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NCT05642364
Virtual Reality in Hemodialysis to Improve Psychological Well-being
Conditions: End Stage Kidney Disease, Depressive Symptoms
Sex: All
Ages: 21 Years – N/A
Phase: NA
Enrollment: 84
Sponsor: University of Illinois at Urbana-Champaign
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.
Eligibility Criteria
Inclusion Criteria:1) HD patient with at least three months since treatment initiation2) Beck Depression Inventory-II (BDI-II) score ≥113) age 21 or older4) visual and audio acuity to immerse in our VR world(5) fluent in English or SpanishExclusion Criteria:1) unavailable for study period2) prevalent cognitive impairment denoting dementia3) physical limitation restricting use of a head-mounted display4) history of epilepsy, seizures, or vertigo.
Source: ClinicalTrials.gov (NCT05642364). StuddyBuddy aggregates publicly available trial information.