Clinical trial NCT05746234: Emotion Regulation For All (ER4ALL) Study
Official title: A Pilot Feasibility Study for an Emotion Regulation Skills Training (ER4ALL) for Students in Higher Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotion Regulation
Keywords: Emotion regulation, Mental Health, Socio-Emotional Learning
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: University of Crete
name: Eotvos Lorand University
First posted: 2023-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a pre-post design with a multi-case study approach to evaluate the feasibility and implementation of the ER intervention in four university settings.

A mixed-methods design will be used to determine the feasibility and acceptability of the "ER4ALL" course.
Primary purpose: PREVENTION

Brief summary: In the present study, the investigators aim to examine the feasibility of a classroom-based emotion regulation skills training within a tertiary curriculum.

The primary objective of this study is to assess the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education.

The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological wellbeing.

A two-arm pilot RCT will be conducted in University of Cyprus.

Detailed description: Entering Higher Education (HE) marks a turning point for youth learning to function as independent adults, something that can be both exciting and challenging. Students are confronted with a considerable number of changes to manage (e.g. high academic expectations, making new relationships, making independent decisions), for which they may be psychosocially unfamiliar or uncomfortable.

Several studies have indeed shown that rising levels of difficulty in socio-emotional adaptation for students in HE, is linked to decreased levels of engagement and completion rates. On the other hand, the acquisition of psycho-social skills, seems to have a positive effect on students' academic achievement, resilience, employability and thriving in life.

A current challenge for HE Institutions is to ensure that during their studies, their future graduates, will have the opportunity to develop psycho-social skills, for effective management of challenges, which extend beyond academic contexts and outcomes throughout the life span in domains such as success in work, positive interpersonal relationships, and better mental health and overall well-being.

Further examination of the potential impact of integrating empirically supported transversal components that derive from empirical research (e.g. emotion regulation skills), is needed. In addition to that, since the focus is on a university-wide student population, it would be useful to further investigate whether the standard mode of delivery (in which learning capacity, language ability, and executive functions are considered essential ingredients for program success), fits well to student population with diverse learning styles, academic performance or learning abilities, such as language skills (listening, reading, speaking and writing), executive skills (e.g. sustain attention) or cognitive processes such as memory and abstract thinking. A growing literature pinpoints to the potential of incorporating art-based methodologies, such as music which is characterized by personalized methods and has shown promising effects on its effectiveness for inclusive educational practices. Music is a promising means that can afford opportunities for learning not afforded by other modalities. Collectively, music holds the potential to address life-long needs for young adults, by infusing culturally appropriate practices that can be easily integrated into the young adults' everyday experiences at the level of their abilities. Music interventions have been linked to improvements in mental and physical capacities in various settings and populations. Research findings additionally support that music can be used as a tool for emotion regulation by reducing stress and stimulate cognitive processes such as attention, learning and memory. Taking into account the above, it is of great interest to develop and investigate how different modalities, such as music-based methodologies, can alter the effectiveness of existing empirically supported approaches, such as emotion regulation skills training.

The primary objective of this study is to gain insight into the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education. The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological functioning.

The specific objectives of the study are to:

1. Determine feasibility and acceptability of the "ER4ALL" course.

   1. To estimate feasible recruitment and refusal rates.
   2. To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction (both qualitative and quantitative).
   3. To determine the acceptability of course resources and factors influencing this (e.g. diverse learning styles or abilities).
2. Compare the effectiveness between two "ER4ALL" modalities: standard language-based mode Vs. music-based mode.

   1. To explore preliminary differences on acceptability.
   2. To explore preliminary differences on associated changes in acquired knowledge and psychological functioning.

Eligibility criteria: Inclusion Criteria - People who are enrolled as students in the university

Exclusion criteria

- No specific exclusion criteria.

Primary outcomes:
measure: Feasibility of the course
timeFrame: up to 10 weeks
measure: Acceptability of the course
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Emotion Beliefs Questionnaire
timeFrame: up to 10 weeks
measure: Acceptance and Action Questionnaire-II
timeFrame: up to 10 weeks
measure: Psyflex
timeFrame: up to 10 weeks
measure: Positive Mental Health Scale (PMH-scale)
timeFrame: up to 10 weeks
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: up to 10 weeks
measure: Brief Multidimensional Students' Life Satisfaction Scale-College (BMSLSS-C)
timeFrame: up to 10 weeks
measure: University Student Learning Disabilities Questionnaire
timeFrame: up to 10 weeks
Other outcomes:
measure: Participants characteristics
timeFrame: up to 10 weeks
measure: Fidelity
timeFrame: up to 10 weeks
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
Study officials:
References: