Depressive Sympotomssocial robotNCT07531082
Effects of a Salutogenic Strength-based Social Robot-assisted Intervention on the Depressive Symptoms and Sense of Coherence of Family Caregivers of Persons With Dementia
A study testing A salutogenic strength-based, robot-assisted intervention in people with Depressive Sympotoms, run by The Hong Kong Polytechnic University.
Trial summary
Family caregivers of persons with dementia (PwD) are well known to be "invisible patients." Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Sympotoms
- What is being tested?
- A salutogenic strength-based, robot-assisted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2029
- 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
- those aged 18 years or older;
- family caregivers of PwD who had been clinically diagnosed;
- are living in the same household as the PwD;
- providing daily caregiving for ≥ 4 hours /day;
- have mild-to-moderate depressive symptoms (PHQ-9 score of 5-14) (Yu et al., 2012); and
- are able to speak Cantonese.
Who cannot join
- those who have been diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression in an acute stage;
- those with a visual or hearing impairment that would interfere with the use of a robot;
- those currently using a social robot at home; and
- who have limited access to electricity at home.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Family caregivers of persons with dementia (PwD) are well known to be "invisible patients." Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. However, few interventions are available to enhance the SOC and thereby the emotional and psychological health of this population. While in-home social robots are viewed as a useful addition to caring for PwD, the use of social robots with family caregivers as the primary audience are vastly under-investigated. In response, the investigators have developed a strength-based, robot-assisted intervention based on Antonovsky's theory of saluotogenesis for family caregivers of PwD. The feasibility, acceptability, and preliminary effects of the robot on family caregivers of PwD have been confirmed, with recommendations for examining its applicability among this population in a full trial.
This study aims to examine the effects of a salutogenic strength-based, robot-assisted intervention on improving depressive symptoms in family caregivers of PwD. This is a mixed-methods study, including a prospective, single-blinded, two-arm parallel randomized controlled trial and semi-structured individual interviews. A group of 148 family caregivers of PwD will be randomized to the intervention group (IG) or the control group (CG), who will receive reading materials on dementia care weekly. Each IG participant will engage with a robot integrated with an AI-powered chatbot at home for 6 weeks. Individual interviews will be conducted at week-6. Purposive sampling will be used to ensure diversity among the participants. Descriptive statistics, t-test and/or Chi square test, generalized estimating equation (GEE), linear regression and thematic analysis will be used.
Read more
Primary hypothesis: Participants in the intervention group (IG) will report a greater improvement in depressive symptoms than the control group (CG) immediately postintervention at 6 weeks (T1), 1-month (T2) and 3-month (T3) after completing the intervention.
Secondary hypothesis: 1) Participants in the IG will report a greater improvement in SOC, perceived caregiving burden, coping, and caregiving self-efficacy than the CG at T1, T2, and T3; 2) The frequency of engaging with specific robot features is associated with improved depressive symptoms, SOC, caregiving burden, coping, and caregiving self-efficacy.
The findings may: 1) advance the understanding of the application of the salutogenesis theory to robotic technology, 2) boost the inner strength of family caregivers to maintain their emotional and psychological health in stressful situations, and provide a new paradigm to strengthen the informal care system.
- Conditions
- Depressive Sympotoms
- Being tested
- A salutogenic strength-based, robot-assisted intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A salutogenic strength-based, robot-assisted interventionBehavioural
A robot pre-set with a salutogenic strength-based intervention will be provided to participants. Each participant will receive a robot placed at home for 6 weeks, operating 24 hours a day and 7 days a week. Participants will be encouraged to engage with KaKa daily, for at least 90 minutes per week.
ControlBehavioural
The group will be provided with reading materials on dementia caregiving weekly.
| Study group | Role | What they receive |
|---|---|---|
| A salutogenic strength-based, robot-assisted intervention | Experimental | A robot pre-set with a salutogenic strength-based intervention will be provided to participants. Each participant will receive a robot placed at home for 6 weeks, operating 24 hours a day and 7 days a week. Participants will be encouraged to engage with KaKa daily, for at least 90 minutes per week. Receives: Behavioral: A salutogenic strength-based, robot-assisted intervention |
| Control group | Placebo comparator | The group will be provided with reading materials on dementia caregiving weekly. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
will be assessed using the Chinese version of the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression. It scores each of the nine diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) for depression as "0" (not at all) to "3" (nearly every day) to assess depression and suicidal ideation in the past 2 weeks. The Chinese version of PHQ-9 has been validated in Hong Kong and was found to have a sensitivity of 80% and a specificity of 92% for diagnosing major depression (Yu et al., 2012).
Measured: From enrollment to 3-month (T3) after completing the intervention
Secondary outcomes (4)
Sense of coherence
will be measured using the Sense of Coherence Scale (Chinese version, C-SOC). It has 3 subscales measuring comprehensibility, manageability, and meaningfulness to an individual. A 1-7 Likert scale will be used, with higher scores indicating stronger SOC in each dimension. The Cronbach's alpha was 0.82, with good construct validity (Ding et al., 2012).
Measured: From enrollment to 3-month (T3) after completing the intervention.
Coping
will be measured using the Simplified Coping Style Questionnaire.It measures on a 0-3 Likert scale the frequency with which positive (12 items) and negative (8 items) coping styles are used (Xie, 1989). A higher composite score represents more effective coping. The Cronbach's alpha was 0.90 and the 2-week test-retest reliability was 0.89 (Xie, 1989).
Measured: From enrollment to 3-month (T3) after completing the intervention.
Perceived caregiving burden
will be assessed using the 22-item Zarit Burden Interview (Chinese version; ZBI-C). It measures caregiving burden on health, psychological well-being, social life, finances, and care dyadic relationships. A 5-point response scale is used, with higher scores indicating a greater perceived burden. The Cronbach's alpha was 0.89, with good concurrent validity (Ko et al., 2008).
Measured: From enrollment to 3-month (T3) after completing the intervention.
Caregiving self-efficacy
will be measured using the Chinese version of the Revised Scale for Caregiving Self-efficacy.It consisted of 3 subscales (5 items per subscale), namely self-efficacy-obtaining respite (SE-OR), self-efficacy-responding to disturbing behaviors (SE-RDB), and self-efficacy-controlling upsetting thoughts (SE-CUT). The average scores of the subscales will be reported separately for each domain. The Cronbach's α for SE-OR, SE-RDB, and SE-CUT were 0.90, 0.93, and 0.92, respectively, for the pretest, and 0.91, 0.96, and 0.96, respectively, for the post-test (Au et al., 2009).
Measured: From enrollment to 3-month (T3) after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SympotomsStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 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
- NCT07531082
- Sponsor's protocol ID
- 15601725
- Acronym
- social robot
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Salutogenic Strength-based Social Robot-assisted Intervention on the Depressive Symptoms and Sense of Coherence of Family Caregivers of Persons With Dementia
- ClinicalTrials.gov ID
- NCT07531082
- Acronym / sponsor ID
- social robot / 15601725
- Conditions
- Depressive Sympotoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 15 Apr 2026 (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.
Family caregivers of persons with dementia (PwD) are well known to be "invisible patients." Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. However, few interventions are available to enhance the SOC and thereby the emotional and psychological health of this population. While in-home social robots are viewed as a useful addition to caring for PwD, the use of social robots with family caregivers as the primary audience are vastly under-investigated. In response, the investigators have developed a strength-based, robot-assisted intervention based on Antonovsky's theory of saluotogenesis for family caregivers of PwD. The feasibility, acceptability, and preliminary effects of the robot on family caregivers of PwD have been confirmed, with recommendations for examining its applicability among this population in a full trial.
This study aims to examine the effects of a salutogenic strength-based, robot-assisted intervention on improving depressive symptoms in family caregivers of PwD. This is a mixed-methods study, including a prospective, single-blinded, two-arm parallel randomized controlled trial and semi-structured individual interviews. A group of 148 family caregivers of PwD will be randomized to the intervention group (IG) or the control group (CG), who will receive reading materials on dementia care weekly. Each IG participant will engage with a robot integrated with an AI-powered chatbot at home for 6 weeks. Individual interviews will be conducted at week-6. Purposive sampling will be used to ensure diversity among the participants. Descriptive statistics, t-test and/or Chi square test, generalized estimating equation (GEE), linear regression and thematic analysis will be used.
Primary hypothesis: Participants in the intervention group (IG) will report a greater improvement in depressive symptoms than the control group (CG) immediately postintervention at 6 weeks (T1), 1-month (T2) and 3-month (T3) after completing the intervention.
Secondary hypothesis: 1) Participants in the IG will report a greater improvement in SOC, perceived caregiving burden, coping, and caregiving self-efficacy than the CG at T1, T2, and T3; 2) The frequency of engaging with specific robot features is associated with improved depressive symptoms, SOC, caregiving burden, coping, and caregiving self-efficacy.
The findings may: 1) advance the understanding of the application of the salutogenesis theory to robotic technology, 2) boost the inner strength of family caregivers to maintain their emotional and psychological health in stressful situations, and provide a new paradigm to strengthen the informal care system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A salutogenic strength-based, robot-assisted intervention | Experimental | Behavioral: A salutogenic strength-based, robot-assisted interventionA robot pre-set with a salutogenic strength-based intervention will be provided to participants. Each participant will receive a robot placed at home for 6 weeks, operating 24 hours a day and 7 days a week. Participants will be encouraged to engage with KaKa daily, for at least 90 minutes per week. |
| Control group | Placebo comparator | Behavioral: ControlThe group will be provided with reading materials on dementia caregiving weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- those aged 18 years or older;
- family caregivers of PwD who had been clinically diagnosed;
- are living in the same household as the PwD;
- providing daily caregiving for ≥ 4 hours /day;
- have mild-to-moderate depressive symptoms (PHQ-9 score of 5-14) (Yu et al., 2012); and
Key exclusion criteria (4 listed)
- those who have been diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression in an acute stage;
- those with a visual or hearing impairment that would interfere with the use of a robot;
- those currently using a social robot at home; and
- who have limited access to electricity at home.
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 |
|---|---|---|
| A salutogenic strength-based, robot-assisted interventionA robot pre-set with a salutogenic strength-based intervention will be provided to participants. Each participant will receive a robot placed at home for 6 weeks, operating 24 hours a day and 7 days a week. Participants will be encouraged to engage with KaKa daily, for at least 90 minutes per week. | Behavioural | A salutogenic strength-based, robot-assisted intervention |
| ControlThe group will be provided with reading materials on dementia caregiving weekly. | Behavioural | Control group |
Primary outcome
Depressive symptoms
Time frame: From enrollment to 3-month (T3) after completing the intervention
will be assessed using the Chinese version of the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression. It scores each of the nine diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) for depression as "0" (not at all) to "3" (nearly every day) to assess depression and suicidal ideation in the past 2 weeks. The Chinese version of PHQ-9 has been validated in Hong Kong and was found to have a sensitivity of 80% and a specificity of 92% for diagnosing major depression (Yu et al., 2012).
4 secondary outcomes
Sense of coherence
Time frame: From enrollment to 3-month (T3) after completing the intervention.
Coping
Time frame: From enrollment to 3-month (T3) after completing the intervention.
Perceived caregiving burden
Time frame: From enrollment to 3-month (T3) after completing the intervention.
Caregiving self-efficacy
Time frame: From enrollment to 3-month (T3) after completing the 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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing A salutogenic strength-based, robot-assisted intervention in people with Depressive Sympotoms, 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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?
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?
Contact Ivy Yan Zhao, PhD (+8527664550, yan-ivy.zhao@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: From enrollment to 3-month (T3) after completing the 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 15 Apr 2026.