NCT07826663

Brief Summary

Sleep disturbances are common among informal caregivers of people with dementia and can negatively affect their physical and psychological well-being. This randomized controlled trial aims to evaluate the effectiveness of an 8-week telephone-coached sleep bibliotherapy program in improving sleep quality among informal caregivers of people with dementia. Participants will be randomly assigned to either a sleep bibliotherapy intervention group or an educational booklet control group. Outcomes including sleep quality, caregiving appraisal, dysfunctional beliefs about sleep, emotional distress, neuropsychiatric symptoms of care recipients, and quality of life will be assessed at baseline, immediately post-intervention, and 3 months post-intervention.

Trial Health

77
On Track

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
26mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress8%
Aug 2026Dec 2028

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 17, 2026

Status Verified

August 1, 2026

Enrollment Period

2.3 years

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

DementiaSleep Disturbance

Keywords

Dementia CaregiverSleep BibliotherapySleep QualityCaregiverInsomniaTelephone CoachingBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.

    Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention

Other Outcomes (5)

  • Caregiving Appraisal

    Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention

  • Dysfunctional beliefs and attitudes about sleep

    Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention

  • Emotional distress

    Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention

  • +2 more other outcomes

Study Arms (2)

Telephone-Coached Sleep Bibliotherapy

EXPERIMENTAL

Participants receive an 8-week sleep bibliotherapy program consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching. The intervention integrates dementia caregiving education with behavioral and cognitive strategies for improving sleep.

Behavioral: Telephone-Coached Sleep Bibliotherapy

Educational Booklet

ACTIVE COMPARATOR

Participants receive an educational booklet containing general health information and weekly check-in telephone calls. The booklet does not include therapeutic sleep intervention components.

Behavioral: Educational Booklet

Interventions

Telephone-Coached Sleep BibliotherapyBEHAVIORAL

An 8-week behavioral intervention consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching. The intervention integrates dementia caregiving education with behavioral and cognitive strategies to improve sleep among informal caregivers of people with dementia.

Telephone-Coached Sleep Bibliotherapy
Educational BookletBEHAVIORAL

Participants receive an educational booklet containing general health information and weekly check-in telephone calls.

Educational Booklet

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

Related Publications (1)

  • Wang S, Cheung DSK, Leung AYM, Davidson PM. Bibliotherapy for improving caregiving appraisal of informal caregivers of people with dementia: A pilot randomized controlled trial. Res Nurs Health. 2021 Aug;44(4):692-703. doi: 10.1002/nur.22143. Epub 2021 May 18.

    PMID: 34002406BACKGROUND

MeSH Terms

Conditions

ParasomniasDementiaSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersSleep Disorders, IntrinsicDyssomnias

Central Study Contacts

Shanshan WANG, PhD

CONTACT

+852 2766 4696shan-shan.wang@polyu.edu.hk

Mingyue HU, PhD

CONTACT

+852 54131253

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group allocation throughout the study. Participants and intervention providers cannot be blinded due to the nature of the behavioral intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)