Positive Psychological Intervention Delivered Using Virtual Reality in Hemodialysis Patients With Comorbid Depression: Randomized Controlled Trial Assessing Feasibility and Efficacy Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Joviality(TM) (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. 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.
干预措施: Inert Virtual Reality (Other)
结局指标
主要结局
Feasibility: Recruitment
时间窗: Through study completion, an average 6 months.
Proportion of potential enrollees who were approached for recruitment.
Feasibility: Non-Compliance/Adherence
时间窗: Immediately post-intervention at 5-weeks
Measured by the proportion of the intervention completed (e.g., number of virtual reality environments viewed out of the total possible available across skill lessons in the intervention). Target: ≥75%
Feasibility: Retention rates
时间窗: Post-intervention at 6-months
Defined as completing all post-intervention assessments, categorized as a binary outcome Target: ≥75%
Feasibility: Refusal rates
时间窗: Before enrollment
Proportion of potential enrollees who were approached for recruitment but decided not to enroll.
Acceptability as assessed by whether a participant would recommend the JovialityTM software
时间窗: Immediately post-intervention at 5-weeks
Acceptability as measured by whether a participant would recommend JovialityTM to other HD patients (0 definitely not, to 10 definitely yes). Target: ≥8.0
次要结局
- Number of missed hemodialysis treatment sessions(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for perceived stress(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for positive affect(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for life meaning and purpose(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Depressive symptoms(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Kidney Disease and Quality of Life(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Emergency department visits and/or hospitalizations(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for life satisfaction(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Psychological well-being measured with the 7-item State Optimism Measure(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for anxiety(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for self-efficacy for managing emotions in the context of a chronic condition(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Psychological well-being measured with the Emotional Vitality Measure(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
- Psychological well-being measured with the Flourishing Index(Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention))
研究者
Rosalba Hernandez
Associate Professor
University of Illinois at Urbana-Champaign