E-bibliotherapy for Informal Caregivers of People With Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
E-bibliotherapy
Other interventionParticipants 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
Other interventionThe 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.
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
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.
Time frame
Pre-intervention, immediately post-intervention, three and six-month post-interventionSecondary outcomes
1
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.
Time frame
Pre-intervention, immediately post-intervention, three and six-month post-intervention2
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.
Time frame
Pre-intervention, immediately post-intervention, three and six-month post-intervention3
Changes on biomarker of stress
Saliva cortisol concentration will be used.
Time frame
Pre-intervention, immediately post-intervention, three and six-month post-intervention4
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.
Time frame
Pre-intervention, immediately post-intervention, three and six-month post-interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov
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