NCT06224647

Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Erasmus University Rotterdam · Academic / Other
• Sex: All
• Age: 18 Years – 32 Years
• Healthy volunteers: Accepted

Summary

This study is a two-armed randomized controlled trial (RCT) aimed at evaluating the effectiveness and adoption of a transdiagnostic mobile app intervention that focuses is on enhancing adaptive emotional regulation (ER) skills among university students.

Detailed description

Globally, an estimated 30% of university students struggle with mental health issues, primarily anxiety, depression, and substance abuse. Recent trends have highlighted the potential of online interventions for accessible, low-threshold support in preventing these issues among this demographic. At Erasmus University Rotterdam (EUR), a transdiagnostic mobile app is being developed as part of a student wellbeing program. This app provides a range of tools aimed at improving mental health by teaching students adaptive emotional regulation strategies. It incorporates exercises from various therapeutic modalities, addressing factors like negative thoughts, rumination, and prolonged negative emotions. Delivered through a smartphone, the app includes 24 therapeutic exercises focusing on techniques such as enhancing positive emotions, mindfulness, cognitive defusion, cognitive restructuring, relaxation, breathing, and self-compassion. The present study is a 12-week two-armed RCT study with outcomes assessed at the baseline, and three follow-ups at weeks 3, 8, and 12. It compares a group of distressed students with access to the mobile app intervention against a waitlist control group. The main goal of the study is to assess the impact of the intervention on stress symptoms and emotional regulation skills. The secondary outcomes of the study, include an evaluation of the intervention's impact on depression, anxiety symptoms, and students' resilience levels. Lastly, the study examines the app's uptake, including engagement patterns and user experiences, and evaluates the real-life application of the skills learned through the app.

Conditions

• Emotion Regulation
• Stress
• Resilience
• Depressive Symptoms
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Mobile Transdiagnostic Emotion Regulation Intervention	The intervention aims to provide a tailored and engaging way for users to manage and comprehend their emotional well-being. It consist of 5 components: 1. Daily tracking of emotions 2. A suite of exercises placed in six categories facilitating adaptive emotion regulation skills (i.e., upregulation of positive effect, self-compassion, cognitive defusion and cognitive restructuring, mindfulness, breathing techniques), 3. A self-assessment module where users can complete surveys evaluating their states (e.g., wellbeing) and traits (e.g., perfectionistic tendencies), 4. A personal toolkit area (i.e., each exercise is represented by an object commonly found in a student's room. Users can collect objects of favoured exercises in the virtual ROOM, enabling them quick access to exercises they liked / found helpful), 5. A recommendation system linking users to the content based on their specific needs or preferences

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2024-01-25
• Last updated: 2024-08-28

Locations

1 site across 1 country: Netherlands