Clinical trial NCT05642364: Virtual Reality in Hemodialysis to Improve Psychological Well-being
Official title: Positive Psychological Intervention Delivered Using Virtual Reality in Hemodialysis Patients With Comorbid Depression: Randomized Controlled Trial Assessing Feasibility and Efficacy Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Kidney Disease
Depressive Symptoms
Keywords: Positive psychological intervention
Positive emotion
Virtual reality
Psychotherapy
Technology
Head-mounted display
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Northwestern University
name: University of Illinois at Chicago
First posted: 2022-12-08
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm randomized controlled trial, inclusive of treatment group and attention-control condition
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Recruitment
timeFrame: Through study completion, an average 6 months.
measure: Feasibility: Retention rates
timeFrame: Post-intervention at 6-months
measure: Feasibility: Non-Compliance/Adherence
timeFrame: Immediately post-intervention at 5-weeks
measure: Feasibility: Refusal rates
timeFrame: Before enrollment
measure: Acceptability as assessed by whether a participant would recommend the JovialityTM software
timeFrame: Immediately post-intervention at 5-weeks
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Kidney Disease and Quality of Life
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Number of missed hemodialysis treatment sessions
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Emergency department visits and/or hospitalizations
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for anxiety
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for perceived stress
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for life satisfaction
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for positive affect
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for life meaning and purpose
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for self-efficacy for managing emotions in the context of a chronic condition
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Psychological well-being measured with the 7-item State Optimism Measure
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Psychological well-being measured with the Emotional Vitality Measure
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
measure: Psychological well-being measured with the Flourishing Index
timeFrame: Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois Chicago
name: Rosalba Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: