Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers (NiteCAPP)

University of South Florida

Status: Enrolling

Conditions: Dementia; Insomnia Chronic

Treatments: Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT04632628

2017125

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

CAREGIVER

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.

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

Inclusion Criteria:

• 18+ yrs
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia

Experimental group

Description:

This is a pilot trial with one treatment condition (CBT-I).

Treatment:

Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)