Virtual Reality in Hemodialysis to Improve Psychological Well-being

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-22

Study Completion Date

2026-01-29

Brief Summary

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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.

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Detailed Description

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Hemodialysis (HD) is a taxing procedure with extensive illness burden and arduous self-care demands. As such, more than 30% of individuals on HD experience elevated symptoms of depression-and, research shows that comorbid depression is associated with adverse kidney disease outcomes, greater risk of hospitalization, and decreased survival rates. Current interventions to treat depressive symptoms in individuals on HD are resource intensive, infrequently administered, and often involve delivery of psychotherapy by highly-trained clinicians via multiple face-to-face communications. There remains a critical scientific gap for easily disseminatable and efficient strategies to improve emotional well-being profiles of individuals on HD in the U.S. and around the world. 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. For instance, during the module focused on mindfulness/meditation, the investigators will use a head-mounted display to fully immerse and transport individuals on HD to an open field beside a calming stream where they will engage in a 12-minute guided meditation. As such, the investigators propose to conduct a 2-arm randomized controlled trial in which individuals on HD (N=84) will be randomly assigned to receive either the JovialityTM VR-based positive psychological intervention or an active control condition (i.e., 2-dimensional wildlife footage and nature-based settings with inert music). The investigators hypothesize that chairside delivery of psychotherapeutic treatment 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, with lower evident rates for missed HD sessions and lower hospitalizations-all while serving as a more cost-effective and far- reaching platform that will greatly expand dissemination. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to HD patients, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world.

Conditions

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End Stage Kidney Disease Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm randomized controlled trial, inclusive of treatment group and attention-control condition

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will both receive virtual reality exposure, specifically the treatment condition will receive a 5-week VR-based positive psychological intervention and the control arm will be exposed to 2-dimensional wildlife footage and nature-based settings with inert music. The outcome assessor will not be aware of trial arm assignment and will not have interaction with patient enrollees in any other capacity of the trial.

Study Groups

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Virtual Reality Treatment

VR-delivered JovialityTM Sessions: Treatment Group. Participants will interact with a newly-developed VR environment over a 5-week period, during regularly scheduled maintenance HD treatment. Each week, enrollees will be introduced to a new skill, all taught in distinctive VR environments-with immersive sessions lasting no more than 30 minutes. The investigators' 5-week positive psychological intervention covers the following topics: (1) noticing positive events, (2) amplifying positive events, (3) gratitude, (4) behavioral activation, (5) mindfulness/meditation, (6) positive reappraisal, (7) personal strengths, and (8) acts of kindness. Delivery of intervention content will require VR immersion for no more than 30 minutes during each HD session (i.e., 30-min. sessions thrice weekly). VR immersion will only occur chairside when patients are already sedentary and in a seated position during regularly scheduled HD treatment, thus avoiding increased sedentarism.

Group Type EXPERIMENTAL

Joviality(TM)

Intervention Type BEHAVIORAL

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

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. The 'Sham' VR experience has very passive features, such that it mimics viewing content on a large flat screen television. Passive viewing during the 'Sham' VR experience rotates content using twenty different videos and has a duration time that is matched to that of JovialityTM over the 5-week intervention period.

Group Type ACTIVE_COMPARATOR

Inert Virtual Reality

Intervention Type OTHER

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.

Interventions

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Joviality(TM)

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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Virtual Reality-based Psychotherapy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 1\) unavailable for study period
* 2\) prevalent cognitive impairment denoting dementia
* 3\) physical limitation restricting use of a head-mounted display
* 4\) history of epilepsy, seizures, or vertigo.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No