Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
NCT ID: NCT04632628
Last Updated: 2025-03-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-11-14
Study Completion Date
2027-03-31
Brief Summary
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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
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).
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).
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Detailed Description
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Conditions
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Insomnia Chronic
Dementia
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
This is a pilot trial with one treatment condition (CBT-I).
Group Type
EXPERIMENTAL
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
Intervention Type
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
Interventions
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Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
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
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 18+ yrs
* Dementia caregiver living with person with dementia
* willing to be randomized, 4. read/understand English
* insomnia diagnosis
* no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
Insomnia:
* 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.
* 18+ yrs
* Persons with dementia living with caregiver
* Have an eligible caregiver
* willing to be randomized
* Dementia caregiver living with person with dementia
* willing to be randomized, 4. read/understand English
* insomnia diagnosis
* no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
Insomnia:
* 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.
* 18+ yrs
* Persons with dementia living with caregiver
* Have an eligible caregiver
* willing to be randomized
Exclusion Criteria
* 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
• Person with dementia or legally authorized representative is 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
• Person with dementia or legally authorized representative is unable to consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of South Florida
OTHER
Sponsor Role
lead
Responsible Party
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Christina McCrae
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Christina McCrae
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri
Columbia, Missouri, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Christina McCrae
Role: primary
Riley Stephens
Role: backup
References
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DERIVED
Other Identifiers
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2017125
Identifier Type: -
Identifier Source: org_study_id
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