Emotion Regulation For All (ER4ALL) Study

NCT05746234 | Unknown DMC

• 1 other identifier: MashUP_FeasibilityRCT1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation

Keywords

Emotion regulation, Mental Health, Socio-Emotional Learning

Outcome Measures

Primary Outcomes (2)

• Feasibility of the course

  At post-training, principal researchers involved in the development and delivery of the intervention in each site, will complete Structured Assessment of FEasibility (SAFE; Bird et al. 2014), a standardised measure of the feasibility of complex interventions (Bird et al. 2014). The SAFE measure comprises 16 items grouped into two sub-scales: Blocks (8 items) and Enablers (8 items). SAFE guidelines recommend that reviewers attend to the individual items of the scale, instead of using summary scores, since items have unequal weight. Τhe tool has shown excellent interrater reliability (k = 0.84, 95% CI 0.79-0.89) and test-retest reliability (k = 0.89, 95% CI 0.85-0.93).

  up to 10 weeks

• Acceptability of the course

  At post-training, all participants will complete a course satisfaction/acceptability questionnaire. The questionnaire will consist of two parts: In part A (quantitative) students will be asked several Likert-scale questions, while part B (qualitative) while contain open-ended response questions relating to their experience, satisfaction, and the challenges/enablers associated with design and implementation of the course. Qualitative data from open-ended questions will be considered alongside the quantitative measures to assess the feasibility of the intervention. The feasibility and acceptability of the intervention will be evaluated, using multiple primary endpoints such as: 1. Adherence (Total registrations, Attendance Rates, Homework Adherence, Dropouts) 2. Course acceptability and satisfaction ratings 3. Training preference.

  up to 10 weeks

Secondary Outcomes (7)

• Emotion Beliefs Questionnaire

  up to 10 weeks

• Acceptance and Action Questionnaire-II

  up to 10 weeks

• Psyflex

  up to 10 weeks

• Positive Mental Health Scale (PMH-scale)

  up to 10 weeks

• Depression Anxiety Stress Scales (DASS-21)

  up to 10 weeks

Other Outcomes (2)

• Participants characteristics

  up to 10 weeks

• Fidelity

  up to 10 weeks

Study Arms (2)

Music-Based ER module

EXPERIMENTAL

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.

Behavioral: Emotion Regulation Course

Standard ER module

ACTIVE COMPARATOR

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).

Behavioral: Emotion Regulation Course

Interventions

Emotion Regulation Course 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.

Also known as: ER4ALL course

Music-Based ER module; Standard ER module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Cyprus: lead
• VU University of Amsterdam: collaborator
• University of Crete: collaborator
• Eotvos Lorand University: collaborator

Study Sites (1)

University of Cyprus

Nicosia, 1678, Cyprus

RECRUITING

MeSH Terms

Conditions

Emotional Regulation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Georgia Panayiotou, Professor of Clinical Psychology, Department of Psychology and Center for Applied Neuroscience

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: March 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: February 28, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

CY (1)