Sleep DisturbanceNCT07826663
Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
A study testing Telephone-Coached Sleep Bibliotherapy and Educational Booklet in people with Sleep Disturbance and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Dementia
- What is being tested?
- Telephone-Coached Sleep Bibliotherapy and Educational Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: a) aged 18 years or older; b) provide unpaid care to a family member with dementia; c) living with the patient or actively involved in the patient's care daily for a minimum of 4 hours/day for at least 6 months; d) endorse one or more sleep problems; e) having the sleep problem with an average of 3 or more nights per week during the past month; d) taking no medication for sleep or stabilized on current medication for at least 6 weeks; e) could be contacted by phone.
Exclusion criteria: a) report a prior diagnosis of primary sleep disorder (e.g., sleep apnoea); b) have a severe chronic illness that could cause their sleep problems (e.g., emphysema); c) receive medical, psychological, or psychiatric treatment for sleep disturbance or depression; d) have cognitive impairment; e) be included in another interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mingyue HU, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Shanshan Wang, 68421201, shan-shan.wang@polyu.edu.hk
About this study
Official title: Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
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.
Read the detailed description
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of telephone-coached sleep bibliotherapy for informal caregivers of people with dementia.
A total of 120 eligible caregivers will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive an 8-week telephone-coached sleep bibliotherapy program.
The control group will receive an educational booklet containing general health information and weekly check-in calls. Both groups will continue receiving usual community services.
Data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include caregiving appraisal, dysfunctional beliefs and attitudes about sleep, emotional distress, neuropsyatric symptoms of care recipients, and quality of life.
The findings will provide evidence regarding the effectiveness of a low-cost and easily disseminated intervention for improving sleep and well-being among caregivers of people with dementia.
- Conditions
- Sleep Disturbance, Dementia
- Being tested
- Telephone-Coached Sleep Bibliotherapy, Educational Booklet
- Keywords
- Dementia Caregiver, Sleep Bibliotherapy, Sleep Quality, Caregiver, Insomnia, Telephone Coaching, Behavioral Intervention
- Medical subject headings
- Parasomnias, Dementia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Coached Sleep BibliotherapyBehavioural
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.
Educational BookletBehavioural
Participants receive an educational booklet containing general health information and weekly check-in telephone calls.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Measured: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826663
- Sponsor's protocol ID
- P0057423
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34002406
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07826663
- Acronym / sponsor ID
- P0057423
- Conditions
- Sleep Disturbance, Dementia
- Keywords
- Dementia Caregiver, Sleep Bibliotherapy, Sleep Quality, Caregiver, Insomnia, Telephone Coaching, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of telephone-coached sleep bibliotherapy for informal caregivers of people with dementia.
A total of 120 eligible caregivers will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive an 8-week telephone-coached sleep bibliotherapy program.
The control group will receive an educational booklet containing general health information and weekly check-in calls. Both groups will continue receiving usual community services.
Data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include caregiving appraisal, dysfunctional beliefs and attitudes about sleep, emotional distress, neuropsyatric symptoms of care recipients, and quality of life.
The findings will provide evidence regarding the effectiveness of a low-cost and easily disseminated intervention for improving sleep and well-being among caregivers of people with dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-Coached Sleep Bibliotherapy | Experimental | Behavioral: Telephone-Coached Sleep BibliotherapyParticipants 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. |
| Educational Booklet | Active comparator | Behavioral: Educational BookletParticipants receive an educational booklet containing general health information and weekly check-in telephone calls. The booklet does not include therapeutic sleep intervention components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-Coached Sleep BibliotherapyAn 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. | Behavioural | Telephone-Coached Sleep Bibliotherapy |
| Educational BookletParticipants receive an educational booklet containing general health information and weekly check-in telephone calls. | Behavioural | Educational Booklet |
Primary outcome
Sleep Quality
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 34002406Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingyue HU, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Coached Sleep Bibliotherapy and Educational Booklet in people with Sleep Disturbance and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan WANG, PhD (+852 2766 4696, shan-shan.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07826663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.