Laure Tajda, Engels Rutger C M E, Remmerswaal Danielle, Spruijt-Metz Donna, Konigorski Stefan, Boffo Marilisa
Department of Psychology, Education, and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University of Rotterdam, Rotterdam, Netherlands.
Dornsife Center for Economic & Social Research, University of Southern California, Los Angeles, CA, United States.
JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603.
Many university students experience mental health problems such as anxiety and depression. To support their mental health, a transdiagnostic mobile app intervention has been developed. The intervention provides short exercises rooted in various approaches (eg, positive psychology, mindfulness, self-compassion, and acceptance and commitment therapy) that aim to facilitate adaptive emotion regulation (ER) to help students cope with the various stressors they encounter during their time at university.
The goals of this study are to investigate whether the intervention and its components function as intended and how participants engage with them. In addition, this study aims to monitor changes in distress symptoms and ER skills and identify relevant contextual factors that may moderate the intervention's impact.
A sequential explanatory mixed methods design combining a microrandomized trial and semistructured interviews will be used. During the microrandomized trial, students (N=200) will be prompted via the mobile app twice a day for 3 weeks to evaluate their emotional states and complete a randomly assigned intervention (ie, an exercise supporting ER) or a control intervention (ie, a health information snippet). A subsample of participants (21/200, 10.5%) will participate in interviews exploring their user experience with the app and the completed exercises. The primary outcomes will be changes in emotional states and engagement with the intervention (ie, objective and subjective engagement). Objective engagement will be evaluated through log data (eg, exercise completion time). Subjective engagement will be evaluated through exercise likability and helpfulness ratings as well as user experience interviews. The secondary outcomes will include the distal outcomes of the intervention (ie, ER skills and distress symptoms). Finally, the contextual moderators of intervention effectiveness will be explored (eg, the time of day and momentary emotional states).
The study commenced on February 9, 2023, and the data collection was concluded on June 13, 2023. Of the 172 eligible participants, 161 (93.6%) decided to participate. Of these 161 participants, 137 (85.1%) completed the first phase of the study. A subsample of participants (18/172, 10.5%) participated in the user experience interviews. Currently, the data processing and analyses are being conducted.
This study will provide insight into the functioning of the intervention and identify areas for improvement. Furthermore, the findings will shed light on potential changes in the distal outcomes of the intervention (ie, ER skills and distress symptoms), which will be considered when designing a follow-up randomized controlled trial evaluating the full-scale effectiveness of this intervention. Finally, the results and data gathered will be used to design and train a recommendation algorithm that will be integrated into the app linking students to relevant content.
ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46603.
许多大学生都经历过焦虑和抑郁等心理健康问题。为了支持他们的心理健康，已开发出一种跨诊断移动应用程序干预措施。该干预措施提供了基于各种方法（如积极心理学、正念、自我同情以及接纳与承诺疗法）的简短练习，旨在促进适应性情绪调节（ER），以帮助学生应对在大学期间遇到的各种压力源。
本研究的目标是调查该干预措施及其组成部分是否按预期发挥作用，以及参与者如何与之互动。此外，本研究旨在监测痛苦症状和情绪调节技能的变化，并确定可能调节干预效果的相关背景因素。
将采用一种序贯解释性混合方法设计，结合微随机试验和半结构化访谈。在微随机试验期间，学生（N = 200）将通过移动应用程序每天被提示两次，持续3周，以评估他们的情绪状态并完成随机分配的干预措施（即支持情绪调节的练习）或对照干预措施（即健康信息片段）。参与者的一个子样本（21/200，10.5%）将参与访谈，探讨他们使用该应用程序和完成练习的用户体验。主要结果将是情绪状态的变化以及对干预措施的参与度（即客观和主观参与度）。客观参与度将通过日志数据（如练习完成时间）进行评估。主观参与度将通过练习的喜爱度和帮助度评分以及用户体验访谈进行评估。次要结果将包括干预措施的远期结果（即情绪调节技能和痛苦症状）。最后，将探索干预效果的背景调节因素（如一天中的时间和瞬间情绪状态）。
该研究于2023年2月9日开始，数据收集于2023年6月13日结束。在172名符合条件的参与者中，161名（93.6%）决定参与。在这161名参与者中，137名（85.1%）完成了研究的第一阶段。参与者的一个子样本（18/172，10.5%）参与了用户体验访谈。目前，正在进行数据处理和分析。
本研究将深入了解该干预措施的功能，并确定改进的领域。此外，研究结果将揭示干预措施远期结果（即情绪调节技能和痛苦症状）的潜在变化，这在设计评估该干预措施全面有效性的后续随机对照试验时将予以考虑。最后，收集到的结果和数据将用于设计和训练一个推荐算法，该算法将被集成到应用程序中，将学生与相关内容相链接。
ClinicalTrials.gov NCT05576883；https://www.clinicaltrials.gov/study/NCT05576883。
国际注册报告识别码（IRRID）：DERR1-10.2196/46603。
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