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E-bibliotherapy for Informal Caregivers of People With Dementia

Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05927805
Enrollment
192
Registered
2023-07-03
Start date
2023-09-30
Completion date
2026-09-30
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Stress Syndrome, Dementia, Psychological Well-Being

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.

Interventions

OTHERE-bibliotherapy

Participants in the intervention group will accept eight weekly sessions of e-bibliotherapy. The e-bibliotherapy will be delivered via the e-bibliotherapy app we develop and includes eight e-bibliotherapy sessions, each focusing on one active component that may affect a caregiver's mental well-being.

OTHERControl

The control group will give access to the same e-bibliotherapy app, but only be authorized to access general daily living knowledge that is different from the intervention contents. They will also be asked to finish a session each week for eight weeks.

Sponsors

Health and Medical Research Fund
CollaboratorOTHER_GOV
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes on psychological well-beingPre-intervention, immediately post-intervention, three and six-month post-interventionPsychological well-being will be measured by the Chinese version of Ryff's Psychological Well-being Scale. It is a 6-point Likert scale with 1=strongly disagree to 6=totally agree. It includes 18 items. A higher score indicates better psychological well-being.

Secondary

MeasureTime frameDescription
Changes on caregiving appraisalPre-intervention, immediately post-intervention, three and six-month post-interventionCaregiving appraisal will be measured by the Chinese version of the Caregiving Appraisal Scale. It is a 5-point Likert scale (1=extremly disagree, 5=strongly agree) including 26 items. Higher scores indicate more positive caregiving appraisal.
Changes on mental healthPre-intervention, immediately post-intervention, three and six-month post-interventionMental health will be measured by the Chinese version of the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 is a 4-point Likert scale (0=totally unfit my condition, 3=very fit my condition). It includes 21 items. Higher scores indicate worse mental health problems.
Changes on biomarker of stressPre-intervention, immediately post-intervention, three and six-month post-interventionSaliva cortisol concentration will be used.
Changes on health-related quality of lifePre-intervention, immediately post-intervention, three and six-month post-interventionHealth-related quality of life will be measured by the 12-item Short Form Survey (SF-12). SF-12 includes 12 items. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026