NCT07572565

Brief Summary

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:

  • Does REPAIR Sleep improve insomnia severity and other sleep outcomes?
  • Does REPAIR Sleep improve psychological outcomes such as mood, stress, and quality of life? Researchers will compare REPAIR Sleep with Healthy Living to see whether REPAIR Sleep leads to greater improvements. Participants will:
  • Attend five weekly virtual sessions
  • Complete sleep diaries and questionnaires
  • Wear an actigraphy device
  • Complete follow-up assessments over 9 months

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

April 27, 2026

Last Update Submit

May 1, 2026

Conditions

Cognition DisorderAlzheimer Disease

Keywords

Persons living with cognitive changesPersons living with Alzheimer's disease and related dementiasCognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Change in total sleep time (TST)

    Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

  • Change in sleep efficiency (SE)

    Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

  • Nocturnal awakenings

    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

    Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

  • Depressive symptoms

    Baseline - Day 1, 1-week post-intervention - Week 8 , 3-months post intervention - Week 20, 6-months post intervention- Week 32

  • +2 more secondary outcomes

Study Arms (2)

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: * Attend five weekly 60-minute virtual sessions with a trained interventionist * Review and complete sleep diaries and daily adherence checklists * Wear a wrist actigraph (CentrePoint Insight Watch) for 2 weeks before and during the 5-week intervention * Practice CBT-I components between sessions (e.g., stimulus control, sleep compression, relaxation, cognitive strategies, sleep hygiene)

Behavioral: REPAIR Sleep

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: * Attend five weekly 60-minute virtual sessions with a facilitator * Receive a manual and workbook with educational materials and exercises * Complete health-related journals (e.g., food intake, physical activity, sleep hygiene practices) * Wear a wrist actigraph and complete sleep diaries on the same schedule as the intervention arm

Behavioral: Healthy Living

Interventions

REPAIR SleepBEHAVIORAL

REPAIR Sleep is a dyadic CBT-I program delivered via videoconferencing over 5 weekly sessions (60 minutes each). Core components include: * Stimulus control: establishing consistent wake times and strengthening the bed-sleep association * Sleep compression: gradually adjusting time in bed to improve sleep efficiency, using a milder form appropriate for older adults and PLwD * Relaxation training: techniques to reduce physiological and cognitive arousal at bedtime; can be practiced individually or together * Cognitive therapy: identifying and modifying unhelpful thoughts and beliefs about sleep and its consequences * Sleep hygiene education: optimizing environmental and behavioral factors that influence sleep 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.

REPAIR Sleep
Healthy LivingBEHAVIORAL

Healthy Living is an attention-matched, 5-week behavioral health education program delivered via videoconferencing. Weekly 60-minute sessions cover: * Week 1: Healthy aging principles, components of a healthy lifestyle, nutrition basics, budgeting for nutritious meals, meal planning, and food journaling * Week 2: Sleep hygiene education, introduction to flexibility exercises and stretches, activity journaling, and goal setting * Week 3: Balance exercises, fall prevention strategies (including safe bed exits at night), and weight-bearing aerobic exercise * Week 4: Strength training using resistance bands and light weights * Week 5: Integration of exercise, nutrition, and sleep hygiene; review and goal setting for continued healthy living The program emphasizes goal setting, progress tracking, and behavioral reinforcement, with dyads encouraged to implement lifestyle changes and discuss successes and challenges during sessions.

Healthy Living

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PLwCC and Caregiver
  • Have Insomnia Severity Index (ISI) ≥10
  • Have difficulty initiating or maintaining sleep or waking up too early at least three nights per week
  • Have sleep disturbances persisting for at least three months
  • Have daytime impairment (e.g., fatigue, mood disturbance)
  • Community-dwelling
  • Co-residing with each other
  • Have internet access
  • No history of surgery in the past 4 weeks
  • 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.

You may not qualify if:

  • PLwCC or Caregiver:
  • A diagnosis of psychosis, major depressive disorder, or bipolar disorder that is not currently treated;
  • Having had substance or alcohol dependency, or active suicidality in the past year
  • Currently have narcolepsy or restless leg syndrome
  • Does shift work
  • Plan trans-meridian travel during the period of data collection blocks
  • Hearing or visual impairment
  • Caregivers
  • Dementia or cognitive impairment.
  • Individuals who are not yet adults
  • Pregnant women
  • Prisoners
  • Individuals who are not able to clearly understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognition DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Glenna Brewster, PhD, RN

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenna S Brewster, PhD, RN

CONTACT

(404) 712-9164glenna.brewster@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 7, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share