Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
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- STATUS
- Recruiting
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- participants needed
- 80
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- sponsor
- Emory University
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:
- Assess the feasibility of a face-to-face or video conferencing dyad-based CBTi intervention.
- Evaluate the acceptability of a face-to-face or video conferencing dyad-based CBTi intervention.
- 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 |
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Age | 18years - 100years |
Treatment | Face-to-Face CBTi, Videoconferencing CBTi |
Clinical Study Identifier | NCT04426838 |
Sponsor | Emory University |
Last Modified on | 16 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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 moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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