Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
- Conditions
- Insomnia ChronicDementia
- Interventions
- Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
- Registration Number
- NCT04632628
- Lead Sponsor
- University of South Florida
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) This is a pilot trial with one treatment condition (CBT-I).
- Primary Outcome Measures
Name Time Method Daily Electronic Sleep and Pain Diaries - Total Sleep Time 6 weeks Subjective total sleep time
Insomnia Severity Index 6 weeks Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Daily Electronic Sleep and Pain Diaries - Medication Consumption 6 weeks Sleep and pain medication consumption
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency 6 weeks Subjective sleep onset latency (time to fall asleep)
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness 6 weeks Pain Intensity \& Unpleasantness
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency 6 weeks Objective sleep onset latency (time to fall asleep)
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset 6 weeks Objective time awake after sleep onset
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency 6 weeks Objective sleep efficiency
Objective Daily Sleep Actiwatch-2 - Total Sleep Time 6 weeks Objective total sleep time
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset 6 weeks Subjective time awake after sleep onset
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency 6 weeks Subjective sleep efficiency
- Secondary Outcome Measures
Name Time Method Dysfunctional Attitudes/Beliefs about Sleep (DBAS) 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
State Trait Anxiety Inventory (STAI-Y1) 6 weeks Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Beck Depression Inventory Second Edition (BDI- II) 6 weeks Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Perceived Stress Scale (PSS) 6 weeks Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Online Cognitive Assessment - Stroop 6 weeks Determine level of cognitive functioning
Zarit Burden Scale 6 weeks Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden
Kingston Caregiver Stress Scale 6 weeks Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Caregiver Functional Unit Scale 6 weeks Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Online Cognitive Assessment - Wisconsin Card Sorting Task 6 weeks Determine level of cognitive functioning
Online Cognitive Assessment - Sternberg 6 weeks Determine level of cognitive functioning
Cognitive Failures Questionnaire 6 weeks Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
Dementia Patient's Caregiver Quality of Life Scale 6 weeks Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life
Trial Locations
- Locations (1)
University of Missouri
🇺🇸Columbia, Missouri, United States