BackgroundLoneliness affects up to 42% of long-term care residents and is associated with poor health outcomes. Humanoid robot interventions hold promise for reducing loneliness and decreasing barriers to social interaction in long-term care settings, such as the current COVID-19 safety measures in many countries, limited mobility, and poor health. We present a protocol describing an assessor-blinded randomized controlled trial comparing the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in long-term care residents.MethodsSeventy-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. We 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. We will also assess the feasibility and acceptability of the intervention using qualitative methods.DiscussionThe proposed study will assess the effects of a social robot on loneliness and other mental health outcomes, as well as the feasibility of the intervention in older adults living in long-term care settings.Trial registrationNCT05423899.

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BackgroundLate-life depression (LLD) affects up to 18% of older adults and has been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression and ameliorating cognitive deficits in older adults. While preliminary findings are promising, a definitive RCT investigating its effects on late life depression and cognition have not yet been conducted. We present a protocol describing a multi-site blinded randomized controlled trial, comparing the effects of MBCT and of an active control, a Health Enhancement Program (HEP), on depressive symptoms, executive functioning, and brain biomarkers of LLD, among several other exploratory outcomes.MethodsTwo-hundred and thirteen (n = 213) patients with LLD will be recruited at various centers in Montreal, QC, Canada. Participants will undergo stratified randomization to either MBCT or HEP intervention groups. We will assess changes in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D17), (2) processing speed and executive functioning, (3) brain biomarkers of LLD (hippocampal volume, default network resting-state functional connectivity and executive network resting-state functional connectivity), and (4) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (8 weeks), and 26 weeks after baseline.DiscussionThe proposed study will assess the clinical potential of MBCT to improve symptoms of depression, as well as examine its impact on cognitive impairments and neurobiological markers, and thus inform its use as a promising adjunct in the treatment of LLD.Clinical trial registrationwww.ClinicalTrials.gov, identifier: NCT05366088.