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Search / Trial NCT04632628

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Launched by UNIVERSITY OF SOUTH FLORIDA · Nov 16, 2020

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Dementia Caregiver Sleep Behavioral Interventions Online Behavioral Intervention Insomnia Dementia

ClinConnect Summary

This clinical trial is studying a new online program called NiteCAPP, which uses Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for family caregivers of people with dementia. Many caregivers face challenges like trouble sleeping, which can lead to feelings of depression and anxiety, affecting their overall health and quality of life. The goal of this study is to see how well NiteCAPP helps caregivers improve their sleep, mood, and daily functioning while also understanding their health needs.

To participate in the trial, caregivers must be at least 18 years old, live with someone who has dementia, and have a diagnosis of insomnia. They should not be using any sleep medications for at least six weeks before joining. Participants will receive four online sessions of therapy that they can schedule flexibly from home. This trial is currently recruiting, and those interested should be willing to take part in a random assignment to either the therapy group or a control group. This innovative approach aims to make effective sleep treatment more accessible for caregivers who often have limited time and resources.

Gender

ALL

Eligibility criteria

  • 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

About University Of South Florida

The University of South Florida (USF) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong commitment to improving patient outcomes, USF leverages its diverse faculty expertise and state-of-the-art facilities to conduct rigorous and ethically sound research. The university fosters collaboration across disciplines, engaging in partnerships that enhance the translation of scientific discoveries into effective therapeutic interventions. USF's clinical trial programs are designed to address pressing health challenges and contribute to the body of knowledge in various medical fields, ultimately aiming to benefit communities and improve public health.

Locations

Columbia, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Christina McCrae

Principal Investigator

University of Missouri-Columbia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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