Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG093890-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to learn whether a videoconference-delivered CBT-I program (REPAIR Sleep) can improve sleep and psychological well-being in caregiver-PLwD dyads. The main questions it aims to answer are:
Participants will:
Sleep disturbance is highly prevalent among persons living with Alzheimer's disease and related dementias (PLwD) and their caregivers. PLwD commonly experience fragmented sleep, increased wake after sleep onset, and frequent nighttime awakenings, which often require caregiver supervision. As a result, caregivers often experience poor sleep quality, shorter sleep duration, and symptoms of insomnia. Sleep disturbance in both members of the dyad is associated with poorer psychological health, reduced quality of life, and earlier residential placement of PLwD.
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line, evidence-based treatment for insomnia and has demonstrated effectiveness across diverse populations, including when delivered via videoconferencing. CBT-I targets behavioral and cognitive factors that perpetuate insomnia, using strategies such as stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. Prior research suggests that caregiver involvement can enhance the implementation of behavioral sleep strategies for PLwD and may improve outcomes for both members of the dyad.
This study will test REPAIR Sleep, a 5-week CBT-I intervention delivered virtually to caregiver-PLwD dyads. The intervention incorporates behavioral sleep strategies, cognitive techniques, and collaborative problem-solving. Written and recorded agreements and daily logs are used to support memory challenges in PLwD and promote consistent practice of sleep-related behaviors. Dyads randomized to the comparison group will receive Healthy Living, an attention-matched program focused on general wellness topics unrelated to sleep.
The study will evaluate immediate and 6-month changes in insomnia severity, sleep efficiency, sleep onset latency, and wake after sleep onset, measured through validated questionnaires, sleep diaries, and actigraphy. Psychological outcomes-including affect, depressive symptoms, stress, and quality of life-will also be assessed. The study will further examine whether adherence to REPAIR Sleep components and interpersonal support within the dyad are associated with improvements in sleep and psychological outcomes. Participants will be followed for approximately 9 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPAIR Sleep | Experimental | Caregiver-PLwD dyads randomized to this arm will receive REPAIR Sleep, a 5-week, 60-minute, videoconference-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention. Sessions are delivered once weekly to both members of the dyad together. The intervention targets behavioral and cognitive factors that perpetuate insomnia and is tailored to the needs of caregivers and persons living with dementia. Participants will:
|
|
| Healthy Living | Active Comparator | Caregiver-PLwD dyads randomized to this arm will receive Healthy Living, a 5-week, 60-minute, videoconference-delivered attention control intervention adapted from the National Institute on Aging's Go4Life program. The content focuses on general health and wellness (e.g., nutrition, physical activity, fall prevention), with sleep hygiene included as one topic. Sleep-specific behavioral and cognitive strategies from CBT-I are not provided in this arm. Participants will:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REPAIR Sleep | Behavioral | REPAIR Sleep is a dyadic CBT-I program delivered via videoconferencing over 5 weekly sessions (60 minutes each). Core components include:
The intervention uses written and recorded agreements and daily logs to support memory challenges in PLwD and to promote consistent practice of sleep behaviors. Both dyad members attend all sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insomnia severity | Change in insomnia symptom severity, measured using the Insomnia Severity Index (ISI), a 7-item validated self-report scale assessing difficulty falling asleep, staying asleep, early awakenings, satisfaction with sleep, interference with daily functioning, noticeability of impairment, and distress caused by sleep problems. Scores range from 0-28, with higher scores indicating more severe insomnia symptoms. | Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep time (TST) | This will be reported as a change in total minutes scored as sleep per night. Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns. Higher TST indicates better sleep. | Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
Not provided
Inclusion Criteria:
PLwCC and Caregiver
Caregivers -Regularly assist the care recipient with ≥1 of 7 basic activities of daily living61 or ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months.
PLwD
-Reported or diagnosed cognitive impairment; able to complete simple directives.
Exclusion Criteria:
PLwCC or Caregiver:
Caregivers
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glenna S Brewster, PhD, RN | Contact | (404) 712-9164 | glenna.brewster@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Glenna Brewster, PhD, RN | Emory University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Healthy Living | Behavioral | Healthy Living is an attention-matched, 5-week behavioral health education program delivered via videoconferencing. Weekly 60-minute sessions cover:
|
|
| Change in sleep efficiency (SE) | This will be reported as a percentage of time in bed spent asleep Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns. Higher (SE) indicates better sleep. | Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Nocturnal awakenings | This will be reported as the count of awakenings per night. Data will be collected through actigraphy. Actigraphy provides continuous movement-based estimates of sleep-wake patterns. | Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Change in Quality of life | Change in quality of life measured using the World Health Organization Quality of Life - BREF (WHOQOL-BREF). This instrument assesses four domains:
Items are rated on a Likert scale and transformed to domain scores:
| Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Depressive symptoms | Change in depressive symptoms measured using the Center for Epidemiologic Studies Depression Scale (CES-D).
| Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Positive and Negative Affect | Change in affect measured using the Positive and Negative Affect Schedule (PANAS). The PANAS includes two 10-item subscales:
Each item is rated on a Likert scale (e.g., 1-5), and subscale scores are summed:
| Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| Percieved stress | Change in perceived stress measured using the Perceived Stress Scale (PSS). The PSS is a widely used self-report questionnaire assessing the degree to which situations in one's life are appraised as stressful over the past month.
| Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |