Virtual Reality in Hemodialysis to Improve Psychological Well-being
Positive Psychological Intervention Delivered Using Virtual Reality in Hemodialysis Patients With Comorbid Depression: Randomized Controlled Trial Assessing Feasibility and Efficacy Testing
1 other identifier
interventional
61
1 country
3
Brief Summary
The long-term goal is to create behavioral health technologies to advance the science that leverages state-of-the-art technology to delivery psychotherapeutic treatment to individuals on hemodialysis (HD) to improve their emotional well-being, quality of life, and overall health. The objective in this small R01 study is to design a virtual reality (VR) platform, that fully immerses users into a fictitious lifelike environment, to deliver an evidence-based positive psychological intervention and to test whether it improves the emotional well-being of individuals on HD with comorbid depression. In this proposed 2-arm randomized controlled trial, the investigators hypothesize that delivery of psychotherapy in individuals on HD using a VR environment will prove feasible and will result in significant improvements in depressive symptoms, quality of life, and treatment adherence, along with reduced rates of hospitalization when compared to an active control condition-all while serving as a cost-effective and far-reaching platform for expansive dissemination. The Specific Aims are: Aim #1: To develop VR software to immersively deliver the skills taught in a 5-week evidence-based positive psychological intervention in individuals on HD to improve their emotional well-being. Aim #2: To evaluate the acceptability and feasibility of a 5-week positive psychological intervention, delivered using a VR platform through consideration of rates of recruitment, refusal, retention, (non)compliance, and adherence. Aim #3: To test initial efficacy of the VR-based psychotherapeutic intervention, compared to a control arm, on outcomes of depression, psychological well-being, quality of life, treatment adherence, HD sessions missed, and hospitalizations in HD patients. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to individuals on HD, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world. This new therapeutic approach can be used to successfully address the added burden of psychological distress experienced by individuals on HD, with the potential to positively impact their quality of life, engagement in healthful behaviors, and overall healthy longevity. And, these findings will yield data essential for a fully-powered trial testing important health outcomes and biomarkers in individuals on HD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedStudy Start
First participant enrolled
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedFebruary 18, 2026
January 1, 2026
2.6 years
June 13, 2022
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Feasibility: Recruitment
Proportion of potential enrollees who were approached for recruitment.
Through study completion, an average 6 months.
Feasibility: Retention rates
Defined as completing all post-intervention assessments, categorized as a binary outcome Target: ≥75%
Post-intervention at 6-months
Feasibility: Non-Compliance/Adherence
Measured by the proportion of the intervention completed (e.g., number of virtual reality environments viewed out of the total possible available across skill lessons in the intervention). Target: ≥75%
Immediately post-intervention at 5-weeks
Feasibility: Refusal rates
Proportion of potential enrollees who were approached for recruitment but decided not to enroll.
Before enrollment
Acceptability as assessed by whether a participant would recommend the JovialityTM software
Acceptability as measured by whether a participant would recommend JovialityTM to other HD patients (0 definitely not, to 10 definitely yes). Target: ≥8.0
Immediately post-intervention at 5-weeks
Secondary Outcomes (14)
Depressive symptoms
Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Kidney Disease and Quality of Life
Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Number of missed hemodialysis treatment sessions
Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Emergency department visits and/or hospitalizations
Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms
Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
- +9 more secondary outcomes
Study Arms (2)
Virtual Reality Treatment
EXPERIMENTALVR-delivered JovialityTM Sessions: Treatment Group. Participants will interact with a newly-developed VR environment over a 5-week period, during regularly scheduled maintenance HD treatment. Each week, enrollees will be introduced to a new skill, all taught in distinctive VR environments-with immersive sessions lasting no more than 30 minutes. The investigators' 5-week positive psychological intervention covers the following topics: (1) noticing positive events, (2) amplifying positive events, (3) gratitude, (4) behavioral activation, (5) mindfulness/meditation, (6) positive reappraisal, (7) personal strengths, and (8) acts of kindness. Delivery of intervention content will require VR immersion for no more than 30 minutes during each HD session (i.e., 30-min. sessions thrice weekly). VR immersion will only occur chairside when patients are already sedentary and in a seated position during regularly scheduled HD treatment, thus avoiding increased sedentarism.
Inert Virtual Reality
ACTIVE COMPARATORParticipants randomized to the control arm will receive a rigorous placebo following clinical trial guidelines of VR-CORE, which consists of 2-dimensional (2D) non-immersive visual content displayed on the head-mounted display. Footage of wildlife and nature-based settings are visually displayed as part of the 'Sham' VR with inert music that does not promote high levels of relaxation or distraction. The 'Sham' VR experience has very passive features, such that it mimics viewing content on a large flat screen television. Passive viewing during the 'Sham' VR experience rotates content using twenty different videos and has a duration time that is matched to that of JovialityTM over the 5-week intervention period.
Interventions
5-week positive psychological intervention delivered using 3D virtual reality software that is immersive and uses a head-mounted display
Participants randomized to the control arm will receive a rigorous placebo following clinical trial guidelines of VR-CORE, which consists of 2-dimensional (2D) non-immersive visual content displayed on the head-mounted display. Footage of wildlife and nature-based settings are visually displayed as part of the Sham VR with inert music that does not promote high levels of relaxation or distraction.
Eligibility Criteria
You may qualify if:
- \) HD patient with at least three months since treatment initiation
- \) Beck Depression Inventory-II (BDI-II) score ≥11
- \) age 21 or older
- \) visual and audio acuity to immerse in our VR world
- \) fluent in English or Spanish
You may not qualify if:
- \) unavailable for study period
- \) prevalent cognitive impairment denoting dementia
- \) physical limitation restricting use of a head-mounted display
- \) history of epilepsy, seizures, or vertigo.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
DaVita Little Village Dialysis PD
Chicago, Illinois, 60608, United States
UI Health - Dialysis Unit, EEI Suite 2028
Chicago, Illinois, 60612, United States
DaVita Garfield Kidney Center
Chicago, Illinois, 60624, United States
Related Publications (1)
Hernandez R, Wilund K, Solai K, Tamayo D, Fast D, Venkatesan P, Lash JP, Lora CM, Martinez L, Martin Alemany G, Martinez A, Kwon S, Romero D, Browning MHEM, Moskowitz JT. Positive Psychological Intervention Delivered Using Virtual Reality in Patients on Hemodialysis With Comorbid Depression: Protocol and Design for the Joviality Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 16;12:e45100. doi: 10.2196/45100.
PMID: 37327026DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosalba Hernandez, PhD
University of Illinois Urbana-Champaign
- PRINCIPAL INVESTIGATOR
Sandraluz Lara-Cinisomo, PhD
University of Illinois Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will both receive virtual reality exposure, specifically the treatment condition will receive a 5-week VR-based positive psychological intervention and the control arm will be exposed to 2-dimensional wildlife footage and nature-based settings with inert music. The outcome assessor will not be aware of trial arm assignment and will not have interaction with patient enrollees in any other capacity of the trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 13, 2022
First Posted
December 8, 2022
Study Start
June 22, 2023
Primary Completion
February 5, 2026
Study Completion
March 31, 2026
Last Updated
February 18, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IDP and supporting information described above will be made available no later than 12 months after primary completion date.
- Access Criteria
- IDP will be shared through data use agreements created and executed by the University of Illinois Urbana Champaign (UIUC).
Although the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of participants with unusual characteristics. Thus, investigators will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, the investigators will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.