Humanoid Robot vs Treatment as Usual for Loneliness

Not Applicable

Withdrawn

• Conditions: Quality of Life; Depression; Stress; Loneliness; Anxiety
• Interventions: Behavioral: Treatment as Usual; Behavioral: Grace Robot

• Registration Number: NCT05423899
• Lead Sponsor: Lady Davis Institute

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.

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 Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-09-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Treatment as Usual	-
Humanoid Robot	Grace Robot	-

Primary Outcome Measures

Name	Time	Method
Change in the University of California Los Angeles 3-item Loneliness Scale	Baseline and Week 8	Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.

Secondary Outcome Measures

Name	Time	Method
Change in the Perceived Stress Scale	Baseline and Week 8	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.
Patient Health Questionnaire	Baseline and Week 8	9-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.