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Virtual Reality in Hemodialysis to Improve Psychological Well-being

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Jan 29, 2026 to Feb 5, 2026
    • Study completion date: Jan 29, 2026 to Mar 31, 2026
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Primary completion date: Jan 30, 2026 to Jan 29, 2026
    • Study completion date: Jan 2027 to Jan 29, 2026
    v3
  4. Notable Primary completion date: Oct 2023 to Jan 30, 2026v2 Show 6 more changesShow less
    • Start date changed from estimate of Jan 2023 to Jun 22, 2023
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 84 to confirmed 61
    • Study sites: 0 to 3
    • Study completion date: Jul 2024 to Jan 2027
    • Eligibility criteria revised
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05642364
Lead Sponsor University of Illinois at Urbana-Champaign
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Illinois at Chicago
Conditions
(from sponsor)
End Stage Kidney Disease, Depressive Symptoms
Related terms Depression, Kidney Failure, Chronic
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov