Online cognitive behavioral therapy for insomnia in dementia caregivers

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

This study tests if an online therapy program can help caregivers of people with dementia sleep better and improve their mood.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of South Florida (other)
• Locations: 1 site (Columbia, Missouri)
• Trial ID: NCT04632628 on ClinicalTrials.gov

What this trial studies

This study focuses on providing a web-based cognitive behavioral therapy for insomnia (CBT-I) specifically designed for caregivers of individuals with dementia. It aims to address the high prevalence of insomnia among these caregivers, which can lead to negative health outcomes such as depression and anxiety. The intervention consists of a brief, four-session protocol that has been adapted for the unique challenges faced by dementia caregivers. The effectiveness of this online approach will be evaluated by measuring changes in insomnia symptoms and overall mood.

Who should consider this trial

Good fit: Ideal candidates for this study are caregivers aged 18 and older who are living with a person diagnosed with dementia and experiencing insomnia.

Not a fit: Patients who are unable to consent, have cognitive impairments, or suffer from sleep disorders other than insomnia may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and mental health for caregivers of dementia patients.

How similar studies have performed: Previous studies have shown that cognitive behavioral therapy for insomnia is effective in various populations, suggesting potential success for this adapted approach in dementia caregivers.

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

Where this trial is running

Columbia, Missouri

• University of Missouri — Columbia, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Christina McCrae — University of Missouri-Columbia
• Study coordinator: Christina S McCrae

Conditions: Insomnia Chronic, Dementia, Dementia Caregiver, Sleep, Behavioral Interventions, Online Behavioral Intervention, Insomnia