E-bibliotherapy for Informal Caregivers of People With Dementia

NCT05927805 | Not Yet Recruiting

• 1 other identifier: HSEARS20221020009
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia; Caregiver Stress Syndrome; Psychological Well-Being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes on caregiving appraisal

  Pre-intervention, immediately post-intervention, three and six-month post-intervention

• Changes on mental health

  Pre-intervention, immediately post-intervention, three and six-month post-intervention

• Changes on biomarker of stress

  Pre-intervention, immediately post-intervention, three and six-month post-intervention

• Changes on health-related quality of life

  Pre-intervention, immediately post-intervention, three and six-month post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: E-bibliotherapy

Control group

SHAM COMPARATOR

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

Other: Control

Interventions

E-bibliotherapy 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.

Intervention group

Control 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Health and Medical Research Fund: collaborator

Related Publications (1)

• 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.

  PMID: 38303009 DERIVED

MeSH Terms

Conditions

Dementia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06