Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

E

Erasmus University Rotterdam

Status

Enrolling

Conditions

Depressive Symptoms
Resilience
Emotion Regulation
Anxiety
Stress

Treatments

Behavioral: Mobile Transdiagnostic Emotion Regulation Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06224647
ETH2324-0193

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 32 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

250 participants in 2 patient groups

Access to the intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Mobile Transdiagnostic Emotion Regulation Intervention
Waitlist control condition
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Marilisa Boffo, PhD; Tajda Laure, Msc

Data sourced from clinicaltrials.gov

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