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

NCT07531082 | Not Yet Recruiting

• 1 other identifier: 15601725
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Depressive Sympotoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sense of coherence

  From enrollment to 3-month (T3) after completing the intervention.

• Coping

  From enrollment to 3-month (T3) after completing the intervention.

• Perceived caregiving burden

  From enrollment to 3-month (T3) after completing the intervention.

• Caregiving self-efficacy

  From enrollment to 3-month (T3) after completing the intervention

Study Arms (2)

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.

Behavioral: A salutogenic strength-based, robot-assisted intervention

Control group

PLACEBO COMPARATOR

The group will be provided with reading materials on dementia caregiving weekly.

Behavioral: Control

Interventions

A salutogenic strength-based, robot-assisted intervention BEHAVIORAL

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.

A salutogenic strength-based, robot-assisted intervention

Control BEHAVIORAL

The group will be provided with reading materials on dementia caregiving weekly.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Central Study Contacts

Ivy Yan Zhao, PhD

CONTACT

+8527664550; yan-ivy.zhao@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share