Emotion Regulation For All (ER4ALL) Study

NCT ID: NCT05746234

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-02-28

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.

Conditions

Emotion Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Music-Based ER module

The program will involve the following modules: a) VALUES & SETTING GOALS FOR ENHANCING MOTIVATION, b) MODULE 2. UNDERSTANDING EMOTIONS, c) MODULE 3. MINDFUL EMOTION AWARENESS AND RELAXATION, d) MODULE 4. THINKING FLEXIBLY, e) MODULE 5. COUNTERING INAPPROPRIATE BEHAVIORS.

The rationale of the training was built based on the framework of Unified Protocol (Barlow, et al. 2018) and training activities were selected and adapted from a compilation of foundational works on contemporary evidence-based approaches, (i.e. Cognitive Behavioral approach, Acceptance and Commitment approach, and Dialectical Behavior approach). Activities were adapted using core components of music-based interventions (Dingle & Fay, 2016; McFerran, 2016; Saarikallio, 2019) with emphasis on emotion recognition in music, regulation of stress and negative emotions through active music listening, and self-reflective awareness of emotional responses to music.

Group Type: EXPERIMENTAL

Emotion Regulation Course

Intervention Type: BEHAVIORAL

Each module contains a) the session outline, b) review of previous session's homework, c) theoretical background and module's rationale, d) skills activities, and e) homework assignment.

Each group will attend five 1.5-hour sessions with their allocated instructor. Participants in both groups will receive the same training modules in the same chronological order. For consistency across modalities, participants will receive an instructor's manual containing the core material for facilitating the ER4ALL training, and a companion students' workbook with supporting information and activities.

Standard ER module

Participants will receive the same training modules in the same chronological order as the music-based group. The only difference is that modules will be mainly text/language based (instead of using music methodologies).

Group Type: ACTIVE_COMPARATOR

Emotion Regulation Course

Intervention Type: BEHAVIORAL

Each module contains a) the session outline, b) review of previous session's homework, c) theoretical background and module's rationale, d) skills activities, and e) homework assignment.

Each group will attend five 1.5-hour sessions with their allocated instructor. Participants in both groups will receive the same training modules in the same chronological order. For consistency across modalities, participants will receive an instructor's manual containing the core material for facilitating the ER4ALL training, and a companion students' workbook with supporting information and activities.

Interventions

Emotion Regulation Course

Each module contains a) the session outline, b) review of previous session's homework, c) theoretical background and module's rationale, d) skills activities, and e) homework assignment.

Each group will attend five 1.5-hour sessions with their allocated instructor. Participants in both groups will receive the same training modules in the same chronological order. For consistency across modalities, participants will receive an instructor's manual containing the core material for facilitating the ER4ALL training, and a companion students' workbook with supporting information and activities.

Intervention Type: BEHAVIORAL

Other Intervention Names

ER4ALL course

Eligibility Criteria

Inclusion Criteria

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

Exclusion criteria

• No specific exclusion criteria.

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

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

University of Crete

OTHER

Sponsor Role: collaborator

Eotvos Lorand University

OTHER

Sponsor Role: collaborator

University of Cyprus

OTHER

Sponsor Role: lead

Responsible Party

Prof. Georgia Panayiotou

Dr. Georgia Panayiotou, Professor of Clinical Psychology, Department of Psychology and Center for Applied Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cyprus

Nicosia, , Cyprus

Site Status: RECRUITING

Countries

Cyprus

Facility Contacts

Marios o Theodorou, PhD

Role: primary

theodorou.marios@ucy.ac.cy

+35722892081

Georgia Panayiotou, PhD

Role: backup

georgiap@ucy.ac.cy

+35722892081

Other Identifiers

MashUP_FeasibilityRCT1

Identifier Type: -

Identifier Source: org_study_id