Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Telephone-Coached Sleep Bibliotherapy
BehavioralAn 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
BehavioralParticipants receive an educational booklet containing general health information and weekly check-in telephone calls.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Telephone-Coached Sleep BibliotherapyExperimental treatment 1 intervention
Group B: Educational BookletActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Time frame
Baseline, immediately post-intervention (8 weeks), and 3 months post-interventionOther outcomes
1
Caregiving Appraisal
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).
Time frame
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention2
Dysfunctional beliefs and attitudes about sleep
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.
Time frame
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention3
Emotional distress
It will be measured with the stress, anxiety, and depression scales (DASS-21).
Time frame
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention4
Patient neuropsychiatric symptoms
The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms. NPI evaluates 12 common neuropsychiatric disturbances in dementia.
Time frame
Baseline, immediately post-intervention (8 weeks), and 3 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov