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NCT05642364Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
61 (actual)
First submitted
13 Jun 2022
Start date
22 Jun 2023
Primary completion date
5 Feb 2026
Lead sponsor
University of Illinois at Urbana-Champaign
NCT number
NCT05642364

What you commit to

  • Study type: Interventional
  • Participants enrolled: 61
  • From 22 Jun 2023 to the primary completion date, 5 Feb 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 2\) prevalent cognitive impairment denoting dementia
  • 4\) history of epilepsy, seizures, or vertigo.

Other

  • 1\) unavailable for study period
  • 3\) physical limitation restricting use of a head-mounted display

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
DaVita Little Village Dialysis PD
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
DaVita Garfield Kidney Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
UI Health - Dialysis Unit, EEI Suite 2028
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.