JMIR Publications

ABSTRACT

Background:

Depression is highly prevalent in individuals on hemodialysis (HD), but it is infrequently identified and remains undertreated. In the current paper, we present details of a trial aimed at testing feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on HD with comorbid depression, delivered using immersive virtual reality (VR) technology.

Objective:

The objects of the VR-based trial are threefold, as follows: 1) To custom-build VR software to deliver skills of our 5-week evidence-based positive psychological intervention in individuals on HD, 2) Determine feasibility through metrics capturing rates of recruitment, refusal, retention, (non)compliance, adherence, and end-user feedback; and 3) To test preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations.

Methods:

This 2-arm randomized controlled trial (RCT) is scheduled to enroll 84 individuals on HD with comorbid depression from multiple out-patient centers based in Chicago, IL, USA. Enrollees will be randomized to the following groups: 1) VR-based JovialityTM positive psychological intervention; or 2) Sham VR (2-dimensional (2D) wildlife footage and nature-based settings with inert music). To be eligible, individuals must be on HD for at least three months, have Beck Depression Inventory-II scores ≥11 (i.e., indicative of mild to severe depressive symptoms), be aged 21 or older, and fluent in English or Spanish. The JovialityTM VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful awareness/nonjudgement, among others. Primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. Secondary and/or tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are four assessment timepoints: baseline, immediately postintervention, 3-months postintervention, and 6-months postintervention. We hypothesize that depressive symptoms and HD-related markers of disease will significantly improve in participants randomized to the VR-based JovialityTM positive psychology treatment arm compared to the attention control condition.

Results:

The current RCT is funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and is scheduled to launch participant recruitment in February of 2023.

Conclusions:

The current trial is the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of a RCT employing an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions. Clinical Trial: ClinicalTrials.gov (NTC05642364)