Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students

NCT ID: NCT05576883

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2023-06-13

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.

Conditions

Emotion Regulation; Stress; Depressive Symptoms; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Emotion Regulation Intervention and Control Intervention

Participants will be asked in the morning and in the evening at their self-selected time to evaluate their emotional state through ecological momentary assessment (EMA) and will be prompted to engage in an ER intervention (60% likelihood) or to read health information (40% likelihood). Upon completion they will evaluate the likability and helpfulness of the exercise or the article and re-evaluate their emotional state (post-EMA).

The intervention consists of 20 ER exercises and 20 health facts. The ER intervention is based on different therapeutic approaches targeting various underlying transdiagnostic factors such as rumination, self-referential thoughts etc. The 20 health facts will act as a placebo intervention with no effect on emotion regulation and keep participants engaged in the post-EMA evaluation when they are not randomized to an exercise.

The interventions and the control intervention materials were developed by the research team for the purposes of this study.

Group Type: OTHER

Transdiagnostic emotion regulation intervention

Intervention Type: BEHAVIORAL

The intervention under study includes 5 therapeutic approaches, namely: Positive psychology [PP], Mindfulness, Acceptance and Commitment Therapy [ACT], Breathing and relaxation, and Self-compassion [SC].

The intervention consists of 4 core features:

(i) monitoring through filling in EMAs assessing participants emotional states

(ii) feedback through visualization of participant emotional states upon every completion of the EMAs

(iii) exercises targeting different emotion regulation skills [i.e., upregulation of positive affect, mindfulness, cognitive defusion, breathing and relaxation, self-compassion) and health facts (i.e., control intervention) describing health information including nutrition, exercise, sleeping habits.

(iv) psychoeducative articles describing the 5 therapeutic approaches (PP, ACT, Mindfulness, Breathing and Relaxation, SC)

Interventions

Transdiagnostic emotion regulation intervention

The intervention under study includes 5 therapeutic approaches, namely: Positive psychology [PP], Mindfulness, Acceptance and Commitment Therapy [ACT], Breathing and relaxation, and Self-compassion [SC].

The intervention consists of 4 core features:

(i) monitoring through filling in EMAs assessing participants emotional states

(ii) feedback through visualization of participant emotional states upon every completion of the EMAs

(iii) exercises targeting different emotion regulation skills [i.e., upregulation of positive affect, mindfulness, cognitive defusion, breathing and relaxation, self-compassion) and health facts (i.e., control intervention) describing health information including nutrition, exercise, sleeping habits.

(iv) psychoeducative articles describing the 5 therapeutic approaches (PP, ACT, Mindfulness, Breathing and Relaxation, SC)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus University Rotterdam

OTHER

Sponsor Role: lead

Responsible Party

Marilisa Boffo

Assistant Professor in Clinical Psychology and eHealth,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Rotterdam

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 37889525 (View on PubMed)

Related Links

http://psyarxiv.com/xgq2r/

Study Pre-print

Other Identifiers

ETH2122-0677

Identifier Type: -

Identifier Source: org_study_id