End Stage Kidney DiseaseNCT05642364
Virtual Reality in Hemodialysis to Improve Psychological Well-being
A study testing Joviality(TM) and Inert Virtual Reality in people with End Stage Kidney Disease and Depressive Symptoms, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Kidney Disease, Depressive Symptoms
- What is being tested?
- Joviality(TM) and Inert Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2023to 31 Mar 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) HD patient with at least three months since treatment initiation
- 2) Beck Depression Inventory-II (BDI-II) score ≥11
- 3) age 21 or older
- 4) visual and audio acuity to immerse in our VR world
- 5) fluent in English or Spanish
Who cannot join
- 1) unavailable for study period
- 2) prevalent cognitive impairment denoting dementia
- 3) physical limitation restricting use of a head-mounted display
- 4) history of epilepsy, seizures, or vertigo.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DaVita Little Village Dialysis PD
Chicago, Illinois, 60608
UI Health - Dialysis Unit, EEI Suite 2028
Chicago, Illinois, 60612
DaVita Garfield Kidney Center
Chicago, Illinois, 60624
About this study
Official title: Positive Psychological Intervention Delivered Using Virtual Reality in Hemodialysis Patients With Comorbid Depression: Randomized Controlled Trial Assessing Feasibility and Efficacy Testing
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:
Read more
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.
Read the detailed description
Hemodialysis (HD) is a taxing procedure with extensive illness burden and arduous self-care demands. As such, more than 30% of individuals on HD experience elevated symptoms of depression-and, research shows that comorbid depression is associated with adverse kidney disease outcomes, greater risk of hospitalization, and decreased survival rates. Current interventions to treat depressive symptoms in individuals on HD are resource intensive, infrequently administered, and often involve delivery of psychotherapy by highly-trained clinicians via multiple face-to-face communications. There remains a critical scientific gap for easily disseminatable and efficient strategies to improve emotional well-being profiles of individuals on HD in the U.S. and around the world. 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. For instance, during the module focused on mindfulness/meditation, the investigators will use a head-mounted display to fully immerse and transport individuals on HD to an open field beside a calming stream where they will engage in a 12-minute guided meditation. As such, the investigators propose to conduct a 2-arm randomized controlled trial in which individuals on HD (N=84) will be randomly assigned to receive either the JovialityTM VR-based positive psychological intervention or an active control condition (i.e., 2-dimensional wildlife footage and nature-based settings with inert music). The investigators hypothesize that chairside delivery of psychotherapeutic treatment 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, with lower evident rates for missed HD sessions and lower hospitalizations-all while serving as a more cost-effective and far- reaching platform that will greatly expand dissemination. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to HD patients, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world.
- Conditions
- End Stage Kidney Disease, Depressive Symptoms
- Being tested
- Joviality(TM), Inert Virtual Reality
- Keywords
- Positive psychological intervention, Positive emotion, Virtual reality, Psychotherapy, Technology, Head-mounted display
- Medical subject headings
- Kidney Failure, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joviality(TM)Behavioural
Also called Virtual Reality-based Psychotherapy
5-week positive psychological intervention delivered using 3D virtual reality software that is immersive and uses a head-mounted display
Inert Virtual RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Treatment | Experimental | VR-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. Receives: Behavioral: Joviality(TM) |
| Inert Virtual Reality | Active comparator | 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. 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. Receives: Other: Inert Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
Proportion of potential enrollees who were approached for recruitment.
Measured: Through study completion, an average 6 months.
Feasibility: Retention rates
Defined as completing all post-intervention assessments, categorized as a binary outcome Target: ≥75%
Measured: 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%
Measured: Immediately post-intervention at 5-weeks
Feasibility: Refusal rates
Proportion of potential enrollees who were approached for recruitment but decided not to enroll.
Measured: 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
Measured: Immediately post-intervention at 5-weeks
Secondary outcomes (14)
Depressive symptoms
Depressive symptomatology will be assessed using the Beck Depression Inventory-II. Scores range from 1 to 40 where a higher score indicates worse symptoms of depression.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Kidney Disease and Quality of Life
Kidney Disease and Quality of Life (KDQOL-SF™). The scoring procedure first transforms the raw precoded numeric values of items to a 0-100 possible range, with higher transformed scores reflecting better quality of life.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Number of missed hemodialysis treatment sessions
Research staff will extract information from patient medical records to record the number of missed hemodialysis treatment sessions
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Emergency department visits and/or hospitalizations
Research staff will extract information from patient medical records to record the number of emergency department visits and days of hospitalizations.
Measured: 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
The Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms (range values: 28- 140) will serve as an additional measure to triangulate findings of the Beck Depression Inventory-II.
A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for anxiety
The PROMIS adaptive measures for anxiety (range values: 29-145) will be used. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for perceived stress
The PROMIS adaptive measures for perceived stress (range values: 29-145) will be used.
A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for life satisfaction
The PROMIS adaptive measures for life satisfaction (range values: 10-60) will be used. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for positive affect
The PROMIS adaptive measures for positive affect (range values: 34-170) will be used.
A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for life meaning and purpose
The PROMIS adaptive measures for life meaning and purpose (range values 4-60) will be used. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for self-efficacy for managing emotions in the context of a chronic condition
The PROMIS adaptive measures for self-efficacy for managing emotions in the context of a chronic condition (range values: 25-125) will be used. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the 7-item State Optimism Measure
Additional measures of psychological well-being will include the optimism using the 7-item State Optimism Measure. Scoring is mean score of items 1-7 with a higher score indicating greater state optimism.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the Emotional Vitality Measure
Additional measures of psychological well-being will also include emotional vitality (range values 0-110), as measured using select items of the General Well-being Schedule. There are three proposed cut-points: total scores of 0-60 reflect "severe distress", 61-72 "moderate distress" and 73-110 "positive well-being"
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the Flourishing Index
The "Flourish" measure is obtained by summing the scores from each of the first five domains. The "Secure Flourish" measure is obtained by summing the scores from all six domains including the financial and material stability domain. Each of the questions is assessed on a scale of 0-10.
The secure flourishing index score is obtained by summing the scores from the twelve questions in all six domains and results in a score from 0 - 120. Often, for purposes of interpretation, the flourishing and secure flourishing scores are reported as averages of the questions (rather than sums) so that all scores are on a scale of 0-10.
Measured: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start22 Jun 2023
- Primary completion5 Feb 2026
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized controlled trial, inclusive of treatment group and attention-control condition
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Illinois Chicago
- Responsible party
- Principal investigator, Rosalba Hernandez, University of Illinois at Urbana-Champaign
- Investigators
- Rosalba Hernandez, PhD, Principal investigator, University of Illinois Urbana-ChampaignSandraluz Lara-Cinisomo, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642364
- Sponsor's protocol ID
- 5R01DK129594
- Other IDs
- 5R01DK129594
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37327026
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychological Intervention Delivered Using Virtual Reality in Hemodialysis Patients With Comorbid Depression: Randomized Controlled Trial Assessing Feasibility and Efficacy Testing
- ClinicalTrials.gov ID
- NCT05642364
- Acronym / sponsor ID
- 5R01DK129594
- Conditions
- End Stage Kidney Disease, Depressive Symptoms
- Keywords
- Positive psychological intervention, Positive emotion, Virtual reality, Psychotherapy, Technology, Head-mounted display
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Illinois Chicago
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Dec 2022 (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 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.
Detailed description
Hemodialysis (HD) is a taxing procedure with extensive illness burden and arduous self-care demands. As such, more than 30% of individuals on HD experience elevated symptoms of depression-and, research shows that comorbid depression is associated with adverse kidney disease outcomes, greater risk of hospitalization, and decreased survival rates. Current interventions to treat depressive symptoms in individuals on HD are resource intensive, infrequently administered, and often involve delivery of psychotherapy by highly-trained clinicians via multiple face-to-face communications. There remains a critical scientific gap for easily disseminatable and efficient strategies to improve emotional well-being profiles of individuals on HD in the U.S. and around the world. 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. For instance, during the module focused on mindfulness/meditation, the investigators will use a head-mounted display to fully immerse and transport individuals on HD to an open field beside a calming stream where they will engage in a 12-minute guided meditation. As such, the investigators propose to conduct a 2-arm randomized controlled trial in which individuals on HD (N=84) will be randomly assigned to receive either the JovialityTM VR-based positive psychological intervention or an active control condition (i.e., 2-dimensional wildlife footage and nature-based settings with inert music). The investigators hypothesize that chairside delivery of psychotherapeutic treatment 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, with lower evident rates for missed HD sessions and lower hospitalizations-all while serving as a more cost-effective and far- reaching platform that will greatly expand dissemination. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to HD patients, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized controlled trial, inclusive of treatment group and attention-control condition
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Treatment | Experimental | Behavioral: Joviality(TM)VR-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 comparator | Other: Inert Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) HD patient with at least three months since treatment initiation
- 2) Beck Depression Inventory-II (BDI-II) score ≥11
- 3) age 21 or older
- 4) visual and audio acuity to immerse in our VR world
- 5) fluent in English or Spanish
Key exclusion criteria (4 listed)
- 1) unavailable for study period
- 2) prevalent cognitive impairment denoting dementia
- 3) physical limitation restricting use of a head-mounted display
- 4) history of epilepsy, seizures, or vertigo.
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 |
|---|---|---|
| Joviality(TM)Also: Virtual Reality-based Psychotherapy5-week positive psychological intervention delivered using 3D virtual reality software that is immersive and uses a head-mounted display | Behavioural | Virtual Reality Treatment |
| Inert Virtual RealityParticipants 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. | Other | Inert Virtual Reality |
Primary outcome
Feasibility: Recruitment
Time frame: Through study completion, an average 6 months.
Proportion of potential enrollees who were approached for recruitment.
Feasibility: Retention rates
Time frame: Post-intervention at 6-months
Defined as completing all post-intervention assessments, categorized as a binary outcome Target: ≥75%
Feasibility: Non-Compliance/Adherence
Time frame: Immediately post-intervention at 5-weeks
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%
Feasibility: Refusal rates
Time frame: Before enrollment
Proportion of potential enrollees who were approached for recruitment but decided not to enroll.
Acceptability as assessed by whether a participant would recommend the JovialityTM software
Time frame: Immediately post-intervention at 5-weeks
Acceptability as measured by whether a participant would recommend JovialityTM to other HD patients (0 definitely not, to 10 definitely yes). Target: ≥8.0
14 secondary outcomes
Depressive symptoms
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Kidney Disease and Quality of Life
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Number of missed hemodialysis treatment sessions
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Emergency department visits and/or hospitalizations
Time frame: 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
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for anxiety
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for perceived stress
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for life satisfaction
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for positive affect
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for life meaning and purpose
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) for self-efficacy for managing emotions in the context of a chronic condition
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the 7-item State Optimism Measure
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the Emotional Vitality Measure
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Psychological well-being measured with the Flourishing Index
Time frame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
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 18 Feb 2026.
- Derived from this study: PubMed 37327026Hernandez 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.
- Individual participant dataSharing planned: Yes. 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.
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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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. This study is not recruiting at the moment.
Rosalba Hernandez, PhD principal investigator
University of Illinois Urbana-Champaign
Sandraluz Lara-Cinisomo, PhD principal investigator
University of Illinois Urbana-Champaign
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joviality(TM) and Inert Virtual Reality in people with End Stage Kidney Disease and Depressive Symptoms, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (time frame: Through study completion, an average 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642364, which also lists 1 linked publication.
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 18 Feb 2026.