Buono Frank D, Lalloo Chitra, Larkin Kaitlyn, Zempsky William T, Ball Samuel, Grau Lauretta E, Pham Quynh, Stinson Jennifer
Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
The Research Institute, The Hospital of Sick Children, Toronto, ON, Canada.
Contemp Clin Trials Commun. 2021 Dec 31;25:100883. doi: 10.1016/j.conctc.2021.100883. eCollection 2022 Feb.
Neurofibromatosis Type 1 (NF1) is a genetic disorder presenting with chronic pain symptoms that has limited treatment options for addressing the pain. The utilization of a mobile application allows for greater reach and scalability when using empirically valid psychosocial self-management treatments for pain. The iCanCope mobile application has been utilized in several different populations dealing with pain symptoms and has demonstrated initial effectiveness. To address the need for this population, we have customized the iCanCope mobile application for the NF1 population and included additional tailored features. We describe the rationale and design of a pilot randomized control study with a sample of 108 adults with NF1, in which two groups will receive access to the mobile application, of which one group will be incentivized to engage in the mobile application and the third group will treatment as usual over the course of 8-week period with a six-week follow-up. Outcomes will focus on the acceptability of the iCanCope-NF mobile application within the NF1 population and the impact of pain related activity on psychometric evaluations to determine if the contingency management will impact the engagement of mobile application, as well as to identify the participants' experiences in relationship to their treatment satisfaction and perceived support.
1型神经纤维瘤病（NF1）是一种伴有慢性疼痛症状的遗传性疾病，针对疼痛的治疗选择有限。在使用经实证验证的心理社会自我管理疼痛治疗方法时，移动应用程序的使用可以扩大覆盖面并提高可扩展性。iCanCope移动应用程序已在多个不同的疼痛症状人群中使用，并已显示出初步效果。为满足这一人群的需求，我们为NF1人群定制了iCanCope移动应用程序，并增加了其他定制功能。我们描述了一项针对108名成年NF1患者的试点随机对照研究的基本原理和设计，其中两组将获得该移动应用程序的使用权限，其中一组将被激励使用该移动应用程序，第三组将在为期8周的时间内接受常规治疗，并进行为期6周的随访。结果将聚焦于iCanCope-NF移动应用程序在NF1人群中的可接受性，以及疼痛相关活动对心理测量评估的影响，以确定应急管理是否会影响移动应用程序的使用，以及确定参与者在治疗满意度和感知支持方面的体验。
