Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Emory University
Updated on 16 February 2024
cognitive therapy
psychotropic drugs
alzheimer's disease
sleep disorder
dementia
actigraphy
hearing impairment
behavior modification

Summary

Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase 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 researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will be randomized to face-to face or videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.

Description

Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience sleep disturbances, which are distressing for both the PLwD and their caregivers. Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a myriad of psychological, cognitive, behavioral, and physiological health issues and poor quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and the negative health consequences of sleep disturbances on the dyad, there is a critical need to develop and provide effective interventions to improve their sleep. Pharmacologic treatment often results in potential harmful side effects like falls and cognitive decline; therefore, non-pharmacologic approaches are recommended for this population.

Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has demonstrated effectiveness for improving sleep disturbances in multiple populations, is delivered in various formats including face-to-face and videoconferencing. Individually, PLwD and caregivers have successfully deployed behavioral sleep techniques, resulting in improved sleep quality. However, there is no current published research on CBTi completed simultaneously by the PLwD-caregiver dyad, and that is exactly what we seek to do with early-stage individuals and their caregivers. We premise this effort on the notion that a dyadic intervention can use early-stage individuals' retained capacity for communication and comprehension to establish in-the-moment agreements about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in the PLwD and to pair that with acquired strategies to engender his/her own positive sleep behaviors.

This project seeks to gather formative and preliminary data on CBTi delivered simultaneously to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi intervention administered to 40 PLwD-caregiver dyads randomized to face-to face or videoconferencing sessions who will receive the intervention as a unit. Participants will be recruited through the Alzheimer's Association and the Goizueta Alzheimer's Disease Research Center at Emory University. Objective and subjective sleep, depressive symptoms, and cognitive health data will be collected at baseline, and 1 week and 3 months post-completion of the intervention.

In community-dwelling PLwD and their caregivers where both persons in the dyad self-report sleep disturbances, the specific aims for this study are:

  1. Assess the feasibility of a face-to-face or video conferencing dyad-based CBTi intervention.
  2. Evaluate the acceptability of a face-to-face or video conferencing dyad-based CBTi intervention.
  3. Examine the preliminary efficacy of face-to-face or video conferencing CBTi intervention on sleep quality outcomes including sleep efficiency and perceived sleep quality.

Details
Condition Dementia, Dementia, Alzheimer's Disease, Alzheimer's Disease
Age 18years - 100years
Treatment Face-to-Face CBTi, Videoconferencing CBTi
Clinical Study IdentifierNCT04426838
SponsorEmory University
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

b"Physician diagnosis of mild Alzheimer's disease and related dementias (ADRD) using"
b'tandard assessments and diagnostic criteria or Clinical Dementia Rating (CDR) of 1'
b'Community-dwelling with no plan of moving into an assisted living or nursing home'
b'community in the next six months'
b'Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or'
b'opioids in the past 90 days'
b'Informal caregivers (family/friends) of PLWD'
b'Providing at least 4 hours per day unpaid assistance, on average, for a person in the'
b'early stage of illness who is community-dwelling and for whom there is no established'
b'plan for moving into an assisted living or nursing home community in the next six'
b'months'
b'Tolerate and agrees to wear wrist actigraph'
b'Presence of sleep problems determined first using the Neuropsychiatric Inventory sleep'
b'disorders item then the proxy-rated Sleep Disorders Inventory (presence of at least'
b'one sleep disturbance symptom of moderate severity'
b'Be able to read, speak and understand English'
b'Have no uncorrectable vision or hearing deficits that might impede participation'

Exclusion Criteria

b'Planned transition to another residential or institutional care setting in less than 6'
b'months'
b'Moderate to severe cognitive impairment defined as MoCA score <17'
b'Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule'
b'within the prior three months'
b'Presence of an acute medical or psychiatric condition which would interfere with the'
b"ubject's ability to realistically follow the study protocol"
Clear my responses

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.