Clinical trial NCT05927805: E-bibliotherapy for Informal Caregivers of People With Dementia
Official title: Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Caregiver Stress Syndrome
Psychological Well-Being
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2023-07-03
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.

Detailed description: This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

Eligibility criteria: Inclusion Criteria:

* primary caregivers aged 18 or above;
* provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4\~6);
* have cared for the care recipient for at least six months;
* assist with at least one of the care recipient's daily activities;
* use a smartphone or tablet;
* can read Chinese.

Exclusion Criteria:

* caregivers with unstable physical or mental conditions;
* have cognitive impairment;
* are undergoing acute treatment or have not yet stabilized on their chronic medication;
* are involved in another interventional study

Primary outcomes:
measure: Changes on psychological well-being
timeFrame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary outcomes:
measure: Changes on caregiving appraisal
timeFrame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
measure: Changes on mental health
timeFrame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
measure: Changes on biomarker of stress
timeFrame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
measure: Changes on health-related quality of life
timeFrame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Other outcomes:
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