Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial

Tajda Laure, Rutger C M E Engels, Danielle Remmerswaal, Donna Spruijt-Metz, Stefan Konigorski, Marilisa Boffo, Tajda Laure, Rutger C M E Engels, Danielle Remmerswaal, Donna Spruijt-Metz, Stefan Konigorski, Marilisa Boffo

Abstract

Background: 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.

Objective: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883.

International registered report identifier (irrid): DERR1-10.2196/46603.

Keywords: emotion regulation; mental health; microrandomized trial; mobile app; mobile intervention; mobile phone; transdiagnostic; university students.

Conflict of interest statement

Conflicts of Interest: TL, RCMEE, DR, and MB are employed by Erasmus University Rotterdam and are directly or indirectly involved in the development of the intervention. All other authors declare no other conflicts of interest.

©Tajda Laure, Rutger C M E Engels, Danielle Remmerswaal, Donna Spruijt-Metz, Stefan Konigorski, Marilisa Boffo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.10.2023.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) flow diagram of participants’ progress through the mixed methods study integrating a microrandomized trial with semistructured interviews. EMA: ecological momentary assessment.

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