Emotion RegulationNCT06224647
Evaluation of a Transdiagnostic Mobile App Intervention Among University Students
A study testing Mobile Transdiagnostic Emotion Regulation Intervention in people with Emotion Regulation and Stress, run by Erasmus University Rotterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Stress, Resilience
- What is being tested?
- Mobile Transdiagnostic Emotion Regulation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Rotterdam
Rotterdam, South Holland, 3062 PA
About this study
Official title: Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Mobile Transdiagnostic Emotion Regulation Intervention
- Keywords
- Transdiagnostic intervention, Digital intervention, Mental health, University Students, Randomized Controlled Trial
- Medical subject headings
- Emotional Regulation, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Transdiagnostic Emotion Regulation InterventionBehavioural
Also called ROOM app
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:
- Daily tracking of emotions
- 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),
- A self-assessment module where users can complete surveys evaluating their states (e.g., wellbeing) and traits (e.g., perfectionistic tendencies),
- 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),
- A recommendation system linking users to the content based on their specific needs or preferences
| Study group | Role | What they receive |
|---|---|---|
| Access to the intervention | Experimental | 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. Receives: Behavioral: Mobile Transdiagnostic Emotion Regulation Intervention |
| Waitlist control condition | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in stress symptoms
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.
Measured: At baseline and days 21, 56, and 84.
Changes in ER skills
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.
Measured: At baseline, and days 56 and 84.
Secondary outcomes (12)
Changes in depressive symptoms
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.
Measured: At baseline and day 84
Changes in anxiety symptoms
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.
Measured: At baseline and day 84
Changes in resilience levels
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.
Measured: At baseline and day 84
Objective engagement patterns
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.
Measured: Day 1 - 84
Subjective engagement: Exercise likeability and helpfulness
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?
Measured: Day 1-84
Subjective engagement: Likeability and helpfulness of Self-assessment component
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?
Measured: Day 56
Subjective engagement: Likeabilty of Virtual Collectibles Room
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?
Measured: Day 56
Subjective engagement: Usefulness and perceived effectiveness of recommendation system
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?
Measured: Day 56
Subjective engagement: User experience with the app
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.
Measured: Day 56
Engagement with the exercises outside of the app: In app counter
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.
Measured: Day 1-84
Engagement with ER techniques outside of the app
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?
Measured: Day 21, 56, 84
Likability and helpfulness of transfer strategies offered in the app
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?
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start5 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus University Rotterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilisa Boffo, Erasmus University Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224647
- Sponsor's protocol ID
- ETH2324-0193
- Status last verified
- Aug 2024
- First submitted
- 16 Jan 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37889525
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Uptake of a Transdiagnostic Emotion Regulation Mobile Intervention Among University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06224647
- Acronym / sponsor ID
- ETH2324-0193
- Conditions
- Emotion Regulation, Stress, Resilience, Depressive Symptoms, Anxiety
- Keywords
- Transdiagnostic intervention, Digital intervention, Mental health, University Students, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Erasmus University RotterdamUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Access to the intervention | Experimental | Behavioral: Mobile Transdiagnostic Emotion Regulation InterventionParticipants 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. |
| Waitlist control condition | No intervention | –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. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Transdiagnostic Emotion Regulation InterventionAlso: ROOM appThe 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 | Behavioural | Access to the intervention |
Primary outcome
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.
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.
12 secondary outcomes
Changes in depressive symptoms
Time frame: At baseline and day 84
Changes in anxiety symptoms
Time frame: At baseline and day 84
Changes in resilience levels
Time frame: At baseline and day 84
Objective engagement patterns
Time frame: Day 1 - 84
Subjective engagement: Exercise likeability and helpfulness
Time frame: Day 1-84
Subjective engagement: Likeability and helpfulness of Self-assessment component
Time frame: Day 56
Subjective engagement: Likeabilty of Virtual Collectibles Room
Time frame: Day 56
Subjective engagement: Usefulness and perceived effectiveness of recommendation system
Time frame: Day 56
Subjective engagement: User experience with the app
Time frame: Day 56
Engagement with the exercises outside of the app: In app counter
Time frame: Day 1-84
Engagement with ER techniques outside of the app
Time frame: Day 21, 56, 84
Likability and helpfulness of transfer strategies offered in the app
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 37889525Laure 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Transdiagnostic Emotion Regulation Intervention in people with Emotion Regulation and Stress, run by Erasmus University Rotterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stress symptoms (time frame: At baseline and days 21, 56, and 84.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.