Mental Health (Depression)Thrive at HomeNCT07835568
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
A study testing Full Virtual Reality Social Intervention and Abbreviated Virtual Reality Social Intervention in people with Mental Health (Depression) and Mental Health and General Well-being, run by University of California, Santa Barbara.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health (Depression), Mental Health and General Well-being, Loneliness
- What is being tested?
- Full Virtual Reality Social Intervention and Abbreviated Virtual Reality Social Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- PRIMARY PARTICIPANTS (OLDER ADULTS):
- 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.
- Adequate vision and hearing to complete surveys and engage with VR experiences (mild impairments acceptable if corrected).
Show all 11Show fewer
- Has a family caregiver or home care professional available to support them at every VR session if the MoCA score is below 18 or the participant cannot physically manipulate the headset independently.
- FAMILY CAREGIVERS (OPTIONAL SUBSTUDY):
- Aged 18 years or older.
- Identifies as the primary family caregiver for an enrolled primary participant (living with or visiting the primary participant at least twice per week).
- Fluent in English and able to complete online surveys on a personal digital device (e.g., smartphone, laptop, tablet, or computer).
Who cannot join
- PRIMARY PARTICIPANTS (OLDER ADULTS):
- History of severe motion sickness or vertigo.
- History of seizures or epilepsy.
- Frequent and distressing hallucinations.
- Aphasia or other communication barriers preventing verbal participation.
- Severe disorientation or delirium.
Show all 12Show fewer
- Frequent and severe outbursts or emotional dyscontrol, or frequent and severe aggressive tendencies. (Typical sundowning is not exclusionary.)
- Total vision loss not overcome by VR, or uncorrected hearing impairment that makes group conversation impracticable.
- Residence in a senior living community or other congregate housing.
- Presence of a harmful, aggressive, or abusive relationship with a family caregiver living in the home.
- FAMILY CAREGIVERS (OPTIONAL SUBSTUDY):
- Presence of an aggressive or abusive relationship with the enrolled primary participant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Mental Health and Social Connectivity for Older Adults Through Virtual Reality-Based Social Interventions
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.
Read the detailed description
Approximately 90% of older adults in the United States prefer to age in place at home. However, older adults aging at home may experience social isolation and limited opportunities for meaningful social and cognitive engagement, which are associated with depression, cognitive decline, and increased mortality risk. Although home care services are designed to support physical and daily living needs, they may have limited capacity to provide ongoing social and cognitive engagement. The Thrive at Home study tests whether a networked virtual reality (VR) social platform can help address this gap by connecting older adults receiving home care with one another and with residents of nearby senior living communities.
This is a decentralized, randomized controlled trial using a waitlist control design. Two hundred fifty (250) home-dwelling adults aged 65 and older who are receiving in-home care will be enrolled from home care agency offices across approximately 25 U.S. cities. Participants span the cognitive range from unimpaired through moderate dementia, with a Montreal Cognitive Assessment (MoCA) score of 12 or above required for eligibility. Participants are randomized 1:1 to either Group 1 (Immediate Treatment) or Group 2 (Waitlist Control).
Intervention Timeline \& Dosing:
- Group 1 (Immediate Treatment): Begins the VR social program within 1-3 weeks after baseline and participates for a 6-week primary intervention period, followed by a 4-week monitoring period during which platform access continues and spontaneous use is tracked.
- Group 2 (Waitlist Control): Continues standard home care alone for the first 6 weeks, and then crosses over to receive an abbreviated 4-week version of the VR social program.
Both arms eventually receive the intervention, protecting participant welfare while preserving a rigorous between-group, standard-of-care comparison at the primary 6-week timepoint. The intervention consists of three VR group activities per week: two local social sessions hosted by a community activity director, and one live, expert-hosted session of the participant's choosing. Sessions are conducted entirely from the participant's home while seated. Participants with a MoCA score below 18, or any participant requiring physical assistance, will have a caregiver or home care professional present during sessions for support.
Data Collection \& Endpoint Structure:
Data are collected at three primary milestones: baseline (T1), end of the 6-week primary intervention period (T2, approximately Week 7), and end of the 12-week study period (T3).
- The primary efficacy analyses compare changes from baseline in the immediate intervention group to the waitlist control group at the primary 6-week endpoint (T1 to T2).
- Outcomes assessed at T3 are exploratory; they evaluate treatment replication in the waitlist group (T1 to T3) and long-term maintenance of gains in the immediate intervention group (T2 to T3).
Primary outcomes for older adults (home care clients) include validated measures of depressive symptoms, loneliness, thriving, and boredom. Secondary outcomes include cognitive function, vitality, mental health (anxiety, positive affect, negative affect), social health (companionship, social connectedness), and satisfaction with home care services. Full specification of each measure, instrument, and assessment timepoint is provided in the registry's outcome measure tables.
Additional Exploratory Frameworks:
Beyond the primary and secondary endpoints tracked within the registry tables, this trial incorporates an extensive exploratory framework to evaluate broader psychosocial, behavioral, neuropsychiatric, and technical impacts. These observational and hypothesis-generating metrics will be analyzed and reported in subsequent secondary publications to better understand the holistic mechanisms of the intervention. For the primary participants (older adults), these exploratory dimensions are structured across five core domains:
- Social Network Dynamics \& Relational Health: Assessment of newly formed interpersonal relationships, including the count and nature of new friendships, psychological barriers to social connection, and the individual's motivation, effort, and success in establishing new social ties.
- Psychosocial Well-Being \& Mechanisms of Engagement: Evaluation of sub-domains of mental health, including self-connection, reminiscence behaviors, perceptions of aging and senior living environments, and mid-intervention psychological mediators (such as perceived co-presence, mutual personal disclosure, and group responsiveness).
- Behavioral, Cognitive, \& Digital Biomarkers: Analysis of objective telemetry and speech data, including headset-derived kinesic engagement (movement tracking) and recorded session audio to evaluate vocal and linguistic markers of emotion and memory. Subjective cognitive stimulation and behavioral/neuropsychiatric symptom severity are also tracked.
- Health Status \& System Utilization: Longitudinal tracking of subjective general health ratings and quantitative healthcare resource utilization over the study period.
- Comprehensive User Experience (UX) \& Intervention Feasibility: A robust post-intervention battery evaluating hardware and software usability, physical and cognitive comfort, personal enjoyment, user satisfaction, and long-term platform recommendation metrics.
All unlisted exploratory variables will be managed as purely descriptive and hypothesis-generating analyses, with full parameters specified in the trial's internal protocol and Statistical Analysis Plan (SAP).
Family Caregiver Substudy:
Family caregivers are co-enrolled on a voluntary, non-randomized basis (n ≈ 125) and linked to their primary participant's randomized arm. The caregiver substudy was not included in the trial's power calculations; all caregiver outcomes are analyzed as exploratory, per the Statistical Analysis Plan. For this optional substudy, core exploratory outcomes tracked in the registry include caregiver burden, perceived stress, depressive symptoms, caregiver empowerment (caregiving self-efficacy, and personal self-efficacy), and satisfaction with home care services. Additional exploratory data will be collected and analyzed in subsequent secondary publications regarding broader caregiving relationship dynamics, secondary psychosocial well-being sub-domains, and qualitative intervention feedback. Due to the hypothesis-generating nature of these extended variables, they are fully specified within the internal protocol and SAP rather than listed as individual registry tracking rows.
- Conditions
- Mental Health (Depression), Mental Health and General Well-being, Loneliness, Well Being, Caregiver Burden, Caregiver Wellbeing
- Being tested
- Full Virtual Reality Social Intervention, Abbreviated Virtual Reality Social Intervention
- Keywords
- Randomized controlled trial, Virtual reality (VR), Older adults, Cognitive functioning, Loneliness, Mental health, Thriving, Social connection, Depression, Quality of life, Family caregivers, Caregiver burden, Respite care
- Medical subject headings
- Psychological Well-Being, Depression, Caregiver Burden, Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Virtual Reality Social InterventionBehavioural
Participants 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 InterventionBehavioural
Following 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.
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention Group | Experimental | Participants receive a 6-week VR-based social intervention. Receives: Behavioral: Full Virtual Reality Social Intervention |
| Waitlist Control Group | Other | Participants receive no VR intervention during the initial 6-week randomized period. Following assessment of the primary outcomes, they receive an abbreviated 4-week VR-based social intervention. Receives: Behavioral: Abbreviated Virtual Reality Social Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
Secondary outcomes (7)
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.]
Measured: Screening (T0), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
Companionship (PROMIS Companionship)
Companionship is assessed with a modified version of the 4-item PROMIS Companionship Short Form 4a. 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 companionship.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
Social Connectedness
Social connectedness is assessed with a 15-item multidimensional self-report scale written for this study, which incorporates peer, community, global, and societal connection. Items are rated on a continuous bipolar Global Hedonic Intensity scale ranging from -100 (most unpleasant) through 0 (neutral) to +100 (most pleasurable). Total scores are calculated as the mean across all 15 items (range: -100 to +100), where higher positive scores indicate a greater sense of social connectedness.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
Satisfaction with Home Care Services (CMS HHCAHPS, Adapted)
Satisfaction with home care services is assessed with a 6-item measure adapted from the Centers for Medicare \& Medicaid Services (CMS) Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS). The measure includes items assessing perceived quality of care, overall ratings of care, and willingness to recommend the home care agency. Item responses are converted to a common 0-to-100 scale and averaged to produce a total score ranging from 0 to 100, with higher scores indicating greater satisfaction with home care services.
Measured: Baseline (T1), Week 7 (T2), Week 12 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health (Depression)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a two-arm parallel assignment design to evaluate the primary efficacy of the intervention. Participants are randomized 1:1 to either immediate intervention or a waitlist control group. Primary concurrent between-group outcomes are evaluated at 7 weeks (T2). Following the primary week 7 assessment, the waitlist group crosses over to receive an abbreviated version of the intervention for purely exploratory and descriptive replication purposes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Santa Barbara
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Rendever, Inc.
- Responsible party
- Principal investigator, Nancy Collins, University of California, Santa Barbara
- Investigators
- Tamara L Afifi, Ph.D., Principal investigator, University of California, Santa BarbaraNancy Collins, Ph.D., Principal investigator, University of California, Santa BarbaraKyle Rand, B.A., Principal investigator, Rendever, Inc.Jennifer Stamps, Ph.D., Principal investigator, Rendever, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835568
- Sponsor's protocol ID
- NIH 20260309
- Other IDs
- 1SB1AG090151-01A1
- Acronym
- Thrive at Home
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant quantitative data and related study information underlying the primary and secondary outcomes presented in major peer-reviewed publications will be made available to researchers and data analysts at no cost through the National Archive of Computerized Data on Aging - Open Aging Repository (NACDA-OAR). Specific shared files will include quantitative participant survey responses, comprehensive codebooks, and data dictionaries conforming to NACDA-OAR standard formats. Raw audio recordings, qualitative transcripts, and raw hardware telemetry data are strictly excluded from the shared dataset to protect participant privacy and maintain proprietary technical structures.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health and Social Connectivity for Older Adults Through Virtual Reality-Based Social Interventions
- ClinicalTrials.gov ID
- NCT07835568
- Acronym / sponsor ID
- Thrive at Home / NIH 20260309
- Conditions
- Mental Health (Depression), Mental Health and General Well-being, Loneliness, Well Being, Caregiver Burden, Caregiver Wellbeing
- Keywords
- Randomized controlled trial, Virtual reality (VR), Older adults, Cognitive functioning, Loneliness, Mental health, Thriving, Social connection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, Santa BarbaraUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Rendever, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 90% of older adults in the United States prefer to age in place at home. However, older adults aging at home may experience social isolation and limited opportunities for meaningful social and cognitive engagement, which are associated with depression, cognitive decline, and increased mortality risk. Although home care services are designed to support physical and daily living needs, they may have limited capacity to provide ongoing social and cognitive engagement. The Thrive at Home study tests whether a networked virtual reality (VR) social platform can help address this gap by connecting older adults receiving home care with one another and with residents of nearby senior living communities.
This is a decentralized, randomized controlled trial using a waitlist control design. Two hundred fifty (250) home-dwelling adults aged 65 and older who are receiving in-home care will be enrolled from home care agency offices across approximately 25 U.S. cities. Participants span the cognitive range from unimpaired through moderate dementia, with a Montreal Cognitive Assessment (MoCA) score of 12 or above required for eligibility. Participants are randomized 1:1 to either Group 1 (Immediate Treatment) or Group 2 (Waitlist Control).
Intervention Timeline \& Dosing:
- Group 1 (Immediate Treatment): Begins the VR social program within 1-3 weeks after baseline and participates for a 6-week primary intervention period, followed by a 4-week monitoring period during which platform access continues and spontaneous use is tracked.
- Group 2 (Waitlist Control): Continues standard home care alone for the first 6 weeks, and then crosses over to receive an abbreviated 4-week version of the VR social program.
Both arms eventually receive the intervention, protecting participant welfare while preserving a rigorous between-group, standard-of-care comparison at the primary 6-week timepoint. The intervention consists of three VR group activities per week: two local social sessions hosted by a community activity director, and one live, expert-hosted session of the participant's choosing. Sessions are conducted entirely from the participant's home while seated. Participants with a MoCA score below 18, or any participant requiring physical assistance, will have a caregiver or home care professional present during sessions for support.
Data Collection \& Endpoint Structure:
Data are collected at three primary milestones: baseline (T1), end of the 6-week primary intervention period (T2, approximately Week 7), and end of the 12-week study period (T3).
- The primary efficacy analyses compare changes from baseline in the immediate intervention group to the waitlist control group at the primary 6-week endpoint (T1 to T2).
- Outcomes assessed at T3 are exploratory; they evaluate treatment replication in the waitlist group (T1 to T3) and long-term maintenance of gains in the immediate intervention group (T2 to T3).
Primary outcomes for older adults (home care clients) include validated measures of depressive symptoms, loneliness, thriving, and boredom. Secondary outcomes include cognitive function, vitality, mental health (anxiety, positive affect, negative affect), social health (companionship, social connectedness), and satisfaction with home care services. Full specification of each measure, instrument, and assessment timepoint is provided in the registry's outcome measure tables.
Additional Exploratory Frameworks:
Beyond the primary and secondary endpoints tracked within the registry tables, this trial incorporates an extensive exploratory framework to evaluate broader psychosocial, behavioral, neuropsychiatric, and technical impacts. These observational and hypothesis-generating metrics will be analyzed and reported in subsequent secondary publications to better understand the holistic mechanisms of the intervention. For the primary participants (older adults), these exploratory dimensions are structured across five core domains:
- Social Network Dynamics \& Relational Health: Assessment of newly formed interpersonal relationships, including the count and nature of new friendships, psychological barriers to social connection, and the individual's motivation, effort, and success in establishing new social ties.
- Psychosocial Well-Being \& Mechanisms of Engagement: Evaluation of sub-domains of mental health, including self-connection, reminiscence behaviors, perceptions of aging and senior living environments, and mid-intervention psychological mediators (such as perceived co-presence, mutual personal disclosure, and group responsiveness).
- Behavioral, Cognitive, \& Digital Biomarkers: Analysis of objective telemetry and speech data, including headset-derived kinesic engagement (movement tracking) and recorded session audio to evaluate vocal and linguistic markers of emotion and memory. Subjective cognitive stimulation and behavioral/neuropsychiatric symptom severity are also tracked.
- Health Status \& System Utilization: Longitudinal tracking of subjective general health ratings and quantitative healthcare resource utilization over the study period.
- Comprehensive User Experience (UX) \& Intervention Feasibility: A robust post-intervention battery evaluating hardware and software usability, physical and cognitive comfort, personal enjoyment, user satisfaction, and long-term platform recommendation metrics.
All unlisted exploratory variables will be managed as purely descriptive and hypothesis-generating analyses, with full parameters specified in the trial's internal protocol and Statistical Analysis Plan (SAP).
Family Caregiver Substudy:
Family caregivers are co-enrolled on a voluntary, non-randomized basis (n ≈ 125) and linked to their primary participant's randomized arm. The caregiver substudy was not included in the trial's power calculations; all caregiver outcomes are analyzed as exploratory, per the Statistical Analysis Plan. For this optional substudy, core exploratory outcomes tracked in the registry include caregiver burden, perceived stress, depressive symptoms, caregiver empowerment (caregiving self-efficacy, and personal self-efficacy), and satisfaction with home care services. Additional exploratory data will be collected and analyzed in subsequent secondary publications regarding broader caregiving relationship dynamics, secondary psychosocial well-being sub-domains, and qualitative intervention feedback. Due to the hypothesis-generating nature of these extended variables, they are fully specified within the internal protocol and SAP rather than listed as individual registry tracking rows.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study utilizes a two-arm parallel assignment design to evaluate the primary efficacy of the intervention. Participants are randomized 1:1 to either immediate intervention or a waitlist control group. Primary concurrent between-group outcomes are evaluated at 7 weeks (T2). Following the primary week 7 assessment, the waitlist group crosses over to receive an abbreviated version of the intervention for purely exploratory and descriptive replication purposes.
| Arm | Type | Receives |
|---|---|---|
| VR Intervention Group | Experimental | Behavioral: Full Virtual Reality Social InterventionParticipants receive a 6-week VR-based social intervention. |
| Waitlist Control Group | Other | Behavioral: Abbreviated Virtual Reality Social InterventionParticipants receive no VR intervention during the initial 6-week randomized period. Following assessment of the primary outcomes, they receive an abbreviated 4-week VR-based social intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
- Adequate vision and hearing to complete surveys and engage with VR experiences (mild impairments acceptable if corrected).
Key exclusion criteria (12 listed)
- History of severe motion sickness or vertigo.
- History of seizures or epilepsy.
- Frequent and distressing hallucinations.
- Aphasia or other communication barriers preventing verbal participation.
- Severe disorientation or delirium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Virtual Reality Social InterventionParticipants 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. | Behavioural | VR Intervention Group |
| Abbreviated Virtual Reality Social InterventionFollowing 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. | Behavioural | Waitlist Control Group |
Primary outcome
Depressive Symptoms (CES-D)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
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)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
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)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
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)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
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.
7 secondary outcomes
Global Cognitive Function (MoCA)
Time frame: Screening (T0), Week 7 (T2), Week 12 (T3)
Anxiety Symptoms (GAD-7)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Positive and Negative Affect (PANAS)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Vitality (Subjective Vitality Scale)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Companionship (PROMIS Companionship)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Social Connectedness
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Satisfaction with Home Care Services (CMS HHCAHPS, Adapted)
Time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant quantitative data and related study information underlying the primary and secondary outcomes presented in major peer-reviewed publications will be made available to researchers and data analysts at no cost through the National Archive of Computerized Data on Aging - Open Aging Repository (NACDA-OAR). Specific shared files will include quantitative participant survey responses, comprehensive codebooks, and data dictionaries conforming to NACDA-OAR standard formats. Raw audio recordings, qualitative transcripts, and raw hardware telemetry data are strictly excluded from the shared dataset to protect participant privacy and maintain proprietary technical structures.
Related trials for Mental Health (Depression)
Active, not recruiting
Preventing Anxiety and Depression in Older Hispanics
Depression, Anxiety
Not yet recruitingPhase 2
Psilocybin for Depression in Veterans
Major Depression
Not yet recruitingObservational study
Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara L Afifi, Ph.D. principal investigator
University of California, Santa Barbara
Nancy Collins, Ph.D. principal investigator
University of California, Santa Barbara
Kyle Rand, B.A. principal investigator
Rendever, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Full Virtual Reality Social Intervention and Abbreviated Virtual Reality Social Intervention in people with Mental Health (Depression) and Mental Health and General Well-being, run by University of California, Santa Barbara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Stamps, Ph.D. (1 + (847) 693-7254 ext. Option 2, jennifer@rendever.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (CES-D) (time frame: Baseline (T1), Week 7 (T2), Week 12 (T3)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.