The goal of this clinical trial is to evaluate whether a virtual reality (VR) based social platform can improve mental health and social connection for older adults who receive in-home care. Specifically, the study aims to determine if the VR program reduces loneliness, depressive symptoms, and boredom while increasing social connection and well-being among older adult participants. It also explores whether access to the VR program reduces caregiver burden and depressive symptoms for family caregivers.
Researchers will compare an immediate-start group to a waitlist control group to assess whether the VR program improves outcomes compared to standard home care alone. Both groups will eventually receive the intervention. Older adult participants will use a VR headset at home to join group activities three times a week. These sessions include social activities with local peers and live-hosted group activities. A family caregiver or home care professional may be present during sessions if needed for support.
Over a 12-week study period, older adult participants will complete three surveys assessing their mood, social connection, and well-being. Family caregivers of participating older adults are also invited to join an optional caregiver substudy. Caregivers who enroll in the substudy will not participate in the VR activities themselves, but will complete three surveys at the same time points over the 12 weeks to share their own well-being and caregiving experiences.
Aged 65 years or older.
Living in a private residence and receiving home care services from a participating provider, with services expected to continue for the duration of the study (approximately 4 months).
Montreal Cognitive Assessment (MoCA) score of 12 or above.
Fluent in English, sufficient to participate in group virtual reality (VR) sessions and complete verbal surveys.
History of severe motion sickness or vertigo.
History of seizures or epilepsy.
Frequent and distressing hallucinations.
Aphasia or other communication barriers preventing verbal participation.
Parallel
Full Virtual Reality Social Intervention
BehavioralParticipants engage in a 6-week VR-based social intervention that includes three (30-min) virtual reality (VR) group activities per week using the Rendever platform. This includes two Rendever Thrive Program social sessions hosted by a community Activity Director and one live RendeverLive, expert-hosted group programming event (e.g., guided virtual tours, music, trivia). All sessions are completed entirely from the participant's home while safely seated.
Abbreviated Virtual Reality Social Intervention
BehavioralFollowing the completion of the primary 6-week control period and primary outcome assessments, waitlist participants receive an abbreviated 4-week version of the VR-based social intervention. Participants engage in three (30-min) group activities per week using the Rendever platform, structured identically to the experimental group but limited to a 4-week duration for exploratory replication purposes. All data collected during this abbreviated 4-week crossover period are monitored for descriptive and hypothesis-generating purposes as detailed in the internal Statistical Analysis Plan, rather than tracked as distinct registry outcome rows.
Depressive Symptoms (CES-D)
Depressive symptoms are assessed with a modified version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 20 items (range: 0 to 100), where higher scores indicate greater depressive symptom severity.
Loneliness (UCLA Loneliness Scale)
Loneliness is assessed with a modified version of the 20-item UCLA Loneliness Scale (Version 3). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 20 items (range: 0 to 100), where higher scores indicate greater subjective loneliness.
Thriving (BIT)
Thriving is assessed with a modified version of the 10-item Brief Inventory of Thriving (BIT). To increase measurement sensitivity, the standard 5-point Likert scale is replaced with a 7-point Likert scale for each item. Total scores are calculated as the mean across all 10 items (range: 1 to 7), where higher scores indicate greater thriving.
Boredom (Short Boredom Proneness Scale)
Boredom is assessed using a modified Short Boredom Proneness Scale. Items are modified to assess state (vs. trait) boredom. Participants respond to 7 items on a 7-point Likert scale. Total scores are calculated as the mean across all 7 items (range: 1 to 7), where higher scores indicate greater state boredom.
Global Cognitive Function (MoCA)
Global cognitive function is assessed with the standard Montreal Cognitive Assessment (MoCA), covering attention, memory, language, and executive function. Items are scored according to standard clinical administration guidelines to derive a single aggregate performance metric. Total scores range from 0 to 30, where higher scores indicate greater overall cognitive function. \[The MoCA was administered at Screening (T0) to confirm study eligibility and serves as the pre-intervention reference point for this measure.\]
Anxiety Symptoms (GAD-7)
Anxiety symptoms are assessed with a modified version of the 7-item Generalized Anxiety Disorder scale (GAD-7). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 7 items (range: 0 to 100), where higher scores indicate greater anxiety symptom severity.
Positive and Negative Affect (PANAS)
Positive and negative affective states are assessed using a customized 12-item scale adapted from the Positive and Negative Affect Schedule (PANAS), comprising 6 positive items and 6 negative items. To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 5-point Likert scale. Two separate subscores - Positive Affect and Negative Affect - are calculated as the mean across the 6 items (range: 0 to 100), where higher scores indicate greater intensity of that dimension. An overall affect balance score is also calculated as the positive subscale mean minus the negative subscale mean (range: -100 to +100), where higher positive scores indicate greater net positive emotional well-being.
Vitality (Subjective Vitality Scale)
Vitality is assessed with a modified 5-item Subjective Vitality Scale. To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 7-point Likert scale. Total scores are calculated as the mean across all 5 items (range: 0 to 100), where higher scores indicate greater vitality.
Exploratory, Family Caregiver: Depressive Symptoms (CES-D)
Depressive symptoms are assessed with a modified version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 20 items (range: 0 to 100), where higher scores indicate greater depressive symptom severity.
Exploratory, Family Caregiver: Caregiver Burden (BSFC)
Caregiver burden is assessed with a modified version of the 28-item Burden Scale for Family Caregivers (BSFC). To increase measurement sensitivity, the standard 4-point Likert scale is replaced with a 7-point Likert scale for each item. Total scores are calculated as the mean across all 28 items (range: 1 to 7), where higher scores indicate greater subjective caregiver burden.
Exploratory, Family Caregiver: Perceived Stress (PSS)
Perceived stress is assessed with a modified version of the 4-item Perceived Stress Scale (PSS-4). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 5-point Likert scale. Total scores are calculated as the mean across all 4 items (range: 0 to 100), where higher scores indicate greater perceived stress.
Exploratory, Family Caregiver: Self-efficacy (Caregiver Empowerment Scale Subscores)
Caregiver self-efficacy is assessed using two subscales from a modified Caregiver Empowerment Scale (CES), comprising 7 items measuring caregiving self-efficacy and 16 items measuring personal self-efficacy in a caregiving context. To increase measurement sensitivity, the standard 5-point Likert scale is replaced with a 7-point Likert scale for each item. Two separate subscores - Caregiving Self-efficacy and Personal Self-efficacy - are calculated as the mean across their respective items (range: 1 to 7 for each subscale), where higher scores indicate greater self-efficacy in that dimension.
Click on the lead sponsor to view all of their trials.
University of California, Santa Barbara
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator
Rendever, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
