Clinical trial NCT04426838: Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
Official title: Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Dementia
Keywords: Cognitive behavioral therapy for insomnia
Insomnia
Caregiver
Cognitive impairment
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2020-06-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.
Primary purpose: SUPPORTIVE_CARE

Brief 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 receive CBTi via 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.

Detailed 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 the researchers of this study seek to do with early-stage individuals and their caregivers. The researchers 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 via videoconferencing sessions who will receive the intervention as a unit. 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 video conferencing dyad-based CBTi intervention.
2. Evaluate the acceptability of a video conferencing dyad-based CBTi intervention.
3. Examine the preliminary efficacy of video conferencing CBTi intervention on sleep quality outcomes including sleep efficiency and perceived sleep quality.

Eligibility criteria: Inclusion Criteria for the PLwD

* Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and related dementias (ADRD)
* Co-residence with the caregiver in the community
* Montreal Cognitive Assessment (MOCA) score between 12 and 25
* Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days
* Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)

Inclusion Criteria for the Caregiver

* Informal caregivers (family/friends) of co-residing PLwD
* Providing unpaid assistance, on average 20 hours weekly, for a person in the early stage of illness who is community-dwelling
* Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30 minutes more than 3 nights weekly

Inclusion Criteria for the Dyad

* Tolerate and agrees to wear wrist actigraph
* Be able to read, speak and understand English
* Have no uncorrectable vision or hearing deficits that might impede participation

Exclusion Criteria for the PLwD

* None

Exclusion Criteria for the Caregivers

* Moderate to severe cognitive impairment defined as 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 which would interfere with the subject's ability to realistically follow the study protocol

Primary outcomes:
measure: Change in Adherence with Study Interventions
timeFrame: Weeks 1, 2, 3, 4
measure: Percent Attrition from the Study
timeFrame: Week 4
measure: Acceptability the Intervention
timeFrame: Week 5 (1 week post-intervention)
Secondary outcomes:
measure: Change in Sleep Disorders Inventory (SDI) - Frequency Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in Sleep Disorders Inventory (SDI) - Severity Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in Insomnia Severity Index Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
measure: Change in Sleep Duration
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
measure: Change in Sleep Fragmentation Index
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
measure: Change in Sleep Onset Latency
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
measure: Change in Wake After Sleep Onset
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
measure: Change in Bed Time
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
measure: Change in Wake Time
timeFrame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Goizueta Alzheimer's Disease Research Center
state: Georgia
Study officials:
affiliation: Emory University
name: Glenna Brewster, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: