Clinical trial NCT05598944: The Effects of Psycho-educational Training in Undergraduate Students at the University of Granada (Spain)
Official title: Testing the Effects of Two Psycho-educational Programs on Well Being and Academic Performance of Undergraduate Students at the University of Granada (Spain): An Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Compassion
Attention
Psychological Distress
Life Stress
Anxiety
Creativity
Emotional Intelligence
Keywords: Sustainable Development
Mindfulness
Curriculum Design
Cognitive Behavioral Training
Learning in Higher Education
Employability
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Cívitas-UGR Chair: Sustainability, Innovation and Development, Granada, Spain
name: Teryos Functional Clinical Medicine, Granada, Spain
First posted: 2022-10-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students are randomly assigned to three groups: the MBSR group that receives an adapted version of the MBSR program, the Más Presente group that receives training on transversal competences following the EU framework, LifeComp, and a third group that receives a neuro-muscular stimulation-based program. All participants are asked to fill in an informed consent and a demographic questionnaire to determine eligibility. Eligible participants are randomly assigned to either group. The three programs are given simultaneously.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The new professional profiles highlight the need to incorporate competences such as self-regulation, communication or growth mindset in the academia. Not only is this important for employability; we need to take a step further and equip learners with knowledge, skills and attitudes that help them become agents of change and shape sustainable futures in our current complex society.

Within the framework of an agreement signed between the University of Granada (UGR), Spain, and, one of the leading real state firms in Spain, Cívitas, a course and a parallel study have been launched that will provide research and training in these competences at a degree level. It is part of the Sustainable Human Development Training Pathway of the Vice-Rectorate for Equality, Inclusion and Sustainability, and 3 ECTS will be accredited for the completion of any of the UGR official degrees.

The main objective of the study is to test whether participating in a competence-based course can improve students' cognitive, emotional and personal traits as well as academic performance. Together with this main purpose, the present study also aims to compare the effects of two competence-based programs on the students' ability to improve specific aspects of cognition, emotional intelligence, creativity or academic performance among others. Both programs involve training sustained attention and an accepting and open attitude though they differ in several aspects of their methods, intention and aims.

Drawing conclusions from the research and outcomes, pedagogies which are best suited to develop theses competences at the Higher Education level will be suggested. Assessment and certification of this kind of competences will also be proposed.

Detailed description: The content of the UGRComp program (Más Presente, Arm 1) was designed in 2021 using the European LifeComp framework, the content of the Mindfulness-Based Stress Reduction program (MBSR, Arm 2) follows the University of Massachusetts and Brown University specifications, and the content of the neuro-muscular stimulation program has been designed for the purpose of this study and is a combination of educational sessions and specific physical exercises to enhance physical wellbeing and prevent neuro-degeneration (Arm 3). Arms 1 and 2 will attend classes at the University of Granada premises. Arm 3 will receive training under the supervision of a Clinic specialized in Sport Medicine, also in Granada (Spain). Instructors of the three arms are fully certified and have more than 10 years of professional experience in the field.

All UGR undergraduate students are informed and invited to participate both in the course and in the study. They can choose to participate either in the study alone, in the course alone or in both. However, they are advised that, in the event that there are more applications than places, priority will be given to those who have registered earlier and those who choose to do the study.

So that the 3 ECTS credits of the course can be validated for the completion of the Degree as prescribed by the European Higher Education Area, a petition was filed to the Vice-Rectorate for Teaching and Learning of the UGR. This petition was inserted in a broader proposal by the Vice-Rectorate for Equality, Inclusion and Sustainability as part of the Sustainable Human Development Training Pathway. In this petition, the content of the course, design and aim of the study, potential participants, duration and other issues related with the project were included and explained.

The UGR grants some facilities (lecture rooms and Administrative and Support Staff's help). Vice-Rectorate for Equality, Inclusion and Sustainability will be responsible of the accreditation and certification processes. The Civitas-UGR Chair is responsible of co-funding and the study members from the Mind, Brain and Behaviour Research Center (CIMCYC) of the University of Granada (Spain) are responsible of study design, LimeSurvey management, randomization and data analysis.

All participants are asked to fill in an informed consent, a demographic questionnaire to determine eligibility and a battery of tests. Eligible participants are randomly assigned to either group.

All questionnaires are uploaded to the UGR LimeSuvey platform, an open source online survey tool specially designed to develop, publish and collect survey responses. This software is the one recommended by the University of Granada to present and collect online data for research purposes as it complies with all current legislation and ensures that all protection data requirements are being effectively met.

For specific security guarantees, an institutional email account is created through which all communication related to the project is carried out. In the same line, all the documentation generated within the project is uploaded and shared on a virtual cloud owned by the UGR (www.ugrdrive.ugr.es).

It is expected to find improvements in all measures (psychological and academic) in the two experimental groups (students in Arms 1 and 2) after completing the course compared to pre-training and compared to an active control group (students in Arm 3). In order to measure potential specific effects of each mindfulness program, pre-training to post-training psychological measures will be compared once completed the program. Altogether, this applied study might help to elucidate whether these important transversal competences and soft skills can improve with mindfulness-based techniques and ultimately could be recommended as part of the official curricula of degree in Higher Education.

Eligibility criteria: Inclusion Criteria:

* Students enrolled at the University of Granada, Degree level

Exclusion Criteria:

* Current psychotherapy or history of psychotic disorder or neurological condition.
* Established formal meditation prior experience.

Primary outcomes:
measure: Change on the Spanish Short Self-Regulation Questionnaire (SSSRQ)
timeFrame: Baseline, 4 months
measure: Change on Guilford's Alternative Uses Test (GAU)
timeFrame: Baseline, 4 months
measure: Change on the Five Facets Mindfulness Questionnaire
timeFrame: Baseline, 4 months
measure: Change on the Depression Anxiety Stress Scale
timeFrame: Baseline, 4 months
measure: Change on the Mind Wandering questionnaire
timeFrame: Baseline, 4 months
measure: Change on the Basic Empathy Scale (BES)
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in Academic Performance
timeFrame: Baseline, 12 months
measure: Qualitative questionnaire on students' experience
timeFrame: Time Frame: 4 months
measure: Control questions to test internal validity
timeFrame: Baseline, 4 months
measure: Eysenck Personality Inventory (EPI)
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Mercedes García de Quesada, PhD
role: PRINCIPAL_INVESTIGATOR
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