Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Study Overview
=================
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 To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. To examine the mechanistic variables, including arousal (heart rate variability, HRV).

Official Title
-----------------
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Conditions
-----------------
Insomnia Chronic, Dementia

Intervention / Treatment
-----------------
* Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia<br>This is a pilot trial with one treatment condition (CBT-I). | Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Dementia Caregiver, Behavioral Interventions, Online Behavioral Intervention, Insomnia, Dementia