Tajda Laure

Background: University students are facing a multitude of challenges and an increase in mental health issues that affect their academic performance and overall well-being. In response, Erasmus University Rotterdam launched the Student Wellbeing Programme in 2019, offering comprehensive, tailored support through a stepped-care framework to enhance student success and well-being. One of the tools developed for students is ROOM to Grow, an anonymous and accessible preventative mental health app. Objective: This paper describes the process and outcomes of ROOM’s design and development, guided by the Centre for eHealth Research (CeHRes) road map and privacy-by-design principles, and highlights the lessons learned throughout this process. Methods: This paper describes the first 4 phases of the CeHRes Road map: contextual inquiry, value specification, design, and operationalization. It outlines the population (ie, stakeholders), methods (ie, literature reviews, expert groups, cognitive walkthroughs, interviews, experimental designs), and outcomes of each phase. Results: The most common mental health struggles among our target population were stress, anxiety symptoms, perfectionistic tendencies, and loneliness. Students often recognized these issues only once they became overwhelming. Regarding digital tools, students seek credible content specific to their experiences, as well as adaptable and intuitive systems; they are mindful of data privacy and aim to reduce their screen time. ROOM was developed to address the diverse needs and preferences of university students through a transdiagnostic approach to mental health. It targets emotion regulation (ER) skills and self-awareness, which underlie the mental health challenges experienced by our target users. ROOM comprises 26 brief exercises (ie, micro-interventions) that support the development and use of adaptive ER. The exercises incorporate techniques from various therapeutic approaches (ie, self-compassion, positive psychology, mindfulness, cognitive behavioral therapy, and acceptance and commitment therapy) to accommodate students’ diverse content preferences. To help students recognize their struggles earlier, ROOM includes a mood tracker and a self-assessment module with questionnaires that evaluate both traits (eg, perfectionistic tendencies) and states (eg, stress levels), providing personalized feedback. ROOM further implements an intelligent recommender system that connects users to relevant content, enhancing the tool’s personalization and responsiveness to users’ needs. As students aim to minimize screen time, ROOM’s goal is not prolonged app use but the application of ER skills in real life, supported by features that facilitate skill transfer into everyday settings. Finally, ROOM was developed within a “privacy-by-design” framework to address students’ privacy concerns, implementing strict privacy and security regulatory standards. Conclusions: Compromises were necessary to balance user needs, resource constraints, and privacy-by-design and security standards, often limiting ROOM’s interactivity. Other challenges included simplifying complex psychological concepts into brief formats, fostering interdisciplinary collaboration, balancing academic rigor with industry production pace, and operating with fixed resources while maintaining an iterative process. This paper may serve as a primer for designing transdiagnostic, adaptive mental health interventions for youth, blending therapeutic approaches and promoting skill transfer.

Increasing mental health problems among university students highlight the need for scalable, effective solutions. We have developed a transdiagnostic mobile intervention called ROOM, promoting adaptive emotion regulation (ER) skills among university students. Understanding how the intervention works and optimising content and delivery is essential for creating an effective and adaptive system. Therefore, this study aimed to optimise ROOM through a sequential explanatory mixed‐methods design, combining a Micro‐Randomized Trial (MRT), evaluating within‐person effects using repeated randomisation, with user experience interviews. 161 university students (82% females) participated in a 3‐week MRT to assess the intervention proximal outcomes, that is, participants' positive and negative emotional states after completing intervention exercises. Additionally, we evaluated impact on distal outcomes (i.e., distress symptoms and ER skills), and user experience by combining objective (e.g., exercise completion rates) and subjective (e.g., exercise likability and helpfulness ratings) engagement patterns with insights from the semi‐structured interviews (n = 18). Upon receiving the intervention, positive emotional states increased and negative ones decreased. The effect on positive emotional states gradually decreased over time while the effect on negative emotional states remained stable throughout the 3‐week intervention period. Distress symptoms and ER skills either remained stable or improved over the 3 weeks, which indicated the intervention's safety. Overall, engagement patterns and interview data show that the intervention was well received, students enjoyed this study design and found context‐sensitive content recommendations highly relevant.

BACKGROUND University students are facing a multitude of challenges and an increase in mental health issues that affect their academic performance and overall well-being. In response, Erasmus University Rotterdam launched the Student Wellbeing Programme in 2019, offering comprehensive, tailored support through a stepped-care framework to enhance student success and well-being. One of the tools developed for students is ROOM to Grow, an anonymous and accessible preventative mental health app. OBJECTIVE This paper describes the process and outcomes of ROOM’s design and development, guided by the Centre for eHealth Research (CeHRes) road map and privacy-by-design principles, and highlights the lessons learned throughout this process. METHODS This paper describes the first 4 phases of the CeHRes Road map: contextual inquiry, value specification, design, and operationalization. It outlines the population (ie, stakeholders), methods (ie, literature reviews, expert groups, cognitive walkthroughs, interviews, experimental designs), and outcomes of each phase. RESULTS The most common mental health struggles among our target population were stress, anxiety symptoms, perfectionistic tendencies, and loneliness. Students often recognized these issues only once they became overwhelming. Regarding digital tools, students seek credible content specific to their experiences, as well as adaptable and intuitive systems; they are mindful of data privacy and aim to reduce their screen time. ROOM was developed to address the diverse needs and preferences of university students through a transdiagnostic approach to mental health. It targets emotion regulation (ER) skills and self-awareness, which underlie the mental health challenges experienced by our target users. ROOM comprises 26 brief exercises (ie, micro-interventions) that support the development and use of adaptive ER. The exercises incorporate techniques from various therapeutic approaches (ie, self-compassion, positive psychology, mindfulness, cognitive behavioral therapy, and acceptance and commitment therapy) to accommodate students’ diverse content preferences. To help students recognize their struggles earlier, ROOM includes a mood tracker and a self-assessment module with questionnaires that evaluate both traits (eg, perfectionistic tendencies) and states (eg, stress levels), providing personalized feedback. ROOM further implements an intelligent recommender system that connects users to relevant content, enhancing the tool’s personalization and responsiveness to users’ needs. As students aim to minimize screen time, ROOM’s goal is not prolonged app use but the application of ER skills in real life, supported by features that facilitate skill transfer into everyday settings. Finally, ROOM was developed within a “privacy-by-design” framework to address students’ privacy concerns, implementing strict privacy and security regulatory standards. CONCLUSIONS Compromises were necessary to balance user needs, resource constraints, and privacy-by-design and security standards, often limiting ROOM’s interactivity. Other challenges included simplifying complex psychological concepts into brief formats, fostering interdisciplinary collaboration, balancing academic rigor with industry production pace, and operating with fixed resources while maintaining an iterative process. This paper may serve as a primer for designing transdiagnostic, adaptive mental health interventions for youth, blending therapeutic approaches and promoting skill transfer.

Self-management interventions (SMIs) may enhance heart failure (HF) outcomes and address challenges associated with disease management. This study aims to review randomized evidence and identify knowledge gaps in SMIs for adult HF patients. Within the COMPAR-EU project, from 2010 to 2018, we conducted searches in the databases MEDLINE, CINAHL, Embase, Cochrane, and PsycINFO. We performed a descriptive analysis using predefined categories and developed an evidence map of randomized controlled trials (RCTs). We found 282 RCTs examining SMIs for HF patients, comparing two to four interventions, primarily targeting individual patients (97%) globally (34 countries, only 31% from an European country). These interventions involved support techniques such as information sharing (95%) and self-monitoring (62%), often through a mix of in-person and remote sessions (43%). Commonly assessed outcomes included quality of life, hospital admissions, mortality, exercise capacity, and self-efficacy. Few studies have focused on lower socio-economic or minority groups. Nurses (68%) and physicians (30%) were the primary providers, and most studies were at low risk of bias in generating a random sequence for participant allocation; however, the reporting was noticeably unclear of methods used to conceal the allocation process. Our analysis has revealed prevalent support techniques and delivery methods while highlighting methodological challenges. These findings provide valuable insights for researchers, clinicians, and policymakers striving to optimize SMIs for individuals living with HF.

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

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. CLINICALTRIAL ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/46603

Self-management interventions (SMIs) may improve outcomes in Chronic Obstructive Pulmonary Disease (COPD). However, accurate comparisons of their relative effectiveness are challenging, partly due to a lack of clarity and detail regarding the intervention content being evaluated. This study systematically describes intervention components and characteristics in randomized controlled trials (RCTs) related to COPD self-management using the COMPAR-EU taxonomy as a framework, identifying components that are insufficiently incorporated into the design of the intervention or insufficiently reported. Overall, 235 RCTs published between 2010 and 2018, from a systematic review were coded using the taxonomy, which includes 132 components across four domains: intervention characteristics, expected patient (or caregiver) self-management behaviours, patient relevant outcomes, and target population characteristics. Risk of bias was also assessed. Interventions mainly focused on physical activity (67.4%), and condition-specific behaviours like breathing exercise (63.5%), self-monitoring (50.8%), and medication use (33.9%). Support techniques like education and skills-training, self-monitoring, and goal setting (over 35% of the RCTs) were mostly used for this. Emotional-based techniques, problem-solving, and shared decision-making were less frequently reported (less than 15% of the studies). Numerous SMIs components were insufficiently incorporated into the design of COPD SMIs or insufficiently reported. Characteristics like mode of delivery, intensity, location, and providers involved were often not described. Only 8% of the interventions were tailored to the target population’s characteristics. Outcomes that are considered important by patients were hardly taken into account. There is still a lot to improve in both the design and description of SMIs for COPD. Using a framework such as the COMPAR-EU SMI taxonomy may contribute to better reporting and to better informing of replication efforts. In addition, prospective use of the taxonomy for developing and reporting intervention content would further aid in building a cumulative science of effective SMIs in COPD.