Skip to main content
OpenTrials
Completed

NCT Number: NCT06224647

Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus University Rotterdam

Rotterdam, South Holland, 3062 PA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate and provide informed consent
  • Access to smartphone and internet
  • Feels comfortable with English language for verbal and written communication and interaction with the app
  • Scores <13 on the Perceived Stress Scale (PSS-10)

Exclusion criteria

  • Scores >20 on the Patient Health Questionnaire (PHQ-9)
  • Having a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
  • Undergoing psychopharmacological treatment or treatment with experimental drugs

Treatment and study plan

Mobile Transdiagnostic Emotion Regulation Intervention

Behavioral

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:

  • Daily tracking of emotions
  • 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),
  • A self-assessment module where users can complete surveys evaluating their states (e.g., wellbeing) and traits (e.g., perfectionistic tendencies),
  • 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),
  • A recommendation system linking users to the content based on their specific needs or preferences

Other names: ROOM app

Primary outcomes

  1. Changes in stress symptoms

    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.

  2. Changes in ER skills

    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.

Secondary outcomes

  1. Changes in depressive symptoms

    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.

  2. Changes in anxiety 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.

  3. Changes in resilience levels

    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.

  4. Objective engagement patterns

    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.

  5. Subjective engagement: Exercise likeability and helpfulness

    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.

    • How much did you like the exercise?
    • How helpful did you find the exercise?
  6. Subjective engagement: Likeability and helpfulness of Self-assessment component

    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)

    • How much did you like the self-assessment (MapMyself) feature in the app?
    • How helpful did you find the self-assessment (MapMyself) feature in the app?
  7. Subjective engagement: Likeabilty of Virtual Collectibles Room

    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)

    • How much do you like collecting objects in the ROOM app?
  8. Subjective engagement: Usefulness and perceived effectiveness of recommendation system

    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)

    • How useful do you find the in-app recommendations of the exercises?
    • How well do the in-app recommendations of exercises align with your self-reported moods?
  9. Subjective engagement: User experience with the app

    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.

  10. Engagement with the exercises outside of the app: In app counter

    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.

  11. Engagement with ER techniques outside of 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).

    • Over the past month, how frequently have you spontaneously used any of the techniques you've learned in ROOM app either to manage your emotions during challenging times or to improve your overall mood?
  12. Likability and helpfulness of transfer strategies offered in the app

    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).

    • How much do you like action planning with 'when-then' statements?
    • How helpful do you find the action planning with 'when-then' statements?
    • How much do you like to use stickers to create cues to practice the techniques?
    • How helpful do you find stickers to create cues to practice the techniques?
    • How much do you like the 'practice semi-guided' feature of the app?
    • How helpful do you find the 'practice semi-guided' feature of the app?

Sponsors and collaborators

Lead sponsor

Erasmus University Rotterdam

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Aug 28, 2024

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.