Evaluation of a Transdiagnostic Mobile App Intervention Among University Students

NCT06224647 | Completed

• 1 other identifier: ETH2324-0193
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Stress; Resilience; Depressive Symptoms; Anxiety

Keywords

Transdiagnostic intervention; Digital intervention; Mental health; University Students; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline, and days 56 and 84.

Secondary Outcomes (12)

• Changes in depressive symptoms

  At baseline and day 84

• Changes in anxiety symptoms

  At baseline and day 84

• Changes in resilience levels

  At baseline and day 84

• Objective engagement patterns

  Day 1 - 84

• Subjective engagement: Exercise likeability and helpfulness

  Day 1-84

Study Arms (2)

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.

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.

Interventions

Mobile Transdiagnostic Emotion Regulation Intervention 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

Also known as: ROOM app

Access to the intervention

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus University Rotterdam: lead

Study Sites (1)

Erasmus University Rotterdam

Rotterdam, South Holland, 3062 PA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37889525 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation; Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator conducting the analyses will be blinded to group assignments, remaining unaware of which data corresponds to the control group and which to the intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Clinical Psychology and eHealth

Model Details: 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).

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: February 5, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will come available after the embargo period of 6 months

Locations

NL (1)