About this trial
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
1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. 2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18+ yrs
Dementia caregiver living with person with dementia
willing to be randomized, 4. read/understand English
insomnia diagnosis
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
BehavioralParticipants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change
Treatment groups
Trial outcomes
Primary outcomes
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Subjective time awake after sleep onset
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Subjective total sleep time
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Subjective sleep efficiency
Secondary outcomes
State Trait Anxiety Inventory (STAI-Y1)
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Beck Depression Inventory Second Edition (BDI- II)
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Perceived Stress Scale (PSS)
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Kingston Caregiver Stress Scale
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Sponsors and contacts
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