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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05927805
Other study ID # HSEARS20221020009
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date September 2026

Study information

Verified date June 2023
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 192
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
E-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.
Control
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Health and Medical Research Fund

Outcome

Type Measure Description Time frame Safety issue
Primary Changes on psychological well-being Psychological 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. Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary Changes on caregiving appraisal Caregiving 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. Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary Changes on mental health Mental 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. Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary Changes on biomarker of stress Saliva cortisol concentration will be used. Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary Changes on health-related quality of life Health-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. Pre-intervention, immediately post-intervention, three and six-month post-intervention
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