Psycho-educational Training in Undergraduate Students at the University of Granada (Spain). Second Edition

NCT ID: NCT05775978

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-06-07

Brief Summary

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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; a step further is needed. It's necessary to 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.

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

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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 in neuro-muscular stimulation.

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, the 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 used 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.

Conditions

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Empathy Compassion Attention Psychological Distress Life Stress Anxiety Creativity Emotional Intelligence

Keywords

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Sustainable Development Mindfulness Curriculum Design Cognitive Behavioral Training Learning in Higher Education Employability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Investigator: researchers have no information on participants' allocation in the groups; a research assistant from the Cognitive Neuroscience Group of the CIMCYC is designated for this purpose. None of the participants are students of any of the researchers. For the purpose of communicating with the participants over group allocation, another lecturer from the UGR is appointed. Outcome Assessors: all measures are collected online via the UGR LimeSurvey platform and no recording of group assignment is introduced in the system. Care providers: they are not informed about the outcome measures or specific research hypothesis regarding expected effects for each program. Participants: although it is not possible to blind their assignment to the groups in this type of study, they are not informed about the specific hypothesis regarding the expected outcomes of the programs.

Study Groups

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UGRComp group

This arm will instruct the students on the Más Presente program. This is a socio-emotional competence-based program which has been designed following the European LifeComp framework. This program is a combination of theory and practice aimed at developing the core elements of personal, social and learning to learn key competences for lifelong learning.

Group Type EXPERIMENTAL

Más Presente, the UGRComp program

Intervention Type BEHAVIORAL

Más Presente, the UGRComp program is based upon the European LifeComp framework (Sala, Punie, Garkov and Cabrera Giraldez 2020) and covers intra and interpersonal, emotional, cognitive and metacognitive aspects. Created at the University of Granada by an interdisciplinary group of experts, it focuses on three core elements (self-regulation, empathy and growth mindset) as they are the pre-requisites for developing all other elements across framework areas. It consists of 8 weekly classes, 2 hours each, together with a day of intensive practice. The program is structured along the following topics: The Underpinnings of Más Presente; Awareness and Concentration: our Body; Managing our Emotional Laberynth; Walking with Directionality, Sense and Conscience; Empathy, Presence and Connection; Empathic Listening and Honest Expression: Non-violent communication; Growth Mindset, Creativity and Divergent Thinking; And Now what? The First Day of the Rest of My Life.

MBSR group

This arm will instruct the students on the Mindfulness-Based Stress Reduction (MBSR) program. The MBSR is a secular, evidence-based practice originally developed for chronic pain, but which has reported positive results among an array of clinical and nonclinical populations. This program aims to cultivate non-judgmental attention to and awareness of present moment experience while promoting stress reduction.

Group Type EXPERIMENTAL

The MBSR program

Intervention Type BEHAVIORAL

The MBSR program is a group-based therapy which teaches mindfulness skills through a range of formal and informal mindfulness practices. Created by Kabat-Zinn (1982), in the current study it is taught by an officially accredited instructor and is compliant with the guidelines established by Brown University and the University of Massachusetts, USA. It originally consists of 8 weekly classes, 2 hours each (18 hours direct instruction), together with a day of intensive practice. The program is structured along the following topics: The Underpinnings of MBSR; The Perception of Reality; Power in Being Present; Understanding Stress: The Mind-Body Relation; Responding to Stress; Communication and Personal Relations; Daily Life Management; My Personal Plan: "What lies ahead".

Neuro-muscular stimulation group

The students in this arm will receive training on physical wellbeing and neuro-muscular stimulation.

Non-specific factors such as number and duration of sessions, or instructor training and qualifications will match the other 2 experimental groups. Active ingredients such as mindfulness or socio-emotional training are not contained in the program.

Group Type ACTIVE_COMPARATOR

Neuro-muscular stimulation

Intervention Type BEHAVIORAL

Subjects will receive weekly sessions with a combination of educational sessions and specific physical exercises to enhance physical wellbeing and prevent neuro-degeneration . After spotting the therapeutic targets for each subject, a 4-phase program will be designed for each subject aimed at improving lifestyle habits and general wellbeing.

Interventions

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Más Presente, the UGRComp program

Más Presente, the UGRComp program is based upon the European LifeComp framework (Sala, Punie, Garkov and Cabrera Giraldez 2020) and covers intra and interpersonal, emotional, cognitive and metacognitive aspects. Created at the University of Granada by an interdisciplinary group of experts, it focuses on three core elements (self-regulation, empathy and growth mindset) as they are the pre-requisites for developing all other elements across framework areas. It consists of 8 weekly classes, 2 hours each, together with a day of intensive practice. The program is structured along the following topics: The Underpinnings of Más Presente; Awareness and Concentration: our Body; Managing our Emotional Laberynth; Walking with Directionality, Sense and Conscience; Empathy, Presence and Connection; Empathic Listening and Honest Expression: Non-violent communication; Growth Mindset, Creativity and Divergent Thinking; And Now what? The First Day of the Rest of My Life.

Intervention Type BEHAVIORAL

The MBSR program

The MBSR program is a group-based therapy which teaches mindfulness skills through a range of formal and informal mindfulness practices. Created by Kabat-Zinn (1982), in the current study it is taught by an officially accredited instructor and is compliant with the guidelines established by Brown University and the University of Massachusetts, USA. It originally consists of 8 weekly classes, 2 hours each (18 hours direct instruction), together with a day of intensive practice. The program is structured along the following topics: The Underpinnings of MBSR; The Perception of Reality; Power in Being Present; Understanding Stress: The Mind-Body Relation; Responding to Stress; Communication and Personal Relations; Daily Life Management; My Personal Plan: "What lies ahead".

Intervention Type BEHAVIORAL

Neuro-muscular stimulation

Subjects will receive weekly sessions with a combination of educational sessions and specific physical exercises to enhance physical wellbeing and prevent neuro-degeneration . After spotting the therapeutic targets for each subject, a 4-phase program will be designed for each subject aimed at improving lifestyle habits and general wellbeing.

Intervention Type BEHAVIORAL

Other Intervention Names

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The EU socio-emotional based program adapted to the UGR context Mindfulness-Based Stress Reduction program

Eligibility Criteria

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Inclusion Criteria

* Students enrolled at the University of Granada, Spain. Bachelor's Degree level

Exclusion Criteria

* Current psychotherapy or history of psychotic disorder or neurological condition.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cívitas-UGR Chair: Sustainability, Innovation and Development, Granada, Spain

UNKNOWN

Sponsor Role collaborator

Mercedes García de Quesada

OTHER

Sponsor Role lead

Responsible Party

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Mercedes García de Quesada

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mercedes T. García de Quesada, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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University of Granada

Granada, , Spain

Site Status

Countries

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Spain

References

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Sala A, Punie Y, Garkov V, Cabrera Giraldez M. LifeComp: The European framework for personal, social, and learning to learn key competence. Publications Office of the European Union. 2020.

Reference Type BACKGROUND

Baer RA, Samuel DB, Lykins EL. Differential item functioning on the Five Facet Mindfulness Questionnaire is minimal in demographically matched meditators and nonmeditators. Assessment. 2011 Mar;18(1):3-10. doi: 10.1177/1073191110392498. Epub 2010 Dec 30.

Reference Type BACKGROUND
PMID: 21193491 (View on PubMed)

Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

Reference Type BACKGROUND
PMID: 16443717 (View on PubMed)

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

Reference Type BACKGROUND
PMID: 12916575 (View on PubMed)

Cabello R, Salguero JM, Fernández-Berrocal P, Gross JJ. A Spanish adaptation of the emotion regulation questionnaire. Eur J Psychol Assess [Internet]. 2013; 29(4): 234-40. Available from: www.scopus.com

Reference Type BACKGROUND

Cebolla A, García-Palacios A, Soler J, Guillen V, Baños R, Botella C. Psychometric properties of the Spanish validation of the Five Facets of Mindfulness Questionnaire (FFMQ). The European Journal of Psychiatry. 2012; 26(2): 118-126.

Reference Type BACKGROUND

Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

Reference Type BACKGROUND
PMID: 16004657 (View on PubMed)

Bados A, Solanas A. Andrés R. Psychometric properties of the Spanish version of Depression, Anxiety and Stress Scales (DASS). Psicothema. 2005; 17(4): 679-683.

Reference Type BACKGROUND

Petrides KV, Mikolajczak M, Mavroveli S, Sanchez-Ruiz M-, Furnham A, Pérez-González J-. Developments in trait emotional intelligence research. Emot Rev [Internet]. 2016; 8(4): 335-41.

Reference Type BACKGROUND

Carriere JSA, Seli P, Smilek D. Wandering in both mind and body: individual differences in mind wandering and inattention predict fidgeting. Can J Exp Psychol. 2013 Mar;67(1):19-31. doi: 10.1037/a0031438.

Reference Type BACKGROUND
PMID: 23458548 (View on PubMed)

Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

Reference Type BACKGROUND
PMID: 7042457 (View on PubMed)

Garzon Umerenkova A, de la Fuente Arias J, Martinez-Vicente JM, Zapata Sevillano L, Pichardo MC, Garcia-Berben AB. Validation of the Spanish Short Self-Regulation Questionnaire (SSSRQ) through Rasch Analysis. Front Psychol. 2017 Mar 1;8:276. doi: 10.3389/fpsyg.2017.00276. eCollection 2017.

Reference Type BACKGROUND
PMID: 28298898 (View on PubMed)

Villadangos M, Errasti J, Amigo I, Jolliffe D, Garcia-Cueto E. Characteristics of Empathy in young people measured by the Spanish validation of the Basic Empathy Scale. Psicothema. 2016 Aug;28(3):323-9. doi: 10.7334/psicothema2016.6.

Reference Type BACKGROUND
PMID: 27448268 (View on PubMed)

Other Identifiers

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Cívitas-UGR 2023

Identifier Type: -

Identifier Source: org_study_id