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Insomnia Therapy for People Living With Dementia and Their Caregivers

Recruiting

This study will test cognitive behavioral therapy (a form of talk therapy) for insomnia to improve the sleep of persons living with dementia and their caregivers who are both experiencing sleep problems. The intervention is designed to target both the caregiver and the person with dementia simultaneously to improve sleep outcomes.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years N/A All Yes
June 2020
August 2022
80

Persons Living with Dementia (PLWD) Participants:

  • Physician diagnosis of mild Alzheimer's disease and/or related dementias (ADRD) using standard assessments and diagnostic criteria or Clinical Dementia Rating (CDR) of 1
  • Community-dwelling with no plan of moving into an assisted living or nursing home community in the next six months
  • Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days

Caregiver Participants:

  • Informal caregiver, for example, a family member or friend of the PLWD
  • Providing at least four hours per day unpaid assistance, on average, for the PLWD participant

Both Participants (Caregiver and PLWD):

  • Tolerate and agree to wear wrist actigraph
  • Presence of sleep problems determined first using the Neuropsychiatric Inventory sleep disorders item then the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)
  • Be able to read, speak, and understand English
  • No vision or hearing problems that would affect study participation 

Exclusion Criteria for the PLWD:

  • Planned transition to another residential or institutional care setting in less than six months

Exclusion Criteria for the Caregivers:

  • Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MoCA) score <17
  • Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
  • Presence of an acute medical or psychiatric condition that would interfere with following the study protocol

Disturbed sleep is stressful to persons living with dementia (PLWD) and their caregivers. Given the potential harmful side effects of medications, a non-medication alternative like cognitive behavioral therapy for insomnia may be safer to improve disturbed sleep in this population.

Cognitive behavioral therapy for insomnia (CBTi) has been effective in improving sleep outcomes for individuals over the long-term. Because disturbed sleep in the PLWD-caregiver pair is interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both individuals.

For the  four-week CBTi intervention each PLWD-caregiver pair will be randomly assigned to either face-to-face or video conferencing sessions. Sleep data, depressive symptoms, and cognitive health data will be collected at the start of the study, and at 1 week and 3 months after completion of the intervention.

Name City State Zip Status Primary Contact
Emory University
Atlanta Georgia 30322 Recruiting

Goizueta Alzheimer's Disease Research Center
Atlanta Georgia 30329 Recruiting

Emory University

  • Alzheimer's Association

Name Role Affiliation
Glenna Brewster, PhD, RN Principal Investigator Emory University

Name Phone Email
Glenna Brewster, PhD, RN 404-712-9164 glenna.brewster@emory.edu

NCT04426838

Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad