Dementia CaregiverNCT06413849
Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers
A study testing Telephone coached graphic narrative bibliotherapy in people with Dementia Caregiver and Depressive Symptoms, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia Caregiver, Depressive Symptoms, Caregiving Appraisal
- What is being tested?
- Telephone coached graphic narrative bibliotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- provide unpaid care to a person diagnosed with early to moderate stage dementia;
- provide at least 14 hours of care a week for at least 3 months
- aged 18 years or above
- able to read
- have depressive symptoms
- use a message application
Who cannot join
- with an unstable physical or mental condition
- with cognitive impairment
- receiving medical, psychological, or psychiatric treatment for depression
- have been included in another interventional study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong SAR
Shanshan Wang, 27664696, shan-shan.wang@polyu.edu.hk
About this study
Official title: Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia
This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.
Read the detailed description
This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.
- Being tested
- Telephone coached graphic narrative bibliotherapy, Control group
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone coached graphic narrative bibliotherapyOther
Eight weekly sessions of telephone coached graphic narrative bibliotherapy
Control groupOther
Reading educational booklet
| Study group | Role | What they receive |
|---|---|---|
| Graphic narrative bibliotherapy | Experimental | Eight weekly sessions of telephone-coached graphic narrative bibliotherapy Receives: Other: Telephone coached graphic narrative bibliotherapy |
| Control group | Sham comparator | Reading an educational booklet Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms
Depressive symptoms will be measured with the Chinese version of the Depression Anxiety Stress Scale-21. It is a 4-point Likert scale consisting of 21 items that measure levels ofdepression, anxiety, and stress in participants. The total score ranges from 0-63, with the depression subscale score ranges from 0-21. Higher scores indicategreater severity of mental health problems.
Measured: Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary outcomes (4)
Changes in caregiving appraisal
Caregiving appraisal will be assessed using the Caregiving Appraisal Scale. It is a 26-item Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The score ranges from 26 to 130. Higher scores on this scale indicate more positive caregiving appraisal.
Measured: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in stress and anxiety
Stress and anxiety will be measured with the stress and anxiety subscales of the Depression, anxiety and stress scale-21 (DASS-21). The total score of the full scale ranges from 0-63, with the anxiety and stress subscale score both range from 0-21.
Measured: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in patient neuropsychiatric symptoms
Patient neuropsychiatric symptoms: will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia. The presence of problematic behaviors in each domain is assessed by asking an informant a screening question followed by a series of yes/no questions. The frequency of a symptom is created from 1 (rarely) to 4 (very often), and severity is rated from 1 (mild) to 3 (severe).
Measured: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in quality of life
Quality of life will be measured with the Brief Older People's Quality of Life Questionnaire (OPQOL-Brief). It is a 13-item, 5-point Likert scale to measure the quality of life for older adults. The total score ranges from 13 to 65, with higher scores indicating a better quality of life.
Measured: Pre-intervention, immediately post-intervention, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia CaregiverStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413849
- Sponsor's protocol ID
- P0047108
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia
- ClinicalTrials.gov ID
- NCT06413849
- Acronym / sponsor ID
- P0047108
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2024 (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.
This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.
Detailed description
This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graphic narrative bibliotherapy | Experimental | Other: Telephone coached graphic narrative bibliotherapyEight weekly sessions of telephone-coached graphic narrative bibliotherapy |
| Control group | Sham comparator | Other: Control groupReading an educational booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- provide unpaid care to a person diagnosed with early to moderate stage dementia;
- provide at least 14 hours of care a week for at least 3 months
- aged 18 years or above
- able to read
- have depressive symptoms
Key exclusion criteria (4 listed)
- with an unstable physical or mental condition
- with cognitive impairment
- receiving medical, psychological, or psychiatric treatment for depression
- have been included 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 |
|---|---|---|
| Telephone coached graphic narrative bibliotherapyEight weekly sessions of telephone coached graphic narrative bibliotherapy | Other | Graphic narrative bibliotherapy |
| Control groupReading educational booklet | Other | Control group |
Primary outcome
Changes in depressive symptoms
Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Depressive symptoms will be measured with the Chinese version of the Depression Anxiety Stress Scale-21. It is a 4-point Likert scale consisting of 21 items that measure levels ofdepression, anxiety, and stress in participants. The total score ranges from 0-63, with the depression subscale score ranges from 0-21. Higher scores indicategreater severity of mental health problems.
4 secondary outcomes
Changes in caregiving appraisal
Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in stress and anxiety
Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in patient neuropsychiatric symptoms
Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in quality of life
Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Dementia Caregiver
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Chronic Pain, Alzheimer Disease
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone coached graphic narrative bibliotherapy in people with Dementia Caregiver and Depressive Symptoms, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depressive symptoms (time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.