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NCT Number: NCT07826663

Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location status: Recruiting

Location contact

Shanshan Wang

CONTACT

[email protected]

68421201

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone-Coached Sleep Bibliotherapy

Behavioral

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 booklet

Behavioral

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

Primary outcomes

  1. 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.

Other outcomes

  1. Caregiving Appraisal

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

    The Chinese version of the Caregiving Appraisal Scale will be used. This is a 5-point Likert scale with 26 items and four subscales (caregiving satisfaction, caregiving mastery, subjective caregiving burden, and caregiving impact).

  2. Dysfunctional beliefs and attitudes about sleep

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

    It will be measured using the Chinse version of 16-item Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16). DBAS-16 is a 16-item scale.

  3. Emotional distress

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

    It will be measured with the stress, anxiety, and depression scales (DASS-21).

  4. Patient neuropsychiatric symptoms

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

    The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms. NPI evaluates 12 common neuropsychiatric disturbances in dementia.

  5. Dyadic quality of life

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

    It will be measured with the Quality of Life-Alzheimer's Disease Scale (QOL-AD), which will be separately rated by caregivers and care recipients. It is a 13-item, 4-point Likert scale that measures the quality of life for adults w

Study contacts

Contact information is provided by the study sponsor or research team.

Mingyue HU, PhD

CONTACT

+852 54131253

Shanshan WANG, PhD

CONTACT

[email protected]

+852 2766 4696

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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