An interventional study of Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) in Insomnia Chronic and Dementia, sponsored by University of South Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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
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CAREGIVER
Inclusion Criteria:
Insomnia:
Exclusion Criteria:
PERSONS WITH DEMENTIA
Inclusion Criteria:
Exclusion Criteria:
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
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
Time frame: 6 weeks
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Subjective time awake after sleep onset
Time frame: 6 weeks
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Subjective total sleep time
Time frame: 6 weeks
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Subjective sleep efficiency
Time frame: 6 weeks
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Pain Intensity \& Unpleasantness
Time frame: 6 weeks
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Sleep and pain medication consumption
Time frame: 6 weeks
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Objective sleep onset latency (time to fall asleep)
Time frame: 6 weeks
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Objective time awake after sleep onset
Time frame: 6 weeks
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Objective total sleep time
Time frame: 6 weeks
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Objective sleep efficiency
Time frame: 6 weeks
Insomnia Severity Index
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Time frame: 6 weeks
State Trait Anxiety Inventory (STAI-Y1)
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Time frame: 6 weeks
Beck Depression Inventory Second Edition (BDI- II)
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Time frame: 6 weeks
Perceived Stress Scale (PSS)
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Time frame: 6 weeks
Kingston Caregiver Stress Scale
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Time frame: 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
Time frame: 6 weeks
Caregiver Functional Unit Scale
Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Time frame: 6 weeks
Online Cognitive Assessment - Stroop
Determine level of cognitive functioning
Time frame: 6 weeks
Online Cognitive Assessment - Sternberg
Determine level of cognitive functioning
Time frame: 6 weeks
Online Cognitive Assessment - Wisconsin Card Sorting Task
Determine level of cognitive functioning
Time frame: 6 weeks
Cognitive Failures Questionnaire
Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
Time frame: 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
Time frame: 6 weeks
Zarit Burden Scale
Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden
Time frame: 6 weeks
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