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Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

RecruitingNAAges 18 Years - anyAllUniversity of South Florida
NCT04632628 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 insom

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
University of Missouri
Columbia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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