Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students

NCT05576883 | Completed

• 1 other identifier: ETH2122-0677
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Stress; Depressive Symptoms; Anxiety

Keywords

Transdiagnostic intervention; Micro Randomized Trials; User research; Mental health; University Students

Outcome Measures

Primary Outcomes (6)

• Changes in a momentary emotional state

  Participants will be asked to evaluate seven emotional states before and after engaging in the ER intervention or control intervention by answering the question: "How \[affect (e.g., happy)\] do you feel at the moment?" Each of 7 emotional states is evaluated on a scale from 1 \[Not at all\] to 5 \[Extremely\]. The emotional states are combined into 2 categories of affect: negative (stressed, frustrated, sad, fatigued) and positive (happy, energetic, relaxed). Changes in the momentary emotional states (i.e., positive and negative affect) will be evaluated by looking at the responses on the pre and post EMA in the relation to whether a participant received an ER intervention or health information.

  Day 2 - day 22

• Changes in thought believability and discomfort after engaging in CD exercise

  When randomized to CD exercise, participants will be asked to evaluate their self-selected unhelpful thought answering the following questions on a scale from 1 (not at all uncomfortable/believable) to 100 (extremely uncomfortable / believable) before and after the exercise: "How uncomfortable is the thought?" "How believable (true) is the thought?" The effects of CD exercises will be assessed by comparing the pre and post scores on the two thought parameters.

  Day 2 - day 22

• Objective engagement patterns: Engagement metrics

  Objective engagement patterns with the intervention will be assessed using descriptive statistics of engagement metrics (i.e., exercise completion rates, average time spent, and times of the day where participants completed the exercises) per exercise and exercise category. In addition, a correlational analysis will be used to evaluate whether there is a relationship between time of the day and exercise completion rates.

  Day 2 - day 22

• Objective engagement patterns: Relationship between time of the day and exercise completion

  A correlational analysis will be used to evaluate whether there is a relationship between the time of the day participants engaged in an exercise and exercise completion rates.

  Day 2 - day 22

• Subjective engagement patterns: Exercise likeability and helpfulness

  Subjective engagement patterns will be evaluated by combining exercise likeability and helpfulness ratings with information from the semi-structured interviews. Exercise likeability and helpfulness are assessed with items rated on a scale from 1 (not at all) to 5 (very much): "How much did you like the exercise?" "How helpful did you find the exercise?"

  Day 2 - day 22

• Subjective engagement patterns: User experience

  Semi-structured interviews will be conducted with a subsample of participants (n=21) within three weeks upon completion of the MRT. University students will be asked to report on their general experience with intervention as well as intervention categories and separate exercises. Example questions are: "What do you think about the intervention?", "What kind of difficulties did you experience while using it?",

  Up to 3 weeks upon completion of the Micro Randomized Trial

Secondary Outcomes (4)

• Changes in ER skills

  At the baseline and day 23

• Changes in Anxiety symptoms

  At the baseline and day 23

• Changes in Depressive symptoms

  At the baseline and day 23

• Changes in stress levels

  At the baseline and day 23

Study Arms (1)

Emotion Regulation Intervention and Control Intervention

OTHER

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.

Behavioral: Transdiagnostic emotion regulation intervention

Interventions

Transdiagnostic emotion regulation intervention 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)

Emotion Regulation Intervention and Control Intervention

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Related Links

• Study Pre-print

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Clinical Psychology and eHealth,

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 13, 2022
• Study Start: February 10, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

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)