NCT05598944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

October 22, 2022

Last Update Submit

January 29, 2023

Conditions

Keywords

Sustainable DevelopmentMindfulnessCurriculum DesignCognitive Behavioral TrainingLearning in Higher EducationEmployability

Outcome Measures

Primary Outcomes (6)

  • 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"

    Baseline, 4 months

  • 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.

    Baseline, 4 months

  • 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".

    Baseline, 4 months

  • 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".

    Baseline, 4 months

  • 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".

    Baseline, 4 months

  • 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"

    Baseline, 4 months

Secondary Outcomes (4)

  • Change in Academic Performance

    Baseline, 12 months

  • Qualitative questionnaire on students' experience

    Time Frame: 4 months

  • Control questions to test internal validity

    Baseline, 4 months

  • Eysenck Personality Inventory (EPI)

    Baseline, 4 months

Study Arms (3)

UGRComp group

EXPERIMENTAL

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

MBSR group

EXPERIMENTAL

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

Neuro-muscular stimulation group

ACTIVE COMPARATOR

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.

Other: Neuro-muscular stimulation

Interventions

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".

Also known as: Mindfulness-Based Stress Reduction program
MBSR group

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.

Also known as: The EU socio-emotional based program adapted to the UGR context
UGRComp group

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.

Neuro-muscular stimulation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students enrolled at the University of Granada, Degree level

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18071, Spain

Location

Related Publications (14)

  • 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.

    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.

    PMID: 21193491BACKGROUND
  • 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.

    PMID: 16443717BACKGROUND
  • 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.

    PMID: 12916575BACKGROUND
  • 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

    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.

    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.

    PMID: 16004657BACKGROUND
  • 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.

    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.

    BACKGROUND
  • Pérez JC. Adaptación y validación española del "Trait Emotional Intelligence Questionnaire"(TEIQue) en población universitaria. Encuentros en Psicología Social. 2003; 1(5): 278-283.

    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.

    PMID: 23458548BACKGROUND
  • 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.

    PMID: 7042457BACKGROUND
  • 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.

    PMID: 28298898BACKGROUND
  • 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.

    PMID: 27448268BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Mercedes García de Quesada, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2022

First Posted

October 28, 2022

Study Start

October 20, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations