weeks
Subjective time awake after sleep onset
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
时间窗: 6 weeks
Subjective sleep efficiency
次要结局
- Caregiver Functional Unit Scale(6 weeks)
- Dysfunctional Attitudes/Beliefs about Sleep (DBAS)(6 weeks)
- State Trait Anxiety Inventory (STAI-Y1)(6 weeks)
- Beck Depression Inventory Second Edition (BDI- II)(6 weeks)
- Perceived Stress Scale (PSS)(6 weeks)
- Online Cognitive Assessment - Stroop(6 weeks)
- Zarit Burden Scale(6 weeks)
- Kingston Caregiver Stress Scale(6 weeks)
- Online Cognitive Assessment - Wisconsin Card Sorting Task(6 weeks)
- Online Cognitive Assessment - Sternberg(6 weeks)
- Cognitive Failures Questionnaire(6 weeks)
- Dementia Patient's Caregiver Quality of Life Scale(6 weeks)
研究者
Christina McCrae
Professor
University of South Florida