Caregiver Stress SyndromePhase 2NCT06409455
Positive Dementia Caregiving: Clinical Trial of an Online Training Program
A Phase 2 study testing Positive Dementia Caregiving in 30 Days in people with Caregiver Stress Syndrome, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this study is to learn if a new online training program is helpful to dementia family caregivers. This online program is fully computerized and supports 24/7 access from any location. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Stress Syndrome
- What is being tested?
- Positive Dementia Caregiving in 30 Days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Dec 2024to 30 Sep 2025
- Phase
- Phase 2
- 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
- Having been a dementia caregiver for 3 or more months
- Providing 10 or more hours of care per week
- Scoring 5 or above on the Patient Health Questionnaire-9
- Passing a simple reading comprehension test
Who cannot join
- Caregiver having participated in any training/therapeutic program on dementia care in the past year
- Care-recipient residing in an institution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Dementia Caregiving in 30 Days: Randomized Controlled Trial of a Self-guided Automated Online Training Program
The goal of this study is to learn if a new online training program is helpful to dementia family caregivers. This online program is fully computerized and supports 24/7 access from any location. The main questions it aims to answer are:
- Does the training program improves the participants' well-being and sense of positive meaning?
- If the program is found to be helpful, does it work through enhancing caregivers' self-belief or getting them to practice positive interpretation of caregiving challenges?
Read more
To answer these questions, researchers will compare the online program to a waitlist control.
Participants will:
- Use the intervention (requiring internet access) in a self-guided manner
- Respond to brief questionnaires at the beginning, and 1, 2 and 3 months afterwards
Read the detailed description
The Benefit-Finding Intervention is a type of caregiver intervention called psychoeducation with psychotherapeutic components. It combines standard topics of psychoeducation (e.g., training of care skills and stress management) with training on thinking style. As implied by the title 'benefit-finding', the training style in focus is the inclination to think alternatively and positively about challenging caregiving situations. In two clinical trials, the Benefit-Finding Intervention was compared with didactic psychoeducational programs but without thought training. This comparison allowed researchers to see if the addition of the benefit-finding component produced improvements over the above those achieved by standard psychoeducation. Results supported the superiority of the Benefit-Finding Intervention, with significantly greater reductions of depression and burden up to 10 months after the termination of the intervention.
A face-to-face intervention is nonetheless labor intensive. It may also cause inconvenience to caregivers who have to find blocks of time to attend the intervention, while making sure the care-recipient is being attended to. Having to travel to receive help is another challenge, especially for rural populations and older caregivers. The limitation of the face-to-face format was further exposed during the pandemic when such meetings were simply impossible. To address these issues, the original Benefit-Finding Intervention has been adapted for computer-automated delivery on a web platform, which is accessible anytime anywhere. The online intervention is not meant to replace traditional manned intervention, but as an alternative service for those who, for various reasons, cannot benefit from traditional interventions or who prefer the flexible, self-guided and self-paced approach offered by this intervention.
- Conditions
- Caregiver Stress Syndrome
- Being tested
- Positive Dementia Caregiving in 30 Days
- Keywords
- Family caregiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Dementia Caregiving in 30 DaysBehavioural
Also called Benefit-finding Intervention (Online Version)
Based on an evidence-based face-to-face Benefit-Finding Intervention, a computer-delivered web-based program supporting 24/7 access without location restriction, is developed. It is a psychoeducation program with an emphasis on strengthening caregivers' coping capacity through skills training and developing a positive way of looking at caregiving challenges. The program consists of reading materials, illustrated texts, caregivers' testimonies, a chatbot, and several interactive apps to facilitate self-learning at the caregiver's own pace.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Caregiver training Receives: Behavioral: Positive Dementia Caregiving in 30 Days |
| Waitlist control | Other | Waitlist control Receives: Behavioral: Positive Dementia Caregiving in 30 Days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Patient Health Questionnaire-9; possible scores 0-27, higher = more depressed
Measured: baseline, 1 month, 2 months, 3 months
Secondary outcomes (3)
Anxiety symptoms
Profile of Mood States - Anxiety Subscale, brief version; possible scores 0-24, higher = more anxious
Measured: baseline, 1 month, 2 months, 3 months
Caregiver burden
Zarit Burden Interview, brief version; possible scores 0-24, higher = more burden
Measured: baseline, 1 month, 2 months, 3 months
Positive aspects of caregiving
Positive Aspects of Caregiving Scale, brief version; possible scores 6-30; higher = more positive aspects of caregiving
Measured: baseline, 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start19 Dec 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caregiver Stress SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group (treatment vs. waitlist control) design
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Sheung-Tak Cheng, Education University of Hong Kong
- Investigators
- Sheung-Tak Cheng, PhD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409455
- Sponsor's protocol ID
- 18622322
- Status last verified
- Sep 2025
- First submitted
- 7 May 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Materials will be deposited onto a credible repository.
Publications
Cheng ST, Chan WC, Lam LCW. Long-Term Outcomes of the Benefit-Finding Group Intervention for Alzheimer Family Caregivers: A Cluster-Randomized Double-Blind Controlled Trial. Am J Geriatr Psychiatry. 2019 Sep;27(9):984-994. doi: 10.1016/j.jagp.2019.03.013. Epub 2019 Mar 26.
PubMed 31076215Cheng ST, Mak EPM, Kwok T, Fung H, Lam LCW. Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial. J Gerontol B Psychol Sci Soc Sci. 2020 Oct 16;75(9):1884-1893. doi: 10.1093/geronb/gbz118.
PubMed 31556447
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Dementia Caregiving in 30 Days: Randomized Controlled Trial of a Self-guided Automated Online Training Program
- ClinicalTrials.gov ID
- NCT06409455
- Acronym / sponsor ID
- 18622322
- Conditions
- Caregiver Stress Syndrome
- Keywords
- Family caregiving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 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.
The goal of this study is to learn if a new online training program is helpful to dementia family caregivers. This online program is fully computerized and supports 24/7 access from any location. The main questions it aims to answer are:
- Does the training program improves the participants' well-being and sense of positive meaning?
- If the program is found to be helpful, does it work through enhancing caregivers' self-belief or getting them to practice positive interpretation of caregiving challenges?
To answer these questions, researchers will compare the online program to a waitlist control.
Participants will:
- Use the intervention (requiring internet access) in a self-guided manner
- Respond to brief questionnaires at the beginning, and 1, 2 and 3 months afterwards
Detailed description
The Benefit-Finding Intervention is a type of caregiver intervention called psychoeducation with psychotherapeutic components. It combines standard topics of psychoeducation (e.g., training of care skills and stress management) with training on thinking style. As implied by the title 'benefit-finding', the training style in focus is the inclination to think alternatively and positively about challenging caregiving situations. In two clinical trials, the Benefit-Finding Intervention was compared with didactic psychoeducational programs but without thought training. This comparison allowed researchers to see if the addition of the benefit-finding component produced improvements over the above those achieved by standard psychoeducation. Results supported the superiority of the Benefit-Finding Intervention, with significantly greater reductions of depression and burden up to 10 months after the termination of the intervention.
A face-to-face intervention is nonetheless labor intensive. It may also cause inconvenience to caregivers who have to find blocks of time to attend the intervention, while making sure the care-recipient is being attended to. Having to travel to receive help is another challenge, especially for rural populations and older caregivers. The limitation of the face-to-face format was further exposed during the pandemic when such meetings were simply impossible. To address these issues, the original Benefit-Finding Intervention has been adapted for computer-automated delivery on a web platform, which is accessible anytime anywhere. The online intervention is not meant to replace traditional manned intervention, but as an alternative service for those who, for various reasons, cannot benefit from traditional interventions or who prefer the flexible, self-guided and self-paced approach offered by this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel group (treatment vs. waitlist control) design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Positive Dementia Caregiving in 30 DaysCaregiver training |
| Waitlist control | Other | Behavioral: Positive Dementia Caregiving in 30 DaysWaitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been a dementia caregiver for 3 or more months
- Providing 10 or more hours of care per week
- Scoring 5 or above on the Patient Health Questionnaire-9
- Passing a simple reading comprehension test
Key exclusion criteria (2 listed)
- Caregiver having participated in any training/therapeutic program on dementia care in the past year
- Care-recipient residing in an institution
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 |
|---|---|---|
| Positive Dementia Caregiving in 30 DaysAlso: Benefit-finding Intervention (Online Version)Based on an evidence-based face-to-face Benefit-Finding Intervention, a computer-delivered web-based program supporting 24/7 access without location restriction, is developed. It is a psychoeducation program with an emphasis on strengthening caregivers' coping capacity through skills training and developing a positive way of looking at caregiving challenges. The program consists of reading materials, illustrated texts, caregivers' testimonies, a chatbot, and several interactive apps to facilitate self-learning at the caregiver's own pace. | Behavioural | Intervention, Waitlist control |
Primary outcome
Depressive symptoms
Time frame: baseline, 1 month, 2 months, 3 months
Patient Health Questionnaire-9; possible scores 0-27, higher = more depressed
3 secondary outcomes
Anxiety symptoms
Time frame: baseline, 1 month, 2 months, 3 months
Caregiver burden
Time frame: baseline, 1 month, 2 months, 3 months
Positive aspects of caregiving
Time frame: baseline, 1 month, 2 months, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 31076215Cheng ST, Chan WC, Lam LCW. Long-Term Outcomes of the Benefit-Finding Group Intervention for Alzheimer Family Caregivers: A Cluster-Randomized Double-Blind Controlled Trial. Am J Geriatr Psychiatry. 2019 Sep;27(9):984-994. doi: 10.1016/j.jagp.2019.03.013. Epub 2019 Mar 26.
- Background: PubMed 31556447Cheng ST, Mak EPM, Kwok T, Fung H, Lam LCW. Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial. J Gerontol B Psychol Sci Soc Sci. 2020 Oct 16;75(9):1884-1893. doi: 10.1093/geronb/gbz118.
- Individual participant dataSharing planned: Yes. Materials will be deposited onto a credible repository.
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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.
Sheung-Tak Cheng, PhD principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Positive Dementia Caregiving in 30 Days in people with Caregiver Stress Syndrome, run by Education University of Hong Kong 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive symptoms (time frame: baseline, 1 month, 2 months, 3 months). 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 NCT06409455, which also lists 2 linked publications.
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 1 Oct 2025.