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

December 1, 2023 updated by: Mercedes García de Quesada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • The EU socio-emotional based program adapted to the UGR context
Experimental: 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.
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".
Other Names:
  • Mindfulness-Based Stress Reduction program
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Spanish Short Self-Regulation Questionnaire (SSSRQ)
Time Frame: Baseline, 4 months
17 items self-report scale, translated and validated into Spanish, that measures cognitive and behavioural aspects of self-regulation (Garzón et al. 2017). Respondents rate a series of statements on a 5-point Likert scale, with 1 being "strongly disagree" and 5 being "strongly agree"
Baseline, 4 months
Change on Guilford's Alternative Uses Test (GAU)
Time Frame: Baseline, 4 months
Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.
Baseline, 4 months
Change on the Five Facets Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline, 4 months
A 39-item self-report scale, translated and validated into Spanish, that measures mindfulness traits (Baer et al 2006, 2010; Cebolla et al 2012). Respondents rate a series of statements on a 5-point Likert scale, with 1 being "never" and 5 being "very often".
Baseline, 4 months
Change on the Depression Anxiety Stress Scale (DASS)
Time Frame: Baseline, 4 months
A 21-item self-report scale, translated and validated into Spanish, that measures depression, anxiety and stress levels (Henry and Crawford 2005, Bados et al. 2005). Respondents rate a series of statements on a 4-point Likert scale, with 0 being "not at all true of me" and 3 being "very true of me".
Baseline, 4 months
Change on the Mind Wandering questionnaire (MW)
Time Frame: Baseline, 4 months
An 8-item self-report scale, translated and validated into Spanish, that measures the levels of the mind wandering trait (Carriere et al. 2013). Respondents rate a series of statements on a 7-point Likert scale, with 1 being "almost never" and 7 being "almost always".
Baseline, 4 months
Change on the Basic Empathy Scale (BES)
Time Frame: Baseline, 4 months
A 20-item self-report scale, translated and validated into Spanish, that measures affective and cognitive empathy (Villadangos et al. 2016). Respondents rate a series of statements on a 5-point Likert scale, with 1 being "strongly disagree" and 5 being "strongly agree".
Baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative questionnaire on students' experience
Time Frame: 4 months
This qualitative questionnaire with open ended questions builds directly on the results from the quantitative phase. The quantitative results are interpreted in more detail through the qualitative data.
4 months
Eysenck Personality Inventory (EPI)
Time Frame: Baseline, 4 months
A 24-item self-report scale to assess neuroticism and social conformity and desirability. Respondents rate a series of statements on a yes/no scale.
Baseline, 4 months
Academic qualifications extracted from the subjects' undergraduate transcript
Time Frame: Up to 4 years
Results from primary outcome are associated with academic performance of students' core subjects.
Up to 4 years
Concentration of participants
Time Frame: Baseline, 4 months
Every two questionnaires a control question will be inserted in order to test internal validity.
Baseline, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercedes García de Quesada

Collaborators

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

Investigators

  • Principal Investigator: Mercedes T. García de Quesada, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cívitas-UGR 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Compassion

Clinical Trials on Más Presente, the UGRComp program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe