Purpose

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

for the PLwCI: - Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or - Montreal Cognitive Assessment (MOCA) score between 12 and 24; - Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale; - Have an eligible caregiver; - Be able to participate in the intervention sessions Inclusion Criteria for Caregivers: - ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI); - Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or - ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months; - Have difficulty falling asleep or difficulty staying asleep for the last three months or - Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater

Exclusion Criteria

  • PLwCI: Moderate to severe cognitive impairment - Individuals who are not yet adults - Pregnant women - Prisoners - Individuals who are not able to clearly understand English.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cognitive Behavioral Therapy for Insomnia (CBTi)
Participant dyads will receive CBTi via videoconferencing sessions
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
    The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.
    Other names:
    • CBTi

Recruiting Locations

Emory Healthcare System
Atlanta 4180439, Georgia 4197000 30322
Contact:
Rashidat Ayantunji
404-727-9953
rayantu@emory.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Glenna S Brewster, PhD, RN, FNP
(404) 712-9164
glenna.brewster@emory.edu

Detailed Description

Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.