Virtual Reality in Hemodialysis to Improve Psychological Well-being

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.

Conditions

• End Stage Kidney Disease
• Depressive Symptoms

Interventions

BEHAVIORAL

Joviality(TM)

5-week positive psychological intervention delivered using 3D virtual reality software that is immersive and uses a head-mounted display

OTHER

Inert Virtual Reality

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Northwestern University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Illinois at Urbana-Champaign

  lead OTHER

Principal Investigators

• Rosalba Hernandez, PhD · University of Illinois Urbana-Champaign

• Sandraluz Lara-Cinisomo, PhD · University of Illinois Urbana-Champaign

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-22

Primary Completion

2026-02-05

Completion

2026-03-31

Countries

• United States

Study Locations