Clinical trial NCT06224647: Evaluation of a Transdiagnostic Mobile App Intervention Among University Students
Official title: Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Stress
Resilience
Depressive Symptoms
Anxiety
Keywords: Transdiagnostic intervention
Digital intervention
Mental health
University Students
Randomized Controlled Trial
Lead sponsor: Erasmus University Rotterdam
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a 12-week superiority parallel-group randomized controlled trial including three follow-up assessments at weeks 3, 8, and 12. Eligible participants are randomized to either an intervention condition (i.e., full access to the app) or to the waitlist control condition (i.e., receives access upon completion of the study).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in stress symptoms
timeFrame: At baseline and days 21, 56, and 84.
measure: Changes in ER skills
timeFrame: At baseline, and days 56 and 84.
Secondary outcomes:
measure: Changes in depressive symptoms
timeFrame: At baseline and day 84
measure: Changes in anxiety symptoms
timeFrame: At baseline and day 84
measure: Changes in resilience levels
timeFrame: At baseline and day 84
measure: Objective engagement patterns
timeFrame: Day 1 - 84
measure: Subjective engagement: Exercise likeability and helpfulness
timeFrame: Day 1-84
measure: Subjective engagement: Likeability and helpfulness of Self-assessment component
timeFrame: Day 56
measure: Subjective engagement: Likeabilty of Virtual Collectibles Room
timeFrame: Day 56
measure: Subjective engagement: Usefulness and perceived effectiveness of recommendation system
timeFrame: Day 56
measure: Subjective engagement: User experience with the app
timeFrame: Day 56
measure: Engagement with the exercises outside of the app: In app counter
timeFrame: Day 1-84
measure: Engagement with ER techniques outside of the app
timeFrame: Day 21, 56, 84
measure: Likability and helpfulness of transfer strategies offered in the app
timeFrame: Day 56
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Rotterdam
state: South Holland
Study officials:
References:
citation: 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.