Carolino Naír, Cunha Marina, Pinto-Gouveia José, Gameiro Sofia, Galhardo Ana
Instituto Superior Miguel Torga, Coimbra, Portugal.
CINEICC-Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.
BMJ Open. 2024 Dec 9;14(12):e087447. doi: 10.1136/bmjopen-2024-087447.
Fertility patients increasingly use web-based and mobile-based apps to access psychosocial care. These digital tools may be a helpful alternative to traditional psychological interventions. Developing and evaluating patient-centred e-mental health tools rooted in evidence-based interventions is a priority. The KindMap is a stand-alone, cost-free e-mental health intervention derived from adapting the Mindfulness Based Programme for Infertility (MBPI) contents to a digital format. The KindMap integrates mindfulness and self-compassion skills training and Acceptance and Commitment Therapy components. This protocol is intended to evaluate the KindMap's feasibility and explore the extent to which the web-app mode of delivery limited efficacy results are similar to the MBPI in-person format results. Furthermore, it will test the causal theory underlying KindMap.
A two-arm 2:1 non-blinded feasibility randomised controlled trial (RCT) will be conducted. Participants are people dealing with infertility, who are able to access the Internet and understand Portuguese or English. Consent participants will complete an online survey at 3-time assessment moments. After baseline assessment, participants will be randomised into the KindMap experimental group (KindMap-EG; with immediate access to the web app) or the waiting-list control group. The primary outcome is well-being (WHO Index-5); secondary outcomes are infertility-related stress (Fertility Problem Inventory-Short Form), anxiety and depression (Patient Health Questionnaire for Depression and Anxiety-4); mindfulness (Five Facet Mindfulness Questionnaire-Short Form), self-compassion (Self-Compassion Scale-Short Form), psychological flexibility (Psy-Flex) and infertility-related self-efficacy are the potential mechanisms of change. KindMap-EG will also complete a feasibility survey.
The study was approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra (Identifier: CEDI/FPCEUC:78/R_10). The KindMap study may contribute to the existing research on e-health technologies applied to mental health. The study outcomes will be disseminated through publications in peer-reviewed journals and national and international conference presentations.
NCT05899374.
生育患者越来越多地使用基于网络和移动设备的应用程序来获得心理社会护理。这些数字工具可能是传统心理干预的有益替代方案。开发和评估以患者为中心、基于循证干预的电子心理健康工具是当务之急。KindMap是一种独立的、免费的电子心理健康干预措施，它是通过将基于正念的不孕症计划（MBPI）的内容改编为数字格式而衍生出来的。KindMap整合了正念和自我同情技能训练以及接纳与承诺疗法的组成部分。本方案旨在评估KindMap的可行性，并探讨网络应用程序交付模式的有限疗效结果在多大程度上与MBPI面对面形式的结果相似。此外，它将检验KindMap背后的因果理论。
将进行一项双臂2:1非盲可行性随机对照试验（RCT）。参与者是正在应对不孕症的人，他们能够访问互联网并理解葡萄牙语或英语。同意参与的参与者将在三个评估时间点完成一项在线调查。在基线评估后，参与者将被随机分为KindMap实验组（KindMap-EG；可立即访问网络应用程序）或等待列表对照组。主要结果是幸福感（世界卫生组织5项指标）；次要结果是不孕症相关压力（不孕症问题简表）、焦虑和抑郁（患者抑郁和焦虑健康问卷-4）；正念（五因素正念简表）、自我同情（自我同情简表）、心理灵活性（Psy-Flex）和不孕症相关自我效能是潜在的变化机制。KindMap-EG还将完成一项可行性调查。
该研究已获得科英布拉大学心理学与教育科学学院伦理委员会的批准（标识符：CEDI/FPCEUC:78/R_10）。KindMap研究可能有助于现有的关于应用于心理健康的电子健康技术的研究。研究结果将通过在同行评审期刊上发表以及在国内和国际会议上展示来传播。
NCT05899374。
