Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

Not Applicable

Completed

• Conditions: Emotion Regulation; Stress; Resilience; Depressive Symptoms; Anxiety
• Interventions: Behavioral: Mobile Transdiagnostic Emotion Regulation Intervention

• Registration Number: NCT06224647
• Lead Sponsor: Erasmus University Rotterdam

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Study Start: 2024-02-05
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Access to the intervention	Mobile Transdiagnostic Emotion Regulation Intervention	Participants assigned to the intervention group will have full access to the mobile app intervention, namely ROOM app, for the whole duration of the 12-week trial. As part of the app's onboarding process, participants will receive tips on optimal app usage and can decide to take part in a 21-day challenge where they are encouraged to assess their emotional states on a daily basis and complete one exercise per day. During the onboarding process, participants are encouraged to explore different emotional regulation exercises offered in the app and to save the ones they find most beneficial in their "virtual Room", curating a personalized well-being toolkit. While daily notifications prompt regular app engagement, no additional efforts are made to further promote its use.

Primary Outcome Measures

Name	Time	Method
Changes in stress symptoms	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.
Changes in ER skills	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 Outcome Measures

Name	Time	Method
Engagement with ER techniques outside of the app	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?
Likability and helpfulness of transfer strategies offered in the app	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?
Changes in depressive symptoms	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.
Subjective engagement: Likeability and helpfulness of Self-assessment component	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?
Subjective engagement: Likeabilty of Virtual Collectibles Room	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?
Subjective engagement: User experience with the app	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.
Objective engagement patterns	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.
Subjective engagement: Exercise likeability and helpfulness	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?
Subjective engagement: Usefulness and perceived effectiveness of recommendation system	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?
Engagement with the exercises outside of the app: In app counter	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.
Changes in anxiety symptoms	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.
Changes in resilience levels	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.

Trial Locations

Locations (1)

Erasmus University Rotterdam; 🇳🇱 Rotterdam, South Holland, Netherlands