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

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).

Study Overview

• Status: Recruiting
• Conditions: Dementia; Insomnia Chronic
• Intervention / Treatment: Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina S McCrae; Phone Number: 573-882-0982; Email: mccraec@health.missouri.edu
• Study Contact Backup: Name: Riley Stephens; Phone Number: 573-882-8881; Email: rstephens@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri
      • Contact: Riley Stephens
      • Contact: Christina McCrae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia; This is a pilot trial with one treatment condition (CBT-I).	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity	6 weeks
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

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

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Christina McCrae, University of Missouri-Columbia

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Sleep; Dementia; Insomnia; Behavioral Interventions; Dementia Caregiver; Online Behavioral Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Sleep Initiation and Maintenance Disorders; Dementia
• Other Study ID Numbers: 2017125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No