Effectiveness and uptake of a transdiagnostic emotion regulation mobile intervention among university students:Protocol for a randomized controlled trial

Background: Going to university is a major life event, which can be stressful and negatively affect mental health. However, it also presents an opportunity to establish a foundation for positive life trajectories. To support university students, a mobile transdiagnostic emotion regulation (ER) intervention has been developed, offering both broad-based (universal) and targeted (indicated) preventative support. ER, a transdiagnostic factor underlying various mental health problems, is a critical intervention target in students, a demographic particularly susceptible to mental health issues. Cultivating ER can help manage immediate stressors and foster long-term wellbeing. This paper describes the study protocol for a Randomized Controlled Trial (RCT) evaluating the effectiveness and uptake of such mobile transdiagnostic ER intervention. Method: The superiority parallel-group RCT involves 250 participants randomized to either the intervention condition (i.e., full access to the mobile intervention, (n = 125) or to a waitlist control condition (n = 125). Primary outcomes include ER skills and stress symptoms. Secondary outcomes include mental health parameters (anxiety, depression, resilience) and intervention uptake (i.e., objective engagement, subjective engagement, ER skills application in real life). Outcomes are assessed at baseline, week 3, 8 and 12, with continuous log-data collection for user engagement. Discussion: This study evaluates the effectiveness and uptake of a transdiagnostic ER mobile intervention for the student population addressing their ER developmental needs. If successful, the results will validate our approach to intervention development and whether focusing on learning transfer (i.e., application of the learnt skills in real-life) and personalization using a recommendation system, can boost the real-world application of skills and intervention impact.</p

Effectiveness and uptake of a transdiagnostic emotion regulation mobile intervention among university students:Protocol for a randomized controlled trial

Background: Going to university is a major life event, which can be stressful and negatively affect mental health. However, it also presents an opportunity to establish a foundation for positive life trajectories. To support university students, a mobile transdiagnostic emotion regulation (ER) intervention has been developed, offering both broad-based (universal) and targeted (indicated) preventative support. ER, a transdiagnostic factor underlying various mental health problems, is a critical intervention target in students, a demographic particularly susceptible to mental health issues. Cultivating ER can help manage immediate stressors and foster long-term wellbeing. This paper describes the study protocol for a Randomized Controlled Trial (RCT) evaluating the effectiveness and uptake of such mobile transdiagnostic ER intervention. Method: The superiority parallel-group RCT involves 250 participants randomized to either the intervention condition (i.e., full access to the mobile intervention, (n = 125) or to a waitlist control condition (n = 125). Primary outcomes include ER skills and stress symptoms. Secondary outcomes include mental health parameters (anxiety, depression, resilience) and intervention uptake (i.e., objective engagement, subjective engagement, ER skills application in real life). Outcomes are assessed at baseline, week 3, 8 and 12, with continuous log-data collection for user engagement. Discussion: This study evaluates the effectiveness and uptake of a transdiagnostic ER mobile intervention for the student population addressing their ER developmental needs. If successful, the results will validate our approach to intervention development and whether focusing on learning transfer (i.e., application of the learnt skills in real-life) and personalization using a recommendation system, can boost the real-world application of skills and intervention impact.</p

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

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.</p

A Randomized Controlled Trial Comparing two Cognitive-Behavioral Programs for Adolescent Girls with Subclinical Depression: A School-Based Program (Op Volle Kracht) and a Computerized Program (SPARX)

Limited research has indicated the effectiveness of the school-based Cognitive Behavioral Therapy (CBT) prevention program ‘Op Volle Kracht (OVK)’ and the computerized CBT program ‘SPARX’ in decreasing depressive symptoms. Therefore, a randomized controlled trial of the effectiveness of OVK and SPARX was conducted among Dutch female adolescents (n = 208, mean age = 13.35) with elevated depressive symptoms. Participants were randomly assigned to one of four conditions: OVK only (n = 50), SPARX only (n = 51), OVK and SPARX combined (n = 56) and a monitoring control condition (n = 51). Participants in the first three conditions received OVK lessons and/or the SPARX game. Depressive symptoms were assessed before interventions started, weekly during the interventions, and immediately after the interventions ended, with follow-up assessments at 3, 6 and 12 months. Intention to treat results showed that depressive symptoms decreased in all conditions (F(12, 1853.03) = 14.62, p < .001), with no difference in depressive symptoms between conditions. Thus, all conditions, including the monitoring control condition, were equally effective in reducing depressive symptoms. Possible explanations for the decrease of depressive symptoms in all conditions are discussed and suggestions for future research are provided. Dutch Trial Register: NTR3737

A Game-Based School Program for Mental Health Literacy and Stigma on Depression (Moving Stories): Cluster Randomized Controlled Trial

Background: Depressive symptoms are highly prevalent among adolescents in Western countries. However, although treatment for depressive symptoms is available, many adolescents do not seek help when they need it. Important barriers to help-seeking among adolescents include low mental health literacy and high stigma. Therefore, we have developed a game-based school program, Moving Stories, which combines mental health literacy training for depression with contact with someone with lived experience both in the digital and nondigital world. Objective: The aim of this study is to conduct a first test of the effectiveness of the newly developed game-based program, Moving Stories, using a cluster randomized controlled trial. Methods: A total of 185 adolescents participated, divided over 10 classes from 4 schools. Half of the classes were randomly selected to follow the Moving Stories program, whereas the other half were in the control group, where no intervention was provided. The adolescents filled out digital questionnaires at 4 time points, with questions on mental health literacy, stigma, depressive symptoms, and the program itself (before the program, after the program, 3-month follow-up, and 6-month follow-up). Using R (R Foundation for Statistical Computing), we ran linear mixed-effects models for all continuous outcome variables and generalized linear mixed-effects models for all binary outcome variables. Results: Compared with the control group, participants in the Moving Stories group improved after the program in personal stigma (b=−0.53, 95% CI −1.02 to −0.03; t179.16=−2.08; P=.04). Effects on personal stigma lasted over time (3-month follow-up: b=−0.57, 95% CI −1.11 to −0.03; t174.39=−2.07; P=.04). Most adolescents in the Moving Stories group participated in the introduction (97/99, 98%) and contact session (93/99, 94%), played the game for 4 or 5 days (83/99, 83%), and indicated that they would recommend the game to their peers (90/98, 92%). Conclusions: The results of this study show the potential of Moving Stories as a stigma reduction program. With changes in the program to improve its effects on mental health literacy, Moving Stories could be implemented in schools to improve help-seeking in adolescents and reduce the negative consequences and burden of depressive symptoms

Adolescents’ Conformity to Their Peers’ Pro-Alcohol and Anti-Alcohol Norms: The Power of Popularity

Research on adolescent development suggests that peer influence may play a key role in explaining adolescents’ willingness to drink, an important predictor of drinking initiation. However, experiments that thoroughly examine these peer influence effects are scarce. This study experimentally examined whether adolescents adapted their willingness to drink when confronted with the pro-alcohol and anti-alcohol norms of peers in a chat room session and whether these effects were moderated by the social status of peers

An experimental study on the effects of peer drinking norms on adolescents' drinker prototypes

Adolescents form impressions about the type of peers who drink (i.e., drinker prototypes). The evaluation of, and perceived similarity to these prototypes are related to adolescents’ drinking. Peer drinking norms play an important role in the formation of prototypes. We experimentally examined whether manipulation of peer norms changed the evaluation of and perceived similarity to drinker prototypes and whether these changes were moderated by peers’ popularity

The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9–13 years of age:Results of a two-armed cluster randomized controlled trial

INTRODUCTION: Although parental support is an important component in programs designed to prevent overweight in children, current programs pay remarkably little attention to the role of parenting. We therefore developed a web-based parenting program entitled “Making a healthy deal with your child”. This e-learning program can be incorporated into existing overweight prevention programs. The aim of this study was to determine the effectiveness of this e-learning program. MATERIALS AND METHODS: The effectiveness was examined in a two-armed cluster randomized controlled trial. The participants were 475 parent-child dyads of children 9–13 years of age in the Netherlands who participated in an existing schoolclass-based overweight prevention program. At the school grade level, parents were randomly assigned to either the intervention or the control condition. Measurements were taken from both parents and children at baseline, and 5 and 12 months after baseline. Primary outcomes included the child’s dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices, and parental self-efficacy. Linear mixed effects models and generalized linear mixed effects models were conducted in R. RESULTS: Intention-to-treat analyses and completers only revealed no significant effects between the intervention and control condition on energy balance-related behaviors of the child and parenting skills after correction for multiple testing. The parents’ mean satisfaction with the e-learning program (on a 10-point scale) was 7.0±1.1. CONCLUSIONS: Although parents were generally satisfied with the parenting program, following this program had no significant beneficial effects regarding the children’s energy balance-related behaviors or the parenting skills compared to the control condition. This program may be more beneficial if used by high-risk groups (e.g. parents of children with unhealthy energy balance-related behaviors and/or with overweight) compared to the general population, warranting further study

Relative Effectiveness of CBT-Components and Sequencing in Indicated Depression Prevention for Adolescents: A Cluster-Randomized Microtrial

Objective: Cognitive Behavioral Therapy (CBT) was dismantled into four modules of three sessions each: cognitive restructuring (Think), behavioral activation (Act), problem solving (Solve) and relaxation (Relax). We investigated the modules’ relative effectiveness in indicated depression prevention for adolescents and examined variations in sequencing of these modules. Method: We performed a pragmatic cluster-randomized microtrial with four parallel conditions: (1) Think-Act-Relax-Solve (n = 14 clusters, n = 81 participants); (2) Act-Think-Relax-Solve (n = 13, n = 69); (3) Solve-Act-Think-Relax (n = 13, n = 77); and (4) Relax-Solve-Act-Think (n = 12, n = 55). The sample consisted of 282 Dutch adolescents with elevated depressive symptoms (Mage = 13.8; 55.7% girls, 92.9% Dutch). In total 52 treatment groups were randomized as a cluster. Assessments were conducted at baseline, after each module and at 6-month follow-up with depressive symptoms as primary outcome. Results: None of the modules (Think, Act, Solve, Relax) was associated with a significant decrease in depressive symptoms after three sessions and no significant differences in effectiveness were found between the modules. All sequences of modules were associated with a significant decrease in depressive symptoms at post-intervention, except the sequence Relax-Solve-Act-Think. At 6-month follow-up, all sequences showed a significant decrease in depressive symptoms. No significant differences in effectiveness were found between the sequences at post-intervention and 6-month follow-up. Conclusions: Regardless of the CBT technique provided, one module of three sessions may not be sufficient to reduce depressive symptoms. The sequence in which the CBT components cognitive restructuring, behavioral activation, problem solving and relaxation are offered, does not appear to significantly influence outcomes at post- intervention or 6-month follow-up. Abbreviations: CDI-2:F: Children’s Depression Inventory-2 Full-length version; CDI-2:S: Children’s Depression Inventory-2 Short version; STARr: Solve, Think, Act, Relax and repeat