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NCT Number: NCT04632628

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

Location status: Recruiting

Location contact

Christina McCrae

CONTACT

Riley Stephens

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 outcomes

  1. Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency

    Time frame: 6 weeks

    Subjective sleep onset latency (time to fall asleep)

  2. Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset

    Time frame: 6 weeks

    Subjective time awake after sleep onset

  3. Daily Electronic Sleep and Pain Diaries - Total Sleep Time

    Time frame: 6 weeks

    Subjective total sleep time

  4. Daily Electronic Sleep and Pain Diaries - Sleep Efficiency

    Time frame: 6 weeks

    Subjective sleep efficiency

  5. Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness

    Time frame: 6 weeks

    Pain Intensity & Unpleasantness

  6. Daily Electronic Sleep and Pain Diaries - Medication Consumption

    Time frame: 6 weeks

    Sleep and pain medication consumption

  7. Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency

    Time frame: 6 weeks

    Objective sleep onset latency (time to fall asleep)

  8. Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset

    Time frame: 6 weeks

    Objective time awake after sleep onset

  9. Objective Daily Sleep Actiwatch-2 - Total Sleep Time

    Time frame: 6 weeks

    Objective total sleep time

  10. Objective Daily Sleep Actiwatch-2 - Sleep Efficiency

    Time frame: 6 weeks

    Objective sleep efficiency

  11. Insomnia Severity Index

    Time frame: 6 weeks

    Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity

Secondary outcomes

  1. State Trait Anxiety Inventory (STAI-Y1)

    Time frame: 6 weeks

    Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety

  2. Beck Depression Inventory Second Edition (BDI- II)

    Time frame: 6 weeks

    Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression

  3. Perceived Stress Scale (PSS)

    Time frame: 6 weeks

    Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress

  4. Kingston Caregiver Stress Scale

    Time frame: 6 weeks

    Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress

  5. Dysfunctional Attitudes/Beliefs about Sleep (DBAS)

    Time frame: 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

  6. Caregiver Functional Unit Scale

    Time frame: 6 weeks

    Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability

  7. Online Cognitive Assessment - Stroop

    Time frame: 6 weeks

    Determine level of cognitive functioning

  8. Online Cognitive Assessment - Sternberg

    Time frame: 6 weeks

    Determine level of cognitive functioning

  9. Online Cognitive Assessment - Wisconsin Card Sorting Task

    Time frame: 6 weeks

    Determine level of cognitive functioning

  10. Cognitive Failures Questionnaire

    Time frame: 6 weeks

    Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure

  11. Dementia Patient's Caregiver Quality of Life Scale

    Time frame: 6 weeks

    Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life

  12. Zarit Burden Scale

    Time frame: 6 weeks

    Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden

Study contacts

Contact information is provided by the study sponsor or research team.

Christina S McCrae

CONTACT

[email protected]

573-882-0982

Riley Stephens

CONTACT

[email protected]

573-882-8881

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Acronym: NiteCAPP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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