Thrive at Home: A Virtual Reality Social Intervention for Older Adults

NCT07835568 | Not Yet Recruiting DMC

• 2 other identifiers: NIH 202603091SB1AG090151-01A1
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Mental Health (Depression); Mental Health and General Well-being; Loneliness; Well Being; Caregiver Burden; Caregiver Wellbeing; Mild Cognitive Impairment(MCI); Alzheimer Dementia (AD); Dementia

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (T1), Week 7 (T2), Week 12 (T3)

Secondary Outcomes (7)

• Global Cognitive Function (MoCA)

  Screening (T0), Week 7 (T2), Week 12 (T3)

• Anxiety Symptoms (GAD-7)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

• Positive and Negative Affect (PANAS)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

• Vitality (Subjective Vitality Scale)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

• Companionship (PROMIS Companionship)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

Other Outcomes (5)

• Exploratory, Family Caregiver: Depressive Symptoms (CES-D)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

• Exploratory, Family Caregiver: Caregiver Burden (BSFC)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

• Exploratory, Family Caregiver: Perceived Stress (PSS)

  Baseline (T1), Week 7 (T2), Week 12 (T3)

Study Arms (2)

VR Intervention Group

EXPERIMENTAL

Participants receive a 6-week VR-based social intervention.

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.

Behavioral: Abbreviated Virtual Reality Social Intervention

Interventions

Abbreviated Virtual Reality Social Intervention BEHAVIORAL

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.

Waitlist Control Group

Full Virtual Reality Social Intervention BEHAVIORAL

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.

VR Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Santa Barbara: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator
• Rendever, Inc.: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Depression; Caregiver Burden; Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Stress, Psychological; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Tamara L Afifi, Ph.D.

  University of California, Santa Barbara

  PRINCIPAL INVESTIGATOR

• Nancy Collins, Ph.D.

  University of California, Santa Barbara

  PRINCIPAL INVESTIGATOR

• Kyle Rand, B.A.

  Rendever, Inc.

  PRINCIPAL INVESTIGATOR

• Jennifer Stamps, Ph.D.

  Rendever, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Stamps, Ph.D.

CONTACT

1 + (847) 693-7254; jennifer@rendever.com

Tamara Afifi, Ph.D.

CONTACT

1 + (805) 679-1812; tafifi@ucsb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary statistician will remain masked until primary outcome analyses are completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Co-Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data and related documentation files will be deposited into the NACDA-OAR repository within one year of the completion of the funded project period, or concurrently with the first publication of primary trial data online. Once deposited, the data will remain available in the repository indefinitely.
• Access Criteria: Data will be deposited and made accessible via the password-protected NACDA-OAR platform to qualified investigators affiliated with institutions maintaining a Federal Wide Assurance (FWA). Data may be utilized strictly for secondary research and public health evaluation. To gain access, users must register with the repository and execute a Data Use Agreement stipulating that they will maintain data confidentiality, adhere to ethical reporting guidelines, protect the dataset against unauthorized access, and strictly prohibit selling or re-distributing the raw data to third parties.