Humanoid Robot vs Treatment as Usual for Loneliness

NCT05423899 | Withdrawn

• 1 other identifier: 427283
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Loneliness; Depression; Stress; Anxiety; Quality of Life

Keywords

Loneliness; Humanoid Robot; Depression; Long-term Care; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the Perceived Stress Scale

  Baseline and Week 8

• Patient Health Questionnaire

  Baseline and Week 8

Other Outcomes (3)

• Generalized Anxiety Disorder-7

  Baseline and Week 8

• EuroQoL-5 Dimensions

  Baseline and Week 8

• Change in acute healthcare utilization

  Baseline and Week 8

Study Arms (2)

Humanoid Robot

EXPERIMENTAL

Behavioral: Grace Robot

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Treatment as Usual

Interventions

Grace Robot BEHAVIORAL

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.

Humanoid Robot

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lady Davis Institute: lead

Related Publications (1)

• 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.

  PMID: 36339874 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 21, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 30, 2023
• Last Updated: April 16, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share