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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia | Experimental | This is a pilot trial with one treatment condition (CBT-I). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency | Subjective sleep onset latency (time to fall asleep) | 6 weeks |
| Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset | Subjective time awake after sleep onset | 6 weeks |
| Daily Electronic Sleep and Pain Diaries - Total Sleep Time | Subjective total sleep time | 6 weeks |
| Daily Electronic Sleep and Pain Diaries - Sleep Efficiency | Subjective sleep efficiency | 6 weeks |
| Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness | Pain Intensity & Unpleasantness | 6 weeks |
| Daily Electronic Sleep and Pain Diaries - Medication Consumption | Sleep and pain medication consumption | 6 weeks |
| Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency | Objective sleep onset latency (time to fall asleep) | 6 weeks |
| Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset | Objective time awake after sleep onset |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory (STAI-Y1) | Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety | 6 weeks |
| Beck Depression Inventory Second Edition (BDI- II) | Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression |
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CAREGIVER
Inclusion Criteria:
Insomnia:
Exclusion Criteria:
PERSONS WITH DEMENTIA
Inclusion Criteria:
Exclusion Criteria:
• Person with dementia or legally authorized representative is unable to consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina S McCrae | Contact | 573-882-0982 | mccraec@health.missouri.edu | |
| Riley Stephens | Contact | 573-882-8881 | rstephens@health.missouri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina McCrae | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18763429 | Background | Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9. | |
| 21320949 | Background | Fonareva I, Amen AM, Zajdel DP, Ellingson RM, Oken BS. Assessing sleep architecture in dementia caregivers at home using an ambulatory polysomnographic system. J Geriatr Psychiatry Neurol. 2011 Mar;24(1):50-9. doi: 10.1177/0891988710397548. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| 6 weeks |
| Objective Daily Sleep Actiwatch-2 - Total Sleep Time | Objective total sleep time | 6 weeks |
| Objective Daily Sleep Actiwatch-2 - Sleep Efficiency | Objective sleep efficiency | 6 weeks |
| Insomnia Severity Index | Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity | 6 weeks |
| 6 weeks |
| Perceived Stress Scale (PSS) | Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress | 6 weeks |
| Kingston Caregiver Stress Scale | Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress | 6 weeks |
| Dysfunctional Attitudes/Beliefs about Sleep (DBAS) | 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 | 6 weeks |
| Caregiver Functional Unit Scale | Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability | 6 weeks |
| Online Cognitive Assessment - Stroop | Determine level of cognitive functioning | 6 weeks |
| Online Cognitive Assessment - Sternberg | Determine level of cognitive functioning | 6 weeks |
| Online Cognitive Assessment - Wisconsin Card Sorting Task | Determine level of cognitive functioning | 6 weeks |
| Cognitive Failures Questionnaire | Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure | 6 weeks |
| Dementia Patient's Caregiver Quality of Life Scale | Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life | 6 weeks |
| Zarit Burden Scale | Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden | 6 weeks |
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| D001523 |
| Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |