Humanoid Robot vs Treatment as Usual for Loneliness

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Quality of Life; Stress; Anxiety; Loneliness
• Intervention / Treatment: Behavioral: Grace Robot; Behavioral: Treatment as Usual

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual	Behavioral: Treatment as Usual; 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.
Experimental: Humanoid Robot	Behavioral: Grace Robot; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7	Commonly-used validated scale to measure anxiety. Higher scores on this scale mean more symptoms of anxiety.	Baseline and Week 8
EuroQoL-5 Dimensions	Commonly-used validated scale to measure quality of life. Higher scores on this scale mean a better quality of life.	Baseline and Week 8
Change in acute healthcare utilization	Number of hospitalizations and emergency room visits between baseline and primary intervention endpoint.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Lady Davis Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Stress; Loneliness; Long-term Care; Humanoid Robot
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 427283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No