Clinical trial NCT05576883: Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students
Official title: Optimizing a Mobile Transdiagnostic Emotion Regulation Intervention for University Students: A Micro Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Stress
Depressive Symptoms
Anxiety
Keywords: Transdiagnostic intervention
Micro Randomized Trials
User research
Mental health
University Students
Lead sponsor: Erasmus University Rotterdam
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study utilizes a Micro Randomized Trial \[MRT\] method to evaluate the effects of the intervention. Compared to a multi-arm trial, in which participants are randomized to an intervention or control group, in an MRT individuals are randomized repeatedly to different interventions during the trial which allows for a large number of observations of the targeted proximal outcome(s) per participant (in this case, emotional states). This design also allows us to investigate contextual moderators of proximal effects such as time of intervention delivery and emotional state.
Primary purpose: PREVENTION

Brief summary: This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.

Detailed description: It is estimated that globally between 12 and 50% of all university students are affected by mental health problems, the most common ones being anxiety, depression, and substance abuse. Over the past years online-based interventions have been spotlighted by researchers and clinicians as an avenue for a better outreach and provision of low threshold interventions aimed at primary and secondary prevention of mental health problems among the university students population.

As part of a student wellbeing program at the Erasmus University Rotterdam (EUR), a transdiagnostic mobile intervention consisting of a suite of preventative self-guided tools is being developed. Its' goal is to help students better manage their mental health by teaching them adaptive emotional regulation strategies.

The intervention includes exercises from different therapeutic approaches, and targets transdiagnostic factors such as negative self-referential thoughts, rumination, experiences of prolonged negative emotional states, and mental health literacy. The intervention is delivered via a smartphone and consists of 20 therapeutic exercises teaching students strategies like upregulation of positive affect, staying present in the moment, cognitive defusion, relaxation and breathing techniques, and self compassion skills.

The main goals of the study are to evaluate whether the intervention and its components have the intended effects on student's emotional states as well as get insight into students' engagement patterns and experience with the intervention. This will be done by utilizing an explanatory sequential mixed methods approach combining novel methods of online-intervention assessment, specifically Micro Randomized Trials (MRT) with semi-structured interviews, which will provide information on the lived experiences of the participants with the intervention and provide explanation of the quantitative results. The results of this trial will support the optimization and further development of the mobile application that will later be evaluated for its full-scale effectiveness.

Eligibility criteria: Inclusion Criteria:

* Willing to provide informed consent
* Currently enrolled as a student at the Erasmus University Rotterdam
* Own a smartphone with an active phone number
* Feel comfortable speaking and writing in the English language
* Having a score between 5 (mild) and 19 (moderately severe) on the PHQ-9

Exclusion Criteria:

Participants are not eligible for this study if they:

* Experience significant suicidal thoughts over the past month
* Have a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
* Are undergoing psychopharmacological treatment or treatment with experimental drugs

Primary outcomes:
measure: Changes in a momentary emotional state
timeFrame: Day 2 - day 22
measure: Changes in thought believability and discomfort after engaging in CD exercise
timeFrame: Day 2 - day 22
measure: Objective engagement patterns: Engagement metrics
timeFrame: Day 2 - day 22
measure: Objective engagement patterns: Relationship between time of the day and exercise completion
timeFrame: Day 2 - day 22
measure: Subjective engagement patterns: Exercise likeability and helpfulness
timeFrame: Day 2 - day 22
measure: Subjective engagement patterns: User experience
timeFrame: Up to 3 weeks upon completion of the Micro Randomized Trial
Secondary outcomes:
measure: Changes in ER skills
timeFrame: At the baseline and day 23
measure: Changes in Anxiety symptoms
timeFrame: At the baseline and day 23
measure: Changes in Depressive symptoms
timeFrame: At the baseline and day 23
measure: Changes in stress levels
timeFrame: At the baseline and day 23
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.