Recruiting

WebCBT-I

Sponsor:

University of South Florida

Code:

NCT04632628

Conditions

Insomnia Chronic

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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).

Conditions

Insomnia Chronic

Dementia

Study ID

NCT04632628

Start date

Nov 14, 2023

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia

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

Interventions

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

Primary outcome measure

  • Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency [ Time Frame: 6 weeks ]
  • Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset [ Time Frame: 6 weeks ]
  • Daily Electronic Sleep and Pain Diaries - Total Sleep Time [ Time Frame: 6 weeks ]
  • Daily Electronic Sleep and Pain Diaries - Sleep Efficiency [ Time Frame: 6 weeks ]
  • Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness [ Time Frame: 6 weeks ]
  • Daily Electronic Sleep and Pain Diaries - Medication Consumption [ Time Frame: 6 weeks ]
  • Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency [ Time Frame: 6 weeks ]
  • Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset [ Time Frame: 6 weeks ]
  • Objective Daily Sleep Actiwatch-2 - Total Sleep Time [ Time Frame: 6 weeks ]
  • Objective Daily Sleep Actiwatch-2 - Sleep Efficiency [ Time Frame: 6 weeks ]
  • Insomnia Severity Index [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Christina S McCrae

573-882-0982mccraec@health.missouri.edu

Riley Stephens

573-882-8881rstephens@health.missouri.edu

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

More Information

Sponsor

University of South Florida

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Dementia Caregiver
  • Sleep
  • Behavioral Interventions
  • Online Behavioral Intervention
  • Insomnia
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-06-15.