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E-bibliotherapy for Informal Caregivers of People With Dementia

No phase Interventional Dementia Caregiver Stress Syndrome Psychological Well-Being

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-bibliotherapy, Control.
Who it may be relevant to
Registry conditions: Dementia, Caregiver Stress Syndrome, Psychological Well-Being. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Changes on psychological well-being [Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention]
Secondary outcome measures (4)
  • Changes on caregiving appraisal [Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention]
  • Changes on mental health [Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention]
  • Changes on biomarker of stress [Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention]
  • Changes on health-related quality of life [Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT05927805 · HSEARS20221020009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗