DementiaNCT05927805
E-bibliotherapy for Informal Caregivers of People With Dementia
A study testing E-bibliotherapy in people with Dementia and Caregiver Stress Syndrome, run by The Hong Kong Polytechnic University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Caregiver Stress Syndrome, Psychological Well-Being
- What is being tested?
- E-bibliotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled 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.
Read the 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.
- Being tested
- E-bibliotherapy, Control
- Medical subject headings
- Dementia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-bibliotherapyOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Secondary outcomes (4)
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.
Measured: Pre-intervention, immediately post-intervention, three and six-month post-intervention
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.
Measured: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Changes on biomarker of stress
Saliva cortisol concentration will be used.
Measured: Pre-intervention, immediately post-intervention, three and six-month post-intervention
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.
Measured: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927805
- Sponsor's protocol ID
- HSEARS20221020009
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38303009
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05927805
- Acronym / sponsor ID
- HSEARS20221020009
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: E-bibliotherapyEight 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. |
| Control group | Sham comparator | Other: ControlEight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-bibliotherapyParticipants 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 | Intervention group |
| ControlThe 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. | Other | Control group |
Primary outcome
Changes on psychological well-being
Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 38303009Wang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing E-bibliotherapy in people with Dementia and Caregiver Stress Syndrome, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on psychological well-being (time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.