User-Centered Development of STOP (Successful Treatment for Paranoia): Material Development and Usability Testing for a Digital Therapeutic for Paranoia.
User-Centered Development of STOP (Successful Treatment for Paranoia): Material Development and Usability Testing for a Digital Therapeutic for Paranoia.
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妄想症是一种严重削弱精神健康的疾病。一种新的治疗偏执狂的干预方法是认知偏执修正偏执症(CBM-pa)。CBM-PA来自于一类专注于操纵解释偏差的干预措施。在这里，我们的目标是开发和评估CBM-PA的新治疗内容，以供以后用于名为STOP(成功治疗偏执狂)的自控数字治疗。本研究的目的是(1)采取以用户为中心的方法，利用生活专家、临床医生和学者的意见来创建和评估与偏执相关的项目内容，以便在Stop中使用；(2)与生活专家和来自数字医疗解决方案公司的设计团队合作，共同创建和中试Stop移动应用原型。我们邀请了18个有过妄想症生活经历的人来创作个人日常情感模棱两可的场景的文本样本，这些场景可能会引发偏执。然后，研究人员将240个合适的样本改编成相应的干预项目，采用CBM训练常用的形式，并创建了240个对照项目用于测试停止。每个项目都包括新开发的、视觉上丰富的图形内容，以增加基本文本场景的参与度和现实感。然后，活着的专家(n=8)和临床医生(n=7)评估了所有条目的偏执严重程度和可读性，研究团队评估了它们的条目长度。根据这些评价，将项目平均分配到六个40个项目的会议中。最终的项目被呈现在Stop移动应用程序中，该应用程序是与一家数字医疗解决方案公司、Living或Living专家以及学术团队共同设计的；用户接受程度通过两项涉及Living或Living专家的试点测试进行评估。所有材料在所有评级标准上都达到了预定义的可接受阈值：偏执严重程度(干预项目：≥1；对照项目：≤1，可读性：≥3，情景长度)，干预组和对照组材料总体上或每组内的单独会话之间没有系统性差异。对于项目图形，我们还发现，在干预和控制组材料之间，用户对复杂性(P=.68)、吸引力(P=.15)和兴趣(P=.14)的评分没有系统性差异。用户对这款移动应用的接受度测试发现，它易于使用和导航，具有互动性，而且很有帮助。任何新的数字疗法的材料开发都需要一个迭代和严格的测试过程，涉及多个贡献团体。适当的以用户为中心的开发可以创建用户友好的移动健康应用程序，这可能会提高脸部有效性，并有更大的机会吸引和接受目标终端用户。
Paranoia is a highly debilitating mental health condition. One novel intervention for paranoia is cognitive bias modification for paranoia (CBM-pa). CBM-pa comes from a class of interventions that focus on manipulating interpretation bias. Here, we aimed to develop and evaluate new therapy content for CBM-pa for later use in a self-administered digital therapeutic for paranoia called STOP (“Successful Treatment of Paranoia”). This study aimed to (1) take a user-centered approach with input from living experts, clinicians, and academics to create and evaluate paranoia-relevant item content to be used in STOP and (2) engage with living experts and the design team from a digital health care solutions company to cocreate and pilot-test the STOP mobile app prototype. We invited 18 people with living or lived experiences of paranoia to create text exemplars of personal, everyday emotionally ambiguous scenarios that could provoke paranoid thoughts. Researchers then adapted 240 suitable exemplars into corresponding intervention items in the format commonly used for CBM training and created 240 control items for the purpose of testing STOP. Each item included newly developed, visually enriching graphics content to increase the engagement and realism of the basic text scenarios. All items were then evaluated for their paranoia severity and readability by living experts (n=8) and clinicians (n=7) and for their item length by the research team. Items were evenly distributed into six 40-item sessions based on these evaluations. Finalized items were presented in the STOP mobile app, which was co-designed with a digital health care solutions company, living or lived experts, and the academic team; user acceptance was evaluated across 2 pilot tests involving living or lived experts. All materials reached predefined acceptable thresholds on all rating criteria: paranoia severity (intervention items: ≥1; control items: ≤1, readability: ≥3, and length of the scenarios), and there was no systematic difference between the intervention and control group materials overall or between individual sessions within each group. For item graphics, we also found no systematic differences in users’ ratings of complexity (P=.68), attractiveness (P=.15), and interest (P=.14) between intervention and control group materials. User acceptance testing of the mobile app found that it is easy to use and navigate, interactive, and helpful. Material development for any new digital therapeutic requires an iterative and rigorous process of testing involving multiple contributing groups. Appropriate user-centered development can create user-friendly mobile health apps, which may improve face validity and have a greater chance of being engaging and acceptable to the target end users.