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 (social robot)

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 Overview

• Status: Not yet recruiting
• Conditions: Depressive Sympotoms
• Intervention / Treatment: Behavioral: A salutogenic strength-based, robot-assisted intervention; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivy Yan Zhao, PhD; Phone Number: +8527664550; Email: yan-ivy.zhao@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A salutogenic strength-based, robot-assisted intervention; 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.	Behavioral: A salutogenic strength-based, robot-assisted intervention; 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.
Placebo Comparator: Control group; The group will be provided with reading materials on dementia caregiving weekly.	Behavioral: Control; The group will be provided with reading materials on dementia caregiving weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to 3-month (T3) after completing the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	From enrollment to 3-month (T3) after completing the intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 15601725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No