Psychological DistressCRAFTftiugrNCT04392869
The Effects of Mindfulness-based Training in Undergraduate Students of Translation and Interpreting
A study testing The CRAFT program (adapted due to COVID-19) and The MBSR program (adapted due to COVID-19) in people with Psychological Distress and Life Stress, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Life Stress, Anxiety
- What is being tested?
- The CRAFT program (adapted due to COVID-19) and The MBSR program (adapted due to COVID-19)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current psychotherapy or history of psychotic disorder or neurological condition.
- Established formal meditation prior experience.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Translation and Interpreting of the University of Granada
Granada, 18002
About this study
Official title: Testing the Effects of Two Mindfulness-based Programs on Well Being and Academic Performance of Undergraduate Students of Translation and Interpreting: An Interventional Study
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.
Read the detailed description
The first year of the project has been devoted to the design of the study, the creation of the curriculum content for the courses (see attached document), all the administrative procedures aimed at formally introducing a course of this type into the Bachelor's Degree in Translation and Interpreting, and applying and receiving approval from the UGR Ethics Committee on Human Research (CEIH), the UGR Human Subjects Protection Review Board (see attached document).
All 1st and 4th year 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.
So that the 4 ECTS credits of the mindfulness-based course can be validated for the completion of the Degree in Translation and Interpreting as prescribed by the European Higher Education Area, a petition was filed to the governing body of the Faculty of Translation and Interpreting of the UGR. 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 Faculty grants some facilities (lecture rooms and Administrative and Support Staff's help) and allows the validation of 4 ECTS credits in exchange for participation in the course.
In order to encourage participation in the study besides the 4 European Credit Transfer and Accumulation System (ECTS) credits obtained as a result of attending the course, they could receive a discount on the original price for the ECTS credit in case they also opt for participating in the study. If they are grant holders, they get a further discount.
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 the MBSR group or the CRAFT group. To ensure a balanced proportion of 1st and 4th year students in each group, the course year variable is blocked. Also, excluded students who follow the course, are assigned to both groups proportionally with the criterion of "being 1st or 4th year students".
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).
Both program instructors are fully qualified. Carmen Verdejo-Lucas (MA) is a certified MBSR instructor with more than 30 year experience. She is a clinical psychologist specialized in mindfulness and compassion based interventions. She is also a certified Cultivating Emotional Balance (CEB) instructor by Santa Barbara Institute for Consciousness Studies and has received training from some of the most outstanding figures in mindfulness and compassion: Jon Kabat-Zinn, Alan Wallace, Eve Eckman, Ronald Siegel, Paul Gilbert, Jonh Picock, Margaret Cullen and Gonzalo Brito. Pilar Posadas de Julián (PhD) is specialized in mindfulness in educational contexts. She did her degree in Translation and Interpreting, and her PhD in Linguistics and Language Learning. As a musician, she works as a full professor at the Department of Pedagogy and Singing of the Conservatoire for Music and Dance combining this job with university postgraduate lecturing at different universities and institutions in and outside Spain. With more than 30 year experience in yoga, meditation and relaxation techniques, she is an accredited practitioner in a variety of mindfulness and yoga based techniques. She has been IP in several teaching innovation projects and has been awarded different prizes.
Due to the health emergency crisis caused by the COVID-19 pandemic, following instructions by our university (https://covid19.ugr.es/), the original study design has been changed from crossover to parallel. Contents of the programs and teaching methodology have also changed accordingly to adapt to online classes. Both programs are adapted and extended due to the circumstances.
Data collection is done at two different points in time: 1, before initiating the intervention, and 2, at the end of the intervention. Both data gathering phases lasts for approximately 15 days.
At the baseline, the only face-to-face measure is administered as such by another member who is blind to hypothesis. Due to the exigencies of health emergency situation and the impossibility to administer this measure face to face at the end of the intervention, it is also uploaded to the LimeSurvey platform and administered online at the end of the intervention.
The University of Granada General Foundation was the entity appointed to carry out all the administrative procedures (participants' enrollment, payment of fees, participants' medical insurance, certificate issuing at the end of the course and the like). The Chair in Conscience and Development of the University of Granada (Spain) is responsible of co-funding and the study members from the Cognitive Neuroscience Group (HUM-379, https://www.ugr.es/~jcarlosresina/Home.html) at the Mind, Brain and Behavior Research Centre (CIMCYC) of the University of Granada (Spain) are responsible of randomization and data analysis.
It is expected to find improvements in all measures (psychological and academic) in both groups after completing the course compared to pre-training and compared to a passive control group (students from the same degree that didn't chose to receive the course during the present academic year). In order to measure potential specific effects of each mindfulness program, pre-training to post-training psychological measures will be compared once completed the first program. Altogether, this applied study might help to elucidate whether these important transversal competences and soft skills in Translation and Interpreting can improve with mindfulness-based techniques and ultimately could be recommended as part of the official curricula of the Translating and Interpreting degree.
- Conditions
- Psychological Distress, Life Stress, Anxiety, Perfectionism, Emotional Intelligence, Creativity
- Being tested
- The CRAFT program (adapted due to COVID-19), The MBSR program (adapted due to COVID-19)
- Keywords
- Academic Performance, Mindfulness, Learning in Higher Education, Emotional Regulation, Curriculum Design, Cognitive Behavioral Training, Translation and Interpreting Studies
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The CRAFT program (adapted due to COVID-19)Behavioural
Also called The CRAFT (Conscience, Relaxation-regulation, Attention, Bliss and Transcendence) program, adapted due to COVID-19
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.
The MBSR program (adapted due to COVID-19)Behavioural
Also called The MBSR (Mindfulness Based Stress Reduction) program, adapted due to COVID-19
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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).
Measured: 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).
Measured: 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".
Measured: Baseline, 4 months
Secondary outcomes (2)
Academic performance assessment
Results from primary outcome are associated with academic performance of students' core subjects.
Measured: Up to 4 years
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start23 Oct 2019
- Primary completion31 Jul 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Chair in Conscience and Development (UGR), Mind, Brain and Behaviour Research Centre (CIMCYC)
- Responsible party
- Principal investigator, Mercedes García de Quesada, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392869
- Sponsor's protocol ID
- PIBPD 431 (PPFID 2018-2020)
- Acronym
- CRAFTftiugr
- Status last verified
- Nov 2022
- First submitted
- 9 May 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21193491Baer 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.
PubMed 16443717Carriere 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.
PubMed 23458548Gross 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.
PubMed 12916575Henry 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.
PubMed 16004657Kabat-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.
PubMed 7042457Luna 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.
PubMed 29791865Pogrebtsova 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.
PubMed 28512859Ang 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
Berná JC, Limiñana Gras RM. The genie in a bottle. the CREA test, questions and creativity. introduction to special theme
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
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
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.
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
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of Two Mindfulness-based Programs on Well Being and Academic Performance of Undergraduate Students of Translation and Interpreting: An Interventional Study
- ClinicalTrials.gov ID
- NCT04392869
- Acronym / sponsor ID
- CRAFTftiugr / PIBPD 431 (PPFID 2018-2020)
- Conditions
- Psychological Distress, Life Stress, Anxiety, Perfectionism, Emotional Intelligence, Creativity
- Keywords
- Academic Performance, Mindfulness, Learning in Higher Education, Emotional Regulation, Curriculum Design, Cognitive Behavioral Training, Translation and Interpreting Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Chair in Conscience and Development (UGR), Mind, Brain and Behaviour Research Centre (CIMCYC)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first year of the project has been devoted to the design of the study, the creation of the curriculum content for the courses (see attached document), all the administrative procedures aimed at formally introducing a course of this type into the Bachelor's Degree in Translation and Interpreting, and applying and receiving approval from the UGR Ethics Committee on Human Research (CEIH), the UGR Human Subjects Protection Review Board (see attached document).
All 1st and 4th year 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.
So that the 4 ECTS credits of the mindfulness-based course can be validated for the completion of the Degree in Translation and Interpreting as prescribed by the European Higher Education Area, a petition was filed to the governing body of the Faculty of Translation and Interpreting of the UGR. 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 Faculty grants some facilities (lecture rooms and Administrative and Support Staff's help) and allows the validation of 4 ECTS credits in exchange for participation in the course.
In order to encourage participation in the study besides the 4 European Credit Transfer and Accumulation System (ECTS) credits obtained as a result of attending the course, they could receive a discount on the original price for the ECTS credit in case they also opt for participating in the study. If they are grant holders, they get a further discount.
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 the MBSR group or the CRAFT group. To ensure a balanced proportion of 1st and 4th year students in each group, the course year variable is blocked. Also, excluded students who follow the course, are assigned to both groups proportionally with the criterion of "being 1st or 4th year students".
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).
Both program instructors are fully qualified. Carmen Verdejo-Lucas (MA) is a certified MBSR instructor with more than 30 year experience. She is a clinical psychologist specialized in mindfulness and compassion based interventions. She is also a certified Cultivating Emotional Balance (CEB) instructor by Santa Barbara Institute for Consciousness Studies and has received training from some of the most outstanding figures in mindfulness and compassion: Jon Kabat-Zinn, Alan Wallace, Eve Eckman, Ronald Siegel, Paul Gilbert, Jonh Picock, Margaret Cullen and Gonzalo Brito. Pilar Posadas de Julián (PhD) is specialized in mindfulness in educational contexts. She did her degree in Translation and Interpreting, and her PhD in Linguistics and Language Learning. As a musician, she works as a full professor at the Department of Pedagogy and Singing of the Conservatoire for Music and Dance combining this job with university postgraduate lecturing at different universities and institutions in and outside Spain. With more than 30 year experience in yoga, meditation and relaxation techniques, she is an accredited practitioner in a variety of mindfulness and yoga based techniques. She has been IP in several teaching innovation projects and has been awarded different prizes.
Due to the health emergency crisis caused by the COVID-19 pandemic, following instructions by our university (https://covid19.ugr.es/), the original study design has been changed from crossover to parallel. Contents of the programs and teaching methodology have also changed accordingly to adapt to online classes. Both programs are adapted and extended due to the circumstances.
Data collection is done at two different points in time: 1, before initiating the intervention, and 2, at the end of the intervention. Both data gathering phases lasts for approximately 15 days.
At the baseline, the only face-to-face measure is administered as such by another member who is blind to hypothesis. Due to the exigencies of health emergency situation and the impossibility to administer this measure face to face at the end of the intervention, it is also uploaded to the LimeSurvey platform and administered online at the end of the intervention.
The University of Granada General Foundation was the entity appointed to carry out all the administrative procedures (participants' enrollment, payment of fees, participants' medical insurance, certificate issuing at the end of the course and the like). The Chair in Conscience and Development of the University of Granada (Spain) is responsible of co-funding and the study members from the Cognitive Neuroscience Group (HUM-379, https://www.ugr.es/~jcarlosresina/Home.html) at the Mind, Brain and Behavior Research Centre (CIMCYC) of the University of Granada (Spain) are responsible of randomization and data analysis.
It is expected to find improvements in all measures (psychological and academic) in both groups after completing the course compared to pre-training and compared to a passive control group (students from the same degree that didn't chose to receive the course during the present academic year). In order to measure potential specific effects of each mindfulness program, pre-training to post-training psychological measures will be compared once completed the first program. Altogether, this applied study might help to elucidate whether these important transversal competences and soft skills in Translation and Interpreting can improve with mindfulness-based techniques and ultimately could be recommended as part of the official curricula of the Translating and Interpreting degree.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CRAFT group | Experimental | Behavioral: The CRAFT program (adapted due to COVID-19)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. |
| MBSR group | Experimental | Behavioral: The MBSR program (adapted due to COVID-19)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Current psychotherapy or history of psychotic disorder or neurological condition.
- Established formal meditation prior experience.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The CRAFT program (adapted due to COVID-19)Also: The CRAFT (Conscience, Relaxation-regulation, Attention, Bliss and Transcendence) program, adapted due to COVID-19The 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. | Behavioural | CRAFT group |
| The MBSR program (adapted due to COVID-19)Also: The MBSR (Mindfulness Based Stress Reduction) program, adapted due to COVID-19The 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. | Behavioural | MBSR group |
Primary outcome
Change on the Five Facets Mindfulness Questionnaire
Time frame: Baseline, 4 months
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".
Change on the Emotion Regulation Questionnaire
Time frame: Baseline, 4 months
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".
Change on the Depression Anxiety Stress Scale
Time frame: Baseline, 4 months
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".
Change on the Trait Emotional Intelligence Questionnaire
Time frame: Baseline, 4 months
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".
Change on the Cultural Intelligence Scale
Time frame: Baseline, 4 months
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".
Change on the Mind Wandering questionnaire
Time frame: Baseline, 4 months
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".
Change on the ANTIVEA task
Time frame: Baseline, 4 months
Online cognitive test, assessing several objective indices (based on participant's reaction times and accuracy) of attention and vigilance (Luna et al 2018).
Change on the Test on creativity
Time frame: Baseline, 4 months
Face-to-face questionnaire, in Spanish, measuring divergent thinking (Berná and Limiñana 2010, Elisondo et al 2017).
Change on the Motivated Strategies for Learning Questionnaire
Time frame: Baseline, 4 months
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".
2 secondary outcomes
Academic performance assessment
Time frame: Up to 4 years
Qualitative questionnaire on students' experience
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 21193491Baer 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.
- Background: PubMed 16443717Baer 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.
- Background: PubMed 23458548Carriere 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.
- Background: PubMed 12916575Gross 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.
- Background: PubMed 16004657Henry 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.
- Background: PubMed 7042457Kabat-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.
- Background: PubMed 29791865Luna 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.
- Background: PubMed 28512859Pogrebtsova 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.
- BackgroundAng 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
- BackgroundBerná JC, Limiñana Gras RM. The genie in a bottle. the CREA test, questions and creativity. introduction to special theme
- BackgroundCabello 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
- BackgroundElisondo 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
- Limesurvey open source survey toolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The CRAFT program (adapted due to COVID-19) and The MBSR program (adapted due to COVID-19) in people with Psychological Distress and Life Stress, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Five Facets Mindfulness Questionnaire (time frame: Baseline, 4 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392869, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.