University of Missouri
Columbia, Missouri, 65212, United States
Location status: Recruiting
Location contact
Christina McCrae
CONTACT
Riley Stephens
CONTACT
NCT Number: NCT04632628
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbia, Missouri, 65212, United States
Location status: Recruiting
Christina McCrae
CONTACT
Riley Stephens
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
CAREGIVER
Inclusion criteria
Insomnia:
Exclusion criteria
PERSONS WITH DEMENTIA
Inclusion criteria
Exclusion criteria
Participants 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
Time frame: 6 weeks
Subjective sleep onset latency (time to fall asleep)
Time frame: 6 weeks
Subjective time awake after sleep onset
Time frame: 6 weeks
Subjective total sleep time
Time frame: 6 weeks
Subjective sleep efficiency
Time frame: 6 weeks
Pain Intensity & Unpleasantness
Time frame: 6 weeks
Sleep and pain medication consumption
Time frame: 6 weeks
Objective sleep onset latency (time to fall asleep)
Time frame: 6 weeks
Objective time awake after sleep onset
Time frame: 6 weeks
Objective total sleep time
Time frame: 6 weeks
Objective sleep efficiency
Time frame: 6 weeks
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Time frame: 6 weeks
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Time frame: 6 weeks
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Time frame: 6 weeks
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Time frame: 6 weeks
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Time frame: 6 weeks
evaluates sleep-related beliefs, expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues - higher scores indicates more dysfunctional beliefs and attitudes
Time frame: 6 weeks
Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Time frame: 6 weeks
Determine level of cognitive functioning
Time frame: 6 weeks
Determine level of cognitive functioning
Time frame: 6 weeks
Determine level of cognitive functioning
Time frame: 6 weeks
Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
Time frame: 6 weeks
Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life
Time frame: 6 weeks
Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden
Contact information is provided by the study sponsor or research team.
Christina S McCrae
CONTACT
Riley Stephens
CONTACT
University of South Florida
Other
Acronym: NiteCAPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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