RECRUITING

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Quick Facts

Study Start:2022-01-02
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04632628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ yrs
  2. * Dementia caregiver living with person with dementia
  3. * willing to be randomized, 4. read/understand English
  4. * insomnia diagnosis
  5. * no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
  6. * complaints for 6+ mos
  7. * adequate opportunity and circumstances for sleep
  8. * 1+ of the following: difficulty falling asleep, staying asleep, or waking too early
  9. * daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
  10. * Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10
  11. * baseline diaries indicate \>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
  1. * unable to consent
  2. * cognitive impairment \[Telephone Interview for Cognitive Status (TICS) \<25 or Mini Mental State Examination (MMSE) \<26\]
  3. * sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15)\]
  4. * bipolar or seizure disorder
  5. * other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
  6. * severe untreated psychiatric comorbidity
  7. * psychotropic or other medications (e.g., beta-blockers) that alter sleep
  8. * non-pharmacological tx for sleep or mood outside current trial.

Contacts and Locations

Study Contact

Christina S McCrae
CONTACT
573-882-0982
mccraec@health.missouri.edu
Riley Stephens
CONTACT
573-882-8881
rstephens@health.missouri.edu

Principal Investigator

Christina McCrae
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Christina McCrae, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-02
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2022-01-02
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Insomnia Chronic
  • Dementia