NCT04392869

Brief Summary

The Faculty of Translation and Interpreting of the University of Granada (UGR) has been leading the lists of the best faculties in this area in Spain and abroad for years. This has largely defined the profile of its students as high performing and, therefore, more prone to display maladaptive perfectionism which can lead to psychological distress (Rice et al 2006). However psychological distress is not something that only affects high profile students. Several studies report overall greater stress levels among undergraduate students when compared to general population levels (Ramasubramanian 2017). In fact, it is estimated that nearly 40 percent of university students experience mild to severe depressive symptoms with over 50 percent of students predicted to experience some level of depressive symptomatology during their college years (Pogrebtsova et al 2018: 46). Coping with cognitive and emotional challenges is therefore a desirable aim for every student on a daily bases. It is within this framework that CRAFTftiugr was born, a teaching innovation project, which is the result of the interaction among experts in mindfulness, lecturers and researchers in Translation and Interpreting and Experimental Psychology, students, Administrative and Support Staff and social stakeholders in the context of Higher Education. The main objective of the study is to test whether participating in a course on mindfulness-based techniques 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 mindfulness based programs, MBSR and CRAFT, on the students' ability to improve specific aspects of cognition, emotional intelligence, creativity or academic performance among others. Both mindfulness-based 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 outcomes, a curriculum applied to Translation and Interpreting Studies will be designed aimed at preventing the development of psychological stress, perfectionism and other anxiety disorders, maximizing comfort in the Higher Education context and, ultimately, improving academic achievement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

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 23, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

May 9, 2020

Last Update Submit

November 26, 2022

Conditions

Keywords

Academic PerformanceMindfulnessLearning in Higher EducationEmotional RegulationCurriculum DesignCognitive Behavioral TrainingTranslation and Interpreting Studies

Outcome Measures

Primary Outcomes (9)

  • Change on the Five Facets Mindfulness Questionnaire

    A 39-item self-report scale, translated and validated in 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 Emotion Regulation Questionnaire

    A 10-item self-report scale, translated and validated in Spanish, that measures emotion regulation (Gross and John 2003; Cabello, Salguero, Fernández-Berrocal and Gross 2013). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

    Baseline, 4 months

  • Change on the Depression Anxiety Stress Scale

    A 21-item self-report scale, translated and validated in 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 Trait Emotional Intelligence Questionnaire

    A 30-item self-report scale, translated and validated in Spanish, that measures self-regulation, psychological wellbeing, sociability and emotionality (Petrides et al 2016, Pérez 2003). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

    Baseline, 4 months

  • Change on the Cultural Intelligence Scale

    A 20-item self-report scale, translated and validated in Spanish, that measures cultural intelligence (Ang et al 2007; Moyano et al 2014). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

    Baseline, 4 months

  • Change on the Mind Wandering questionnaire

    An 8-item self-report scale, translated and validated in 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 ANTIVEA task

    Online cognitive test, assessing several objective indices (based on participant's reaction times and accuracy) of attention and vigilance (Luna et al 2018).

    Baseline, 4 months

  • Change on the Test on creativity

    Face-to-face questionnaire, in Spanish, measuring divergent thinking (Berná and Limiñana 2010, Elisondo et al 2017).

    Baseline, 4 months

  • Change on the Motivated Strategies for Learning Questionnaire

    A 52-item self-report scale, translated and validated in Spanish, that measures motivation and learning strategies (Rojas-Ospina and Valencia-Serrano 2019; Muñoz and Asencio 2018; Pintrich et al 1987, Pintrich and De Groot 1990; Martínez Fernández and Galán 2000). Respondents rate a series of statements on a 5-point likert scale, with 1 being "I strongly disagree" and 5 being "I totally agree".

    Baseline, 4 months

Secondary Outcomes (2)

  • Academic performance assessment

    Up to 4 years

  • Qualitative questionnaire on students' experience

    4 months

Study Arms (3)

CRAFT group

EXPERIMENTAL

This arm will instruct the students on an adapted and extended version of the CRAFT program. This is a mindfulness based program which is a systematic combination of practices derived from ancient philosophies, such as yoga and Buddhism, in conjunction with more recent disciplines such as mindfulness, emotional intelligence and positive psychology. The contents are structured along in five consecutive modules aimed at cultivating and enhancing consciousness, relaxation and regulation, attention, bliss and transcendence.

Behavioral: The CRAFT program (adapted due to COVID-19)

MBSR group

EXPERIMENTAL

This arm will instruct the students on an adapted and extended version of 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 (adapted due to COVID-19)

No intervention group

NO INTERVENTION

This group does not receive any instruction. The aim of this arm is to determine if there are any differences in outcomes between the two groups that receive intervention and this one.

Interventions

The CRAFT program was created by P. Posadas, PhD (Posadas 2017). This program aims to cultivate positive emotions toward oneself and others, engaging socio-emotional processes and activating traits such as empathy, motivation and creativity. It has been previously implemented in other Higher Education Institutions (Rull et al 2019, Posadas 2018, 2019). It originally consists of 8 weekly classes, 2 hours each (18 hours direct instruction) but it has been adapted and extended due to the situation caused by the COVID19 pandemic. The resulting 12 week program is structured along the following topics: Consciousness, Relaxation-Breathing-Regulation, Mindfulness/Full Attention, Bliss, Transcendence, Communication as Connection, Mindfully, Consciously and Blissfully Living our Daily Lives, My Work of Art "My Wonderful Craft Work Here and Now", Time and Energy Management, Passion and Compassion in the COVID context.

Also known as: The CRAFT (Conscience, Relaxation-regulation, Attention, Bliss and Transcendence) program, adapted due to COVID-19
CRAFT group

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) but it has been adapted and extended due to the situation caused by the COVID19 pandemic. The resulting 12 week program is structured along the following topics: The Underpinnings of MBSR, The Perception of Reality, Emotion Regulation, Understanding Stress: The Mind-Body Relation, Responding to Stress, Communication and Personal Relations, Daily Life Management, My Personal Plan: "The First Week of the Rest of my Life", Time and Energy Management, Emotion Regulation in the COVID context.

Also known as: The MBSR (Mindfulness Based Stress Reduction) program, adapted due to COVID-19
MBSR group

Eligibility Criteria

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

You may qualify if:

  • Students from 1st year of the joint Bachelor's Degree in Translation and Interpreting, and Tourism of the University of Granada.
  • Students from 1st year of the Bachelor's Degree in Translation and Interpreting of the University of Granada.
  • Students from 4th year of the Bachelor's Degree in Translation and Interpreting of the University of Granada.

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)

Department of Translation and Interpreting of the University of Granada

Granada, 18002, Spain

Location

Related Publications (27)

  • 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
  • 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
  • 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
  • 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
  • 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
  • Luna FG, Marino J, Roca J, Lupianez J. Executive and arousal vigilance decrement in the context of the attentional networks: The ANTI-Vea task. J Neurosci Methods. 2018 Aug 1;306:77-87. doi: 10.1016/j.jneumeth.2018.05.011. Epub 2018 May 20.

    PMID: 29791865BACKGROUND
  • Pogrebtsova E, Craig J, Chris A, O'Shea D, Gonzalez-Morales MG. Exploring daily affective changes in university students with a mindful positive reappraisal intervention: A daily diary randomized controlled trial. Stress Health. 2018 Feb;34(1):46-58. doi: 10.1002/smi.2759. Epub 2017 May 17.

    PMID: 28512859BACKGROUND
  • Ang S, Van Dyne L, Koh C, Ng KY, Templer KJ, Tay C, Chandrasekar NA. Cultural intelligence: Its measurement and effects on cultural judgment and decision making, cultural adaptation and task performance. Manage Organ Rev [Internet]. 2007; 3(3): 335-71. Available from: www.scopus.com

    BACKGROUND
  • Berná JC, Limiñana Gras RM. The genie in a bottle. the CREA test, questions and creativity. introduction to special theme

    BACKGROUND
  • 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
  • Elisondo RC, Donolo DS, Limiñana-Gras RM. The measure of originality in CREA test responses. An Psicol [Internet]. 2018; 34(1): 197-210. Available from: www.scopus.com

    BACKGROUND
  • Martínez Fernández JR and Galán F. Estrategias de aprendizaje, motivación y rendimiento académico en alumnos universitarios. Revista Española de Orientación y Psicopedagogía. 2000; 11(19): 35-50.

    BACKGROUND
  • Moyano M, Tabernero C, Melero R, Trujillo HM. Spanish version of the cultural intelligence scale (CQS). Rev Psicol Soc [Internet]. 2014; 30(1): 182-216. Available from: www.scopus.com

    BACKGROUND
  • Muñoz GN, Asencio EN. Improvement of self-regulation learning strategies at university: The impact of a program of academic fit to the degree. Bordon, Rev Pedagog [Internet]. 2018; 70(4): 121-36. Available from: www.scopus.com

    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. Available from: www.scopus.com

    BACKGROUND
  • Pintrich PR, De Groot EV. Motivational and self-regulated learning components of classroom academic performance. J Educ Psychol [Internet]. 1990; 82(1): 33-40. Available from: www.scopus.com

    BACKGROUND
  • Pintrich PR, McKeachie WJ, Smith DAF, Doljanac R, Lin YG, Naveh-Benjamin M, Crooks T, Karabenick S. The Motivated strategies for learning questionnaire. Ann Arbor, MI: University of Michigan, National Center for Research to Improve Postsecondary Teaching and Learning (NCRIPTAL); 1987.

    BACKGROUND
  • Posadas P. Mindfulness para músicos. Programa CRAFT. In: Lag López N, editor. Educación Musical: Recursos para el cambio metodológico. Málaga: Procompal Publicaciones; 2018. p. 221-226.

    BACKGROUND
  • Posadas P, inventor. Programa CRAFT en el marco del Proyecto MACF (Mundo Atento Consciente y Feliz) basado en Mindfulness, Yoga, Psicología Positiva y Sugestopedia orientado a las Enseñanzas de Régimen Especial: Enseñanzas Artísticas e Idiomas.

    BACKGROUND
  • Posadas P. Programa CRAFT. Mindfulness, Inteligencia Emocional, Psicología Positiva y Yoga en Educación. Granada: Educatori; 2019.

    BACKGROUND
  • Ramasubramanian S. Mindfulness, stress coping and everyday resilience among emerging youth in a university setting: A mixed methods approach. Int J Adolesc Youth [Internet]. 2017; 22(3): 308-21. Available from: www.scopus.com

    BACKGROUND
  • Rice KG, Leever BA, Christopher J, Porter JD. Perfectionism, stress, and social (dis)connection: A short-term study of hopelessness, depression, and academic adjustment among honors students. J Couns Psychol [Internet]. 2006; 53(4): 524-34. Available from: www.scopus.com

    BACKGROUND
  • Rojas-Ospina T, Valencia-Serrano M. Adaptation and validation of a questionnaire on motivation self-regulation strategies in college students. Psykhe [Internet]. 2019; 28(1): 1-15. Available from: www.scopus.com

    BACKGROUND
  • Rull LM, de Julián MPP, Martín JLO. Learn English to the rhythm of Bach: An eclectic methodology for learning English based on suggestopedia and the CRAFT program. Int J Pedagogy Curric [Internet]. 2019; 26(1): 1-15. Available from: www.scopus.com

    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
  • Cásedas L, Funes MJ, Ouellet M, García de Quesada M. Training transversal competences in a bachelor's degree in translation and interpreting: preliminary evidence from a clinical trial. The Interpreter and Translator Trainer. 2022. DOI: 0.1080/1750399X.2022.2148964

    RESULT

Related Links

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersEmotional Regulation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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 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 Translation Department is appointed. Outcome Assessors: all measures except one are collected online via the UGR LimeSurvey platform and no recording of group assignment is introduced in the system. The only face-to-face measure is administered at the baseline by another member who is blind to hypothesis. 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, 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 two groups: the MBSR group that receives an extended and adapted version of the MBSR program and the CRAFT group that receives an extended and adapted version of the CRAFT. All participants are asked to fill in an informed consent and a demographic questionnaire to determine eligibility. Eligible participants are randomly assigned to either the MBSR group or the CRAFT group. Both programs are taught simultaneously. The outcome measures will be evaluated against a third group who receives no intervention at all and could not be randomly assigned. This passive control group is formed with students from the same courses as experimental participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mercedes García de Quesada, PhD Associate Professor-tenured

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 19, 2020

Study Start

October 23, 2019

Primary Completion

July 31, 2020

Study Completion

October 31, 2020

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Data set from the ANTI-VEA task (one of our primary outcomes) will become part of a more general database belonging to the UGR Cognitive Neuroscience research group (HUM-379). This group is responsible for the design of the task with the aim to study attentional processes. Three of the researchers from the present project belong to such research team.

Time Frame
From data collection.
Access Criteria
Data set from the ANTI-VEA task will only be shared anonymized.

Available IPD Datasets

Summary and comparison of mindfulness based programs (clinicaltrialsCRAFT)Access
Human Subjects Review (clinicaltrialsCRAFT)Access
Informed Consent Form (clinicaltrialsCRAFT)Access
Official CRAFTftiugr logo (clinicaltrialsCRAFT)Access

Locations