LonelinessNCT05423899
Humanoid Robot vs Treatment as Usual for Loneliness
A study testing Grace Robot and Treatment as Usual in people with Loneliness and Depression, run by Lady Davis Institute.
Trial summary
The investigators are aiming to compare the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in older adults living in long-term care, through an assessor-blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Depression, Stress
- What is being tested?
- Grace Robot and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Mar 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- living in a LTC home setting in Montreal
- cognitively healthy, mild cognitive impairment (MCI) or mild dementia (MMSE score of >20/clinical opinion of LTC homes staff members)
- able to provide consent
- loneliness UCLA-3 score of ≥ 6 or more (moderate-severe loneliness).
Who cannot join
- do not speak English
- inability to provide consent
- moderate to severe dementia (MMSE score <18/diagnosis of moderate-severe dementia/clinical opinion of LTC homes staff members)
- significant hearing loss
- acutely unstable medical illnesses, including delirium, acute cerebrovascular/cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months
- high suicide risk (e.g. active suicidal ideation and/or current/recent intent or plan).
About this study
Official title: Humanoid Robot Intervention vs Treatment as Usual For Loneliness in Long-term Care Homes
The investigators are aiming to compare the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in older adults living in long-term care, through an assessor-blinded randomized controlled trial.
Read the detailed description
Seventy-four (n=74) older adults experiencing loneliness in 3 long-term care homes will be randomized 1:1 to an 8-week, twice a week social intervention with the Grace humanoid robot vs. a treatment as usual active control. The investigators will assess change (baseline to week 8) in (1) loneliness (primary outcome), (2) depression severity and (3) stress (secondary outcomes), as well as (4) other exploratory outcomes : anxiety, quality of life and reduction in acute healthcare utilization. The investigators will also assess the feasibility and acceptability of the intervention using qualitative methods.
- Conditions
- Loneliness, Depression, Stress, Anxiety, Quality of Life
- Being tested
- Grace Robot, Treatment as Usual
- Keywords
- Loneliness, Humanoid Robot, Depression, Long-term Care, Stress
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grace RobotBehavioural
The Grace robot was designed by Awakening Health/Hanson Robotics for healthcare settings and to interact with the elderly and those isolated by the COVID-19 pandemic. Grace is a robot with a human-like appearance, which can move, actively listen, engage in conversation and react appropriately to human emotions. Intervention activities will mostly consist of active listening and general discussions about topics of interest (e.g. hobbies, music). The participant will also have the option of other types of interactions with the robot, including robot-led meditation, robot-led light exercise, listening to music and singing. Because loneliness is a subjective experience and does not have a standardized solution, this is a personalized intervention approach. We anticipate that each older adult participant will have different needs and wishes when interacting with the robot, which will allow for a more natural interaction with the robot.
Treatment as UsualBehavioural
The treatment as usual active control group will not receive the robot intervention. The investIgators have deliberately chosen the participating long-term care (LTC) homes due to their high frequency of social interactions for their clients as part of their routine care (e.g. one-on-one and group activities, family interaction, exercise groups) compared to most LTC homes settings, making TAU an active control.
| Study group | Role | What they receive |
|---|---|---|
| Humanoid Robot | Experimental | Not described Receives: Behavioral: Grace Robot |
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the University of California Los Angeles 3-item Loneliness Scale
Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.
Measured: Baseline and Week 8
Secondary outcomes (2)
Change in the Perceived Stress Scale
14-item scale used to measure the degree to which life events are experienced and appraised as stressful. Higher scores on this scale mean higher stress levels.
Measured: Baseline and Week 8
Patient Health Questionnaire
9-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion30 Mar 2023
Why it stopped: Study withdrawn to due issues with insurance of the robot.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423899
- Sponsor's protocol ID
- 427283
- Status last verified
- Oct 2024
- First submitted
- 1 Jun 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan
Publications
Lavin P, Lesage M, Monroe E, Kanevsky M, Gruber J, Cinalioglu K, Rej S, Sekhon H. Humanoid robot intervention vs. treatment as usual for loneliness in long-term care homes: Study protocol for a pilot randomized controlled trial. Front Psychiatry. 2022 Oct 21;13:1003881. doi: 10.3389/fpsyt.2022.1003881. eCollection 2022.
PubMed 36339874
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humanoid Robot Intervention vs Treatment as Usual For Loneliness in Long-term Care Homes
- ClinicalTrials.gov ID
- NCT05423899
- Acronym / sponsor ID
- 427283
- Conditions
- Loneliness, Depression, Stress, Anxiety, Quality of Life
- Keywords
- Loneliness, Humanoid Robot, Depression, Long-term Care, Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn to due issues with insurance of the robot.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 21 Jun 2022 (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 investigators are aiming to compare the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in older adults living in long-term care, through an assessor-blinded randomized controlled trial.
Detailed description
Seventy-four (n=74) older adults experiencing loneliness in 3 long-term care homes will be randomized 1:1 to an 8-week, twice a week social intervention with the Grace humanoid robot vs. a treatment as usual active control. The investigators will assess change (baseline to week 8) in (1) loneliness (primary outcome), (2) depression severity and (3) stress (secondary outcomes), as well as (4) other exploratory outcomes : anxiety, quality of life and reduction in acute healthcare utilization. The investigators will also assess the feasibility and acceptability of the intervention using qualitative methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humanoid Robot | Experimental | Behavioral: Grace Robot |
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- living in a LTC home setting in Montreal
- cognitively healthy, mild cognitive impairment (MCI) or mild dementia (MMSE score of >20/clinical opinion of LTC homes staff members)
- able to provide consent
- loneliness UCLA-3 score of ≥ 6 or more (moderate-severe loneliness).
Key exclusion criteria (6 listed)
- do not speak English
- inability to provide consent
- moderate to severe dementia (MMSE score <18/diagnosis of moderate-severe dementia/clinical opinion of LTC homes staff members)
- significant hearing loss
- acutely unstable medical illnesses, including delirium, acute cerebrovascular/cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months
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 |
|---|---|---|
| Grace RobotThe Grace robot was designed by Awakening Health/Hanson Robotics for healthcare settings and to interact with the elderly and those isolated by the COVID-19 pandemic. Grace is a robot with a human-like appearance, which can move, actively listen, engage in conversation and react appropriately to human emotions. Intervention activities will mostly consist of active listening and general discussions about topics of interest (e.g. hobbies, music). The participant will also have the option of other types of interactions with the robot, including robot-led meditation, robot-led light exercise, listening to music and singing. Because loneliness is a subjective experience and does not have a standardized solution, this is a personalized intervention approach. We anticipate that each older adult participant will have different needs and wishes when interacting with the robot, which will allow for a more natural interaction with the robot. | Behavioural | Humanoid Robot |
| Treatment as UsualThe treatment as usual active control group will not receive the robot intervention. The investIgators have deliberately chosen the participating long-term care (LTC) homes due to their high frequency of social interactions for their clients as part of their routine care (e.g. one-on-one and group activities, family interaction, exercise groups) compared to most LTC homes settings, making TAU an active control. | Behavioural | Treatment as Usual |
Primary outcome
Change in the University of California Los Angeles 3-item Loneliness Scale
Time frame: Baseline and Week 8
Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.
2 secondary outcomes
Change in the Perceived Stress Scale
Time frame: Baseline and Week 8
Patient Health Questionnaire
Time frame: Baseline and Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 36339874Lavin P, Lesage M, Monroe E, Kanevsky M, Gruber J, Cinalioglu K, Rej S, Sekhon H. Humanoid robot intervention vs. treatment as usual for loneliness in long-term care homes: Study protocol for a pilot randomized controlled trial. Front Psychiatry. 2022 Oct 21;13:1003881. doi: 10.3389/fpsyt.2022.1003881. eCollection 2022.
- Individual participant dataSharing planned: No. No IPD sharing plan
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Grace Robot and Treatment as Usual in people with Loneliness and Depression, run by Lady Davis Institute.
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 6 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: withdrawn, as of the sponsor's last update on 16 Apr 2025. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in the University of California Los Angeles 3-item Loneliness Scale (time frame: Baseline and Week 8). 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 NCT05423899, 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 16 Apr 2025.