E-bibliotherapy for Informal Caregivers of People With Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05927805
• Other study ID #: HSEARS20221020009
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Caregiver Stress Syndrome
• Dementia
• Psychological Well-Being

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