LonelinessRoSELLNCT07102017
A Randomized Controlled Trial of Robotic Support for Enhanced Later Life (RoSELL)
A study testing Co-Design LOVOT Intervention and Standard LOVOT Intervention in people with Loneliness and Well-Being, Psychological, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy of a personalized, co-designed robot interaction against a standardized, fixed robot interaction for reducing loneliness, depression, as well as improving self-agency and quality of life in older adults. This is a three-arm randomized controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Well-Being, Psychological, Depression - Major Depressive Disorder
- What is being tested?
- Co-Design LOVOT Intervention and Standard LOVOT Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to 1 Apr 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
The inclusion criteria of this program are: (1) being aged 65 or above, (2) living within the elderly community center for at least 1 month, and (3) being capable of interacting with a robot.
The participants were not eligible if they were: (1) already engaged in other socially assistive robot programs, (2) diagnosed with severe psychiatric problems, (3) bed-bound, or (4) living in an area with no Internet coverage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Socially Supportive Robotic Intervention on Loneliness, Depression, Self-agency and Well-being in Long-term Care Residents: A Three-Arm Randomized Controlled Trial
The purpose of this study is to compare the efficacy of a personalized, co-designed robot interaction against a standardized, fixed robot interaction for reducing loneliness, depression, as well as improving self-agency and quality of life in older adults.
This is a three-arm randomized controlled trial. The study will be conducted at a community center in Fuzhou, China, with 100 participants aged 65+ recruited from the facility. The participants will be randomly assigned to one of three conditions: (1) Co-designed robot (CL) group receiving a personalized robot interaction with a structured co-design ceremony; (2) Standard robot (SL) group interacting with an identical robot without personalization features; or (3) An attention-controlled usual care (CU) group. The intervention comprises 16 sessions (two weekly 20-minute sessions over eight weeks). The primary outcomes are loneliness and depressive symptoms. Secondary outcomes include general self-efficacy, quality of life, as well as staff and participants' perceptions of the robot. Mechanism measures (i.e., engagement, self-disclosure) and manipulation checks (e.g., perceived personal role) will be employed to elucidate the underlying theoretical pathways. Data will be collected at baseline (T0), after the initial 2-week co-design period (T1), post-intervention (T2, Week 8), and at 1-month (T3) and 3-month (T4) follow-ups.
- Being tested
- Co-Design LOVOT Intervention, Standard LOVOT Intervention
- Keywords
- Social isolation, socially assistive robots, loneliness, depression, self-agency, well-being
- Medical subject headings
- Psychological Well-Being, Social Isolation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Design LOVOT InterventionDevice
This arm utilizes the LOVOT robot within a structured protocol designed to foster a unique personal attachment through a co-design ceremony and anthropomorphic framing.
Personalization Ritual (Sessions 1-2): A healthcare professional facilitates a multi-phase personalization ceremony.
Autonomous Interaction (Sessions 3-16): The personalized LOVOT is placed in the participant's room. The robot consistently uses the participant-chosen voice and eye settings.
Standard LOVOT InterventionDevice
This arm uses the identical LOVOT robot for an equivalent duration but deliberately excludes personalization and anthropomorphic framing to isolate the effect of generic robot companionship.
Standardized Introduction (Sessions 1-2): A healthcare professional introduces the LOVOT robot with a fixed, generic configuration.
Neutral Autonomous Interaction (Sessions 3-16): The standard LOVOT is placed in the participant's room. The robot operates with its default outgoing personality and identical sensors (thermal camera, touch, distance) for safe, autonomous movement and recharging.
| Study group | Role | What they receive |
|---|---|---|
| Co-designed robot group | Experimental | This intervention arm involves a proactive companion robot delivered over 16 sessions, with a core emphasis on structured personalization to foster attachment.
Sessions 1-2 (Personalization Ritual): A healthcare professional facilitates a structured, four-phase co-design ceremony.
Sessions 3-16 (Autonomous Interaction): The co-designed robot is placed in the participant's room for autonomous interaction. It uses the personalized settings and exhibits default affectionate behaviors (e.g., approaching, responding to touch). To reinforce the bond, the healthcare professional uses scripted phrases attributing agency and memory to the robot (e.g., "[Robot's Name] remembers you"). Participants are encouraged to add one new "memory" per session for the robot to "store." Receives: Device: Co-Design LOVOT Intervention |
| Standard Robot Group | Experimental | This arm involves the same robot for an equivalent duration and number of sessions as the co-design intervention arm, but without the personalization ritual or anthropomorphic framing.
Sessions 1-2 (Standardized Introduction): A healthcare professional introduces the same robot, demonstrating its three core, pre-programmed functionalities. The robot has a generic, fixed configuration with identical, pre-set eye color and voice pitch for all participants in this arm.
Sessions 3-16 (Neutral, Autonomous Interaction): The standard robot is placed in the participant's room for autonomous interaction. The key differentiator is the deliberately neutral and non-anthropomorphic framing by the healthcare professional Receives: Device: Standard LOVOT Intervention |
| Control | No intervention | All groups will receive the usual community center services. The study district offers standard community-based programming, including group exercises, social events, and recreational activities, all of which are accessible to all residents. Participation is voluntary. To control for attention bias, healthcare professionals will conduct weekly 20-minute individual visits with participants in this group, totaling 16 sessions over the 4-week intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
Measure the loneliness of participants at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4) to assess the sustained effects of the intervention.
Measured: From enrollment to the end of treatment at 24 weeks
Depression
Depressive Symptoms will be assessed using the Chinese version of the 15-item Geriatric Depression Scale (GDS-15) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).
Measured: From enrollment to the end of treatment at 24 weeks.
Secondary outcomes (2)
Self-Efficacy
General Self-Efficacy will be measured by the Chinese version of the General Self-Efficacy Scale (GSES) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).
Measured: From enrollment to the end of treatment at 24 weeks
Quality of life and Wellbeing
Quality of Life will be evaluated using the WHO-5 Well-Being Index at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start6 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Zhao, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102017
- Sponsor's protocol ID
- L20250617
- Other IDs
- school
- Acronym
- RoSELL
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For protecting user privacy
Publications
Chang F, Muroi F. Personalized versus standardized socially assistive robots for loneliness and depression reduction in older adults: study protocol for a three-arm randomized controlled trial. BMC Geriatr. 2026 Feb 3;26(1):301. doi: 10.1186/s12877-026-07076-8.
PubMed 41634596
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Socially Supportive Robotic Intervention on Loneliness, Depression, Self-agency and Well-being in Long-term Care Residents: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07102017
- Acronym / sponsor ID
- RoSELL / L20250617
- Keywords
- Social isolation, socially assistive robots, loneliness, depression, self-agency, well-being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Aug 2025 (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 purpose of this study is to compare the efficacy of a personalized, co-designed robot interaction against a standardized, fixed robot interaction for reducing loneliness, depression, as well as improving self-agency and quality of life in older adults.
This is a three-arm randomized controlled trial. The study will be conducted at a community center in Fuzhou, China, with 100 participants aged 65+ recruited from the facility. The participants will be randomly assigned to one of three conditions: (1) Co-designed robot (CL) group receiving a personalized robot interaction with a structured co-design ceremony; (2) Standard robot (SL) group interacting with an identical robot without personalization features; or (3) An attention-controlled usual care (CU) group. The intervention comprises 16 sessions (two weekly 20-minute sessions over eight weeks). The primary outcomes are loneliness and depressive symptoms. Secondary outcomes include general self-efficacy, quality of life, as well as staff and participants' perceptions of the robot. Mechanism measures (i.e., engagement, self-disclosure) and manipulation checks (e.g., perceived personal role) will be employed to elucidate the underlying theoretical pathways. Data will be collected at baseline (T0), after the initial 2-week co-design period (T1), post-intervention (T2, Week 8), and at 1-month (T3) and 3-month (T4) follow-ups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-designed robot group | Experimental | Device: Co-Design LOVOT InterventionThis intervention arm involves a proactive companion robot delivered over 16 sessions, with a core emphasis on structured personalization to foster attachment. Sessions 1-2 (Personalization Ritual): A healthcare professional facilitates a structured, four-phase co-design ceremony. Sessions 3-16 (Autonomous Interaction): The co-designed robot is placed in the participant's room for autonomous interaction. It uses the personalized settings and exhibits default affectionate behaviors (e.g., approaching, responding to touch). To reinforce the bond, the healthcare professional uses scripted phrases attributing agency and memory to the robot (e.g., "[Robot's Name] remembers you"). Participants are encouraged to add one new "memory" per session for the robot to "store." |
| Standard Robot Group | Experimental | Device: Standard LOVOT InterventionThis arm involves the same robot for an equivalent duration and number of sessions as the co-design intervention arm, but without the personalization ritual or anthropomorphic framing. Sessions 1-2 (Standardized Introduction): A healthcare professional introduces the same robot, demonstrating its three core, pre-programmed functionalities. The robot has a generic, fixed configuration with identical, pre-set eye color and voice pitch for all participants in this arm. Sessions 3-16 (Neutral, Autonomous Interaction): The standard robot is placed in the participant's room for autonomous interaction. The key differentiator is the deliberately neutral and non-anthropomorphic framing by the healthcare professional |
| Control | No intervention | –All groups will receive the usual community center services. The study district offers standard community-based programming, including group exercises, social events, and recreational activities, all of which are accessible to all residents. Participation is voluntary. To control for attention bias, healthcare professionals will conduct weekly 20-minute individual visits with participants in this group, totaling 16 sessions over the 4-week intervention period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Co-Design LOVOT InterventionThis arm utilizes the LOVOT robot within a structured protocol designed to foster a unique personal attachment through a co-design ceremony and anthropomorphic framing. Personalization Ritual (Sessions 1-2): A healthcare professional facilitates a multi-phase personalization ceremony. Autonomous Interaction (Sessions 3-16): The personalized LOVOT is placed in the participant's room. The robot consistently uses the participant-chosen voice and eye settings. | Device | Co-designed robot group |
| Standard LOVOT InterventionThis arm uses the identical LOVOT robot for an equivalent duration but deliberately excludes personalization and anthropomorphic framing to isolate the effect of generic robot companionship. Standardized Introduction (Sessions 1-2): A healthcare professional introduces the LOVOT robot with a fixed, generic configuration. Neutral Autonomous Interaction (Sessions 3-16): The standard LOVOT is placed in the participant's room. The robot operates with its default outgoing personality and identical sensors (thermal camera, touch, distance) for safe, autonomous movement and recharging. | Device | Standard Robot Group |
Primary outcome
Loneliness
Time frame: From enrollment to the end of treatment at 24 weeks
Measure the loneliness of participants at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4) to assess the sustained effects of the intervention.
Depression
Time frame: From enrollment to the end of treatment at 24 weeks.
Depressive Symptoms will be assessed using the Chinese version of the 15-item Geriatric Depression Scale (GDS-15) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).
2 secondary outcomes
Self-Efficacy
Time frame: From enrollment to the end of treatment at 24 weeks
Quality of life and Wellbeing
Time frame: From enrollment to the end of treatment at 24 weeks
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 19 Nov 2025.
- Derived from this study: PubMed 41634596Chang F, Muroi F. Personalized versus standardized socially assistive robots for loneliness and depression reduction in older adults: study protocol for a three-arm randomized controlled trial. BMC Geriatr. 2026 Feb 3;26(1):301. doi: 10.1186/s12877-026-07076-8.
- Individual participant dataSharing planned: No. For protecting user privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-Design LOVOT Intervention and Standard LOVOT Intervention in people with Loneliness and Well-Being, Psychological, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 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 China. 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.
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?
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?
Loneliness (time frame: From enrollment to the end of treatment at 24 weeks). The study lists 2 primary outcomes in all. 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 NCT07102017, which also lists 1 linked publication.
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 19 Nov 2025.