E-bibliotherapy for Informal Caregivers of People With Dementia

NCT ID: NCT05927805

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Dementia; Caregiver Stress Syndrome; Psychological Well-Being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

Eight weekly sessions of e-bibliotherapy. Participants in the intervention group will use the e-bibliotherapy app we develop, and accept e-bibliotherapy via the app.

Group Type: EXPERIMENTAL

E-bibliotherapy

Intervention Type: OTHER

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 group

Eight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health and Medical Research Fund

OTHER_GOV

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Wang S, Qin J, Cheung DSK, Tyrovolas S, Leung SHI, Leung AYM, Davidson PM. E-bibliotherapy for improving the psychological well-being of informal caregivers of people with dementia: a randomized controlled trial protocol. BMC Nurs. 2024 Feb 1;23(1):84. doi: 10.1186/s12912-024-01706-5.

Reference Type: DERIVED

PMID: 38303009 (View on PubMed)

Other Identifiers

HSEARS20221020009

Identifier Type: -

Identifier Source: org_study_id