Erasmus University Rotterdam
Rotterdam, South Holland, 3062 PA, Netherlands
NCT Number: NCT06224647
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.
Looking for future studies?
Notify Me18 year–32 year
All sexes
Interventional
Not applicable
Rotterdam, South Holland, 3062 PA, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Other names: ROOM app
Time frame: At baseline and days 21, 56, and 84.
Perceived Stress Scale (PSS-10) is used to evaluate participants' stress levels. Participants are asked to specify how often they felt or thought a certain way over the last month on a scale from 0 [never] to 5 [very often]. The score ranges from 0 - 40, with higher scores indicating higher levels of perceived stress symptoms.
Time frame: At baseline, and days 56 and 84.
The Emotion Regulation Skills Questionnaire (ERSQ) will be used to assess emotion regulation skills. This instrument includes seven distinct emotion regulation skills: awareness, sensation, clarity, understanding, acceptance, tolerance, compassionate self-support, confrontation readiness, and modification of negative emotions. It consists of 27 items, each scored on a scale ranging from 0 (not at all) to 4 (almost always). Higher scores on both the ERSQ subscales and the aggregate ERSQ score are indicative of higher emotion regulation skills.
Time frame: At baseline and day 84
Depressive symptoms are measured with the Patient Health Questionnaire (PHQ-9). Participants are asked to indicate how often they have been bothered by a certain symptom over the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). PHQ-9 scores range from 0-27. Higher scores indicate higher levels of depressive symptoms.
Time frame: At baseline and day 84
Anxiety symptoms are measured with the Generalized Anxiety Disorder (GAD-7) questionnaire. Participants are asked to indicate how often they have been bothered by a certain symptom over the last two weeks on a scale from 0 (not at all) to 3 (nearly every day). The scores on GAD-7 range between 0-21, with higher scores indicating higher levels of anxiety.
Time frame: At baseline and day 84
Resilience levels are evaluated with the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Items are scored on a scale ranging from 0 (not true at all) to 4 (true nearly all the time). Total scores range between 0 and 40 with higher scores indicating greater resilience.
Time frame: Day 1 - 84
Objective engagement patterns include exercise completion and non-completion (i.e., exercise started but not finished) rates, average time spent on each exercise, engagement in self-assessment module (i.e., number of questionnaires and Ecological Momentary Assessments completed), the number of objects collected in the "virtual room", the number of times the app was accessed. Log data is used to evaluate objective engagement patterns.
Time frame: Day 1-84
Exercise likeability and helpfulness is evaluated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much) every time a participant completes an exercise.
Time frame: Day 56
The likeability and helpfulness of the Self-assessment module (MapMyself) is evaluated on a scale from 1 (not at all) to 5 (very much)
Time frame: Day 56
The likeability of the Virtual Collectibles Room component is assessed on a scale ranging from 1 (not at all) to 5 (very much)
Time frame: Day 56
Participants are asked to evaluate the recommendation system by rating the following two questions on a scale from 1 (not at all) to 5 (very much)
Time frame: Day 56
User experiences are evaluated with a User Experience Questionnaire (UEQ) measuring the Attractiveness, Perspicuity, Efficiency, Dependability, and Novelty of the app. The questionnaire includes 26 items measured on a semantic differential (e.g., attractive - unattractive). The items are scored from -3 (the most negative answer) to +3 (the most positive answer), with 0 representing a neutral answer.
Time frame: Day 1-84
The mobile intervention includes a feature (i.e., an exercise counter) where users can log in the number of times they completed an exercise outside of the app.
This counter is used to evaluate the number of exercises performed independently from the app.
Time frame: Day 21, 56, 84
Participants are asked to evaluate how often they applied ER techniques (e.g., self-compassion, breathing pattern, savouring, being mindful, reframing unhelpful thoughts) in their daily life over the past month on a scale from 0 (not at all) - 4 (daily).
Time frame: Day 56
For evaluation of the learning transfer features in the app, participant will be asked to rate the following questions on a scale from (0 - Not at all; 100 - Very much or So far I haven't used this feature).
Erasmus University Rotterdam
Other
Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05576883
Anxiety, Anxiety Disorders
Rotterdam, South Holland, Netherlands
View Trial DetailsNCT06147297
Anxiety, Anxiety Disorders
Hong Kong
View Trial DetailsNCT06154369
Anxiety, Anxiety Disorders
Thunder Bay, Ontario, Canada
View Trial DetailsNCT05227794
Anxiety, Anxiety Disorders
New Haven, Connecticut, United States
View Trial Details