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The Effects of Psycho-educational Training in Undergraduate Students at the University of Granada (Spain)

Primary Purpose

Empathy, Compassion, Attention

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The MBSR program
Más Presente, the UGRComp program
Neuro-muscular stimulation
Sponsored by
Mercedes García de Quesada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Empathy focused on measuring Sustainable Development, Mindfulness, Curriculum Design, Cognitive Behavioral Training, Learning in Higher Education, Employability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Granada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

UGRComp group

MBSR group

Neuro-muscular stimulation group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change on the Spanish Short Self-Regulation Questionnaire (SSSRQ)
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"
Change on Guilford's Alternative Uses Test (GAU)
Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.
Change on the Five Facets Mindfulness Questionnaire
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".
Change on the Depression Anxiety Stress Scale
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".
Change on the Mind Wandering questionnaire
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".
Change on the Basic Empathy Scale (BES)
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"

Secondary Outcome Measures

Change in Academic Performance
Assessing whether academic record data provided by the UGR (e.g., grades) improve across the baseline to 12-month assessment period.
Qualitative questionnaire on students' experience
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.
Control questions to test internal validity
Every two questionnaires a control question such as "For this question, please select the response number three" will be inserted among the questionnaire items. The aim is to test whether students are adequately answering and paying attention (or in contrast are answering randomly). An ex-post evaluation will be carried out to consider which subjects to include in the final data analysis.
Eysenck Personality Inventory (EPI)
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.

Full Information

First Posted
October 22, 2022
Last Updated
January 29, 2023
Sponsor
Mercedes García de Quesada
Collaborators
Cívitas-UGR Chair: Sustainability, Innovation and Development, Granada, Spain, Teryos Functional Clinical Medicine, Granada, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05598944
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mercedes García de Quesada
Collaborators
Cívitas-UGR Chair: Sustainability, Innovation and Development, Granada, Spain, Teryos Functional Clinical Medicine, Granada, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UGRComp group
Arm Type
Experimental
Arm Description
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.
Arm Title
MBSR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Neuro-muscular stimulation group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The MBSR program
Other Intervention Name(s)
Mindfulness-Based Stress Reduction program
Intervention Description
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
Intervention Name(s)
Más Presente, the UGRComp program
Other Intervention Name(s)
The EU socio-emotional based program adapted to the UGR context
Intervention Description
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
Other
Intervention Name(s)
Neuro-muscular stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on the Spanish Short Self-Regulation Questionnaire (SSSRQ)
Description
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"
Time Frame
Baseline, 4 months
Title
Change on Guilford's Alternative Uses Test (GAU)
Description
Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.
Time Frame
Baseline, 4 months
Title
Change on the Five Facets Mindfulness Questionnaire
Description
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".
Time Frame
Baseline, 4 months
Title
Change on the Depression Anxiety Stress Scale
Description
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".
Time Frame
Baseline, 4 months
Title
Change on the Mind Wandering questionnaire
Description
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".
Time Frame
Baseline, 4 months
Title
Change on the Basic Empathy Scale (BES)
Description
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"
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Change in Academic Performance
Description
Assessing whether academic record data provided by the UGR (e.g., grades) improve across the baseline to 12-month assessment period.
Time Frame
Baseline, 12 months
Title
Qualitative questionnaire on students' experience
Description
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.
Time Frame
Time Frame: 4 months
Title
Control questions to test internal validity
Description
Every two questionnaires a control question such as "For this question, please select the response number three" will be inserted among the questionnaire items. The aim is to test whether students are adequately answering and paying attention (or in contrast are answering randomly). An ex-post evaluation will be carried out to consider which subjects to include in the final data analysis.
Time Frame
Baseline, 4 months
Title
Eysenck Personality Inventory (EPI)
Description
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.
Time Frame
Baseline, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes García de Quesada, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
21193491
Citation
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.
Results Reference
background
PubMed Identifier
16443717
Citation
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.
Results Reference
background
PubMed Identifier
12916575
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
16004657
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Pérez JC. Adaptación y validación española del "Trait Emotional Intelligence Questionnaire"(TEIQue) en población universitaria. Encuentros en Psicología Social. 2003; 1(5): 278-283.
Results Reference
background
PubMed Identifier
23458548
Citation
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.
Results Reference
background
PubMed Identifier
7042457
Citation
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.
Results Reference
background
PubMed Identifier
28298898
Citation
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.
Results Reference
background
PubMed Identifier
27448268
Citation
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.
Results Reference
background

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The Effects of Psycho-educational Training in Undergraduate Students at the University of Granada (Spain)

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