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New treatment option for Insomnia Chronic
Official title Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
ClinicalTrials.gov ID: NCT04632628
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- CAREGIVER
- 18+ yrs
- Dementia caregiver living with person with dementia
- willing to be assigned by chance, 4. read/understand English
- insomnia diagnosis
You likely can't join if
- 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
See the full eligibility criteria
- CAREGIVER
- 18+ yrs
- Dementia caregiver living with person with dementia
- willing to be assigned by chance, 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.
- 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 assigned by chance Exclusion Criteria:
- Person with dementia or legally authorized representative is unable to consent
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.