Positive Psychological Intervention Delivered Using Virtual Reality in Patients on Hemodialysis With Comorbid Depression: Protocol and Design for the Joviality Randomized Controlled Trial.
Positive Psychological Intervention Delivered Using Virtual Reality in Patients on Hemodialysis With Comorbid Depression: Protocol and Design for the Joviality Randomized Controlled Trial.
复制标题
使用虚拟现实的患者在血液透析患有合并症抑郁症的患者中进行了积极的心理干预措施：Joviality随机对照试验的协议和设计。
DOI：
10.2196/45100
复制
发表时间：
2023-06-16
影响因子：
1.7
通讯作者：
中科院分区：
文献类型：
--
作者：
抑郁症在接受血液透析的个体中非常普遍，但很少被发现，而且治疗不足。在本文中，我们介绍了一项随机对照试验（RCT）的方法学细节，旨在测试使用沉浸式虚拟现实（VR）技术对患有抑郁症的血液透析患者进行5周积极心理干预的可行性和初步疗效。我们的目的是描述Joviality试验的协议和设计，其主要目标有2个方面：通过捕获招募率、拒绝率、保留率、不依从率和依从率以及最终用户反馈来确定Joviality VR软件的可行性;并评估抑郁症状、心理健康和痛苦、生活质量、治疗依从性临床生物标志物和全因住院治疗。该2组RCT计划从美国伊利诺伊州芝加哥的多个门诊中心入组84名患有共病抑郁症的血液透析患者。参与者将被随机分配到以下组：基于VR的愉悦积极心理干预或假VR（2D野生动物镜头和基于自然的设置，使用头戴式显示器呈现惰性音乐）。要符合资格，个体必须接受血液透析至少3个月，Beck抑郁量表-II评分≥11（即，表明轻度至重度抑郁症状），年龄≥21岁，英语或西班牙语流利。Joviality VR软件采用敏捷设计原则构建，并融合了完全沉浸式的内容，数字化身和多重交互功能。干预的目标技能包括注意到积极的事件，积极的重新评价，感恩，善良的行为，以及正念或非判断性的意识。主要结果包括可行性和可接受性指标，沿着初步疗效集中在减少抑郁症状。第二和第三结局包括生活质量、治疗依从性、临床生物标志物和全因住院率。有4个评估时间点：基线、干预后即刻、干预后3个月和干预后6个月。我们假设，与注意力控制条件下的受试者相比，随机分配到基于VR的快乐积极心理学治疗组的受试者的抑郁症状和血液透析相关疾病标志物将大幅改善。该RCT由国家糖尿病、消化和肾脏疾病研究所资助，计划于2023年6月开始招募参与者。这项试验将是第一个测试定制的虚拟现实软件，以提供积极的心理干预，椅旁，在血液透析的个人，以减少抑郁症状。在使用主动对照组的RCT背景下，如果证明有效，VR技术可能成为在门诊治疗期间为临床人群提供心理健康规划的有力工具。ClinicalTrials.gov NCT 05642364; https://clinicaltrials.gov/ct2/show/NCT05642364 PRR1-10.2196/45100
Depression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology. We aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations. This 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality 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 or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition. This RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023. This trial will be 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 an RCT using 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. ClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364 PRR1-10.2196/45100
影响因子：
3.9
作者：
Orzechowski W;Buczek W;Szczerba JE;Gellert R;Rydzewski A;Fiderkiewicz B;Żebrowski P;Daniewska D;Kokoszka A
通讯作者：
Kokoszka A