Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

NCT ID: NCT06224647

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-07-01

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.

Conditions

Emotion Regulation; Stress; Resilience; Depressive Symptoms; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Access to the 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.

Group Type: EXPERIMENTAL

Mobile Transdiagnostic Emotion Regulation Intervention

Intervention Type: 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:

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

Waitlist control condition

Participants allocated to the control group will be put on a waitlist and granted access to the mobile intervention after the trial concludes. They will then receive the same intervention with the identical onboarding process as the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

ROOM app

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus University Rotterdam

OTHER

Sponsor Role: lead

Responsible Party

Marilisa Boffo

Assistant professor of Clinical Psychology and eHealth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Rotterdam

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

Laure T, Engels RCME, Remmerswaal D, Spruijt-Metz D, Konigorski S, Boffo M. Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603.

Reference Type: BACKGROUND

PMID: 37889525 (View on PubMed)

Other Identifiers

ETH2324-0193

Identifier Type: -

Identifier Source: org_study_id