- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06224647
Evaluation of a Transdiagnostic Mobile App Intervention Among University Students
Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tajda Laure, Msc
- Phone Number: (+31)638436367
- Email: laure@essb.eur.nl
Study Contact Backup
- Name: Marilisa Boffo, PhD
- Email: boffo@essb.eur.nl
Study Locations
-
-
South Holland
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Rotterdam, South Holland, Netherlands, 3062 PA
- Recruiting
- Erasmus University Rotterdam
-
Contact:
- Marilisa Boffo, PhD
- Phone Number: 0642839480
- Email: boffo@essb.eur.nl
-
Contact:
- Tajda Laure, Msc
- Phone Number: 0638436367
- Email: laure@essb.eur.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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:
Other Names:
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and days 21, 56, and 84.
|
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.
|
At baseline, and days 56 and 84.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 1-84
|
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? |
Day 21, 56, 84
|
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.
|
At baseline and day 84
|
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.
|
At baseline and day 84
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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.
|
At baseline and day 84
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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.
|
Day 1 - 84
|
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.
|
Day 1-84
|
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)
|
Day 56
|
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? |
Day 56
|
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)
|
Day 56
|
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.
|
Day 56
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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).
|
Day 56
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETH2324-0193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data [and code] produced in the project will be shared in a research data repository [EUR Data Repository (EDR) and Open Science Framework (OSF)]. A DCMI (Dublin Core Metadata Initiative) standard will be used to document this research. There will be a temporary restriction on re-using of the data (Embargo period of 6 months).
Data (and code) that will be shared in a research data repository are: Anonymized survey data, Codebook and Blank Questionnaires, Readme text file (general description of the data, including date of collection, selection procedure of participants, tools used to collect the data etc.), and scripts of data analysis.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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