StudentsNCT03712319
Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students
A study testing REM Volver a casa and Mindfulness-Based Stress Reduction program in people with Students, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The main purpose of this study is to compare the efficacy of a mindfulness-based training app ('REM Volver a Casa') versus a regular, presence-based program (MBSR) on the reduction of anxiety and other factors related to the physician-patient relationship, in healthcare grade students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Students
- What is being tested?
- REM Volver a casa and Mindfulness-Based Stress Reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 13 Sep 2016to 1 Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student of Medicine, Nutrition, Psychology or Nursing.
- Ability to read and understand Spanish language.
- Signature of Informed Consent.
Who cannot join
- Previous MBSR or anorther standardized Mindfulness training.
- Inability to read or understand Spanish language.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario La Paz [La Paz University Hospital]
Madrid, 28046
About this study
Official title: Mindfulness for Healthcare Students: Smartphone App or Face-to-face Group? A Randomized Controlled Trial
The main purpose of this study is to compare the efficacy of a mindfulness-based training app ('REM Volver a Casa') versus a regular, presence-based program (MBSR) on the reduction of anxiety and other factors related to the physician-patient relationship, in healthcare grade students.
Read the detailed description
Healthcare students suffer from higher levels of anxiety and depression than the general population. It compromises not only their mental health, but also the quality of care provided. Aptitudes such as empathy and self-compassion are essential to improve this deficit and overcome the well-known burnout syndrome.
Mindfulness-Based Stress Reduction (MBSR) program has proven to be an effective intervention for lowering stress in numerous studies. However, this intervention asks for a significant degree of personal involvement, thus the number of dropouts is often reported as a problem. New technologies might allow users to adapt training to their personal schedules.
The present randomized trial aims to compare the efficacy of a mindfulness-based training delivered through a mobile application ('REM Volver a Casa'), a presence-based program (MBSR), and a control group in healthcare grade students.
- Conditions
- Students
- Being tested
- REM Volver a casa, Mindfulness-Based Stress Reduction program
- Keywords
- mindfulness, mobile application, students, anxiety, depression, self-compassion, empathy, burnout
- Medical subject headings
- Anxiety Disorders, Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REM Volver a casaBehavioural
Also called REM, app
The program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. REM is an application available for Android and iOs. It proposes a guided training through 8 stages. They contain video recordings with explanations about the fundamentals of mindfulness, audio recordings that guide practices of mindfulness, as well as suggestions to bring it into everyday life. They can be used whenever it suits the user. The app counts the progress of each participant, as well as the mood changes according to a distress scale before and after performing a formal practice. The app has been designed following the international recommendations for the development of apps (MARS guide).
Mindfulness-Based Stress Reduction programBehavioural
Also called MBSR
The program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. MBSR is a program developed at the University of Massachusetts Medical Center in the 1970s by Professor Jon Kabat-Zinn. MBSR uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful. In recent years, meditation has been the subject of clinical research, that suggests it may have beneficial effects, including stress reduction, relaxation, and improvements to quality of life. While MBSR has its roots in spiritual teachings, the program itself is secular. The session is delivered to a small group of people by a certified instructor during two and a half hours, every week.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: App. | Experimental | Participants use application "REM Volver a casa" on their cell phones during 8 weeks. Codes are provided to the students in order to unlock the different stages of the training free of charge. The application provides short videos and audios for training. Students practice on their own, in accordance with the instruction of completing a stage a week. Receives: Behavioral: REM Volver a casa |
| Group 2: MBSR. | Active comparator | Participants attend a presence-based training during 8 weeks. The Mindfulness-Based Stress Reduction program involves a session of two and a half hours each week. Receives: Behavioral: Mindfulness-Based Stress Reduction program |
| Group 3: Waiting list. | No intervention | Participants do not receive any intervention during the study. At the end of the study (16 weeks), they are provided with the codes so they can unlock the app and use it like participants from Group 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-trait anxiety
Post-intervention changes in State-Trait Anxiety Inventory (STAI) for each of the arms. It is a self-administered questionnaire which includes two subscales assessing state and trait anxiety. Each of them consists of 20 Likert items ranging 0-3. Lower values mean better outcomes.
Measured: From baseline to 8 weeks
Secondary outcomes (13)
State-Trait Anger
Post-intervention changes in State-Trait Anger Expression Inventory (STAXI) for each of the arms. It is a self-administered questionnaire that evaluates the experience, expression and control of anger, in adolescents and adults. The STAXI-2 Inventory consists of six scales and five subscales with 49 items in total.
Measured: From baseline to 8 weeks
Mindfulness
Post-intervention changes in Five Facet Mindfulness Questionnaire (FFMQ) for each of the arms. FFMQ, by Baer, Smith, Hopkins, Krietemeyer and Toney (2006): 39 items that evaluate five facets on which the mindfulness ability is based: observe, describe, act with conscience, equanimity and not reactivity. Each item is scored according to a Likert scale that ranges from 1 (never) to 5 (very often). It has a high internal consistency, as well as a high predictive validity of the aspects that conform the Mindfulness construct (Baer, 2006). Validated in Spanish (Cebolla et al., 2012 ).
Measured: From baseline to 8 weeks
Self-compassion
Post-intervention changes in dimensions of Neff Self-compassion Scale (SCS) for each of the arms. SCS (Neff, 2003), validated in Spanish in 2014 (García-Campayo et al., 2014 ): 26 items that evaluate six facets on which the self-compassion skill is based: kindness with oneself, judgment towards oneself, shared humanity, loneliness, mindfulness and overidentification. Each item is scored according to a Likert scale that ranges from 1 (almost never) to 5 (almost always).
Measured: From baseline to 8 weeks
Empathy
Post-intervention changes in global Empathy questionnaire score (Jefferson Scale of Physician Empathy, JSE) for each of the arms. It includes three subscales: compassionate care, taking perspective and "standing on the patient's boots". Higher total values indicate greater empathy. It is valid in the Spanish population (Alcorta Garza et al., 2005).
Measured: From baseline to 8 weeks
Depression
Post-intervention changes in Beck Depression Inventory (BDI-II) for each of the arms. Self-administered questionnaire of 21 items that measures the severity of depression in adults and adolescents over 13 years of age. It is one of the most used questionnaires within the field of psychology when measuring the severity of depression.
Measured: From baseline to 8 weeks
Expectancy of improvement
Pre-intervention measure through the 0-100% Expectancy of Improvement Scale, derived from Credibility / Expectancy Questionnaire (CEQ, Devilly \& Borkovec), which has proven to be a reliable predictor of results in multiple studies and populations. The CEQ questionnaire is the measure of credibility / expectations most used in research in psychotherapy. The scale is graduated in 10 options, corresponding higher score to greater expectation of improvement.
Measured: Pre-intervention questionnaire
Autonomous motivation
Pre-intervention measure through the Self-Regulation Questionnaire (SRQ-L, Williams, GC, \& Deci, 2000). It is given a version of this self-administered questionnaire, which provides subscales of autonomous, controlled motivation and an autonomous regulation index (RAI, which is the subtraction of the previous). It has been previously used in medical students showing evidence of criterion validity with other measures. The questionnaire includes 13 reasons for participation in the intervention, in which the participant must score from 0 to 7 on a Likert scale if each statement is true for their case.
Measured: Pre-intervention questionnaire
State-Trait Anxiety
Post-intervention changes in State-Trait Anxiety Inventory (STAI) for each of the arms. It is a self-administered questionnaire which includes two subscales assessing state and trait anxiety. Each of them consists of 20 Likert items ranging 0-3. Lower values mean better outcomes.
Measured: From baseline to 16 weeks
Mindfulness
Post-intervention changes in Five Facet Mindfulness Questionnaire (FFMQ) for each of the arms. FFMQ, by Baer, Smith, Hopkins, Krietemeyer and Toney (2006): 39 items that evaluate five facets on which the mindfulness ability is based: observe, describe, act with conscience, equanimity and not reactivity. Each item is scored according to a Likert scale that ranges from 1 (never) to 5 (very often). It has a high internal consistency, as well as a high predictive validity of the aspects that conform the Mindfulness construct (Baer, 2006). Validated in Spanish (Cebolla et al., 2012 ).
Measured: From baseline to 16 weeks
State-Trait Anger
Post-intervention changes in State-Trait Anger Expression Inventory (STAXI) for each of the arms. It is a self-administered questionnaire that evaluates the experience, expression and control of anger, in adolescents and adults. The STAXI-2 Inventory consists of six scales and five subscales with 49 items in total.
Measured: From baseline to 16 weeks
Self-compassion
Post-intervention changes in dimensions of Neff Self-compassion Scale (SCS) for each of the arms. SCS (Neff, 2003), validated in Spanish in 2014 (García-Campayo et al., 2014 ): 26 items that evaluate six facets on which the self-compassion skill is based: kindness with oneself, judgment towards oneself, shared humanity, loneliness, mindfulness and overidentification. Each item is scored according to a Likert scale that ranges from 1 (almost never) to 5 (almost always).
Measured: From baseline to 16 weeks
Empathy
Post-intervention changes in global Empathy questionnaire score (Jefferson Scale of Physician Empathy, JSE) for each of the arms. It includes three subscales: compassionate care, taking perspective and "standing on the patient's boots". Higher total values indicate greater empathy. It is valid in the Spanish population (Alcorta Garza et al., 2005).
Measured: From baseline to 16 weeks
Depression
Post-intervention changes in Beck Depression Inventory (BDI-II) for each of the arms. Self-administered questionnaire of 21 items that measures the severity of depression in adults and adolescents over 13 years of age. It is one of the most used questionnaires within the field of psychology when measuring the severity of depression.
Measured: From baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start13 Sep 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StudentsStudies 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
- Randomized, prospective, controlled and single-blind trial of 16 weeks. Students of Medicine, Nutrition, Psychology and Nursing are randomly assigned to the app group, the presential-based MBSR program or a waiting list. Three evaluations take place: pre-intervention, at 8 weeks (post-intervention) and at 16 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Responsible party
- Sponsor
- Investigators
- Carmen Bayón, Doctor, Principal investigator, Hospital Universitario La Paz. Universidad Autónoma de MadridBeatriz Rodríguez Vega, Doctor, Principal investigator, Hospital Universitario La Paz. Universidad Autónoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712319
- Sponsor's protocol ID
- DHAERMP
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared from PI on request
Publications
Aherne D, Farrant K, Hickey L, Hickey E, McGrath L, McGrath D. Mindfulness based stress reduction for medical students: optimising student satisfaction and engagement. BMC Med Educ. 2016 Aug 18;16(1):209. doi: 10.1186/s12909-016-0728-8.
PubMed 27535243Barbosa P, Raymond G, Zlotnick C, Wilk J, Toomey R 3rd, Mitchell J 3rd. Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Educ Health (Abingdon). 2013 Jan-Apr;26(1):9-14. doi: 10.4103/1357-6283.112794.
PubMed 23823667Krusche A, Cyhlarova E, Williams JM. Mindfulness online: an evaluation of the feasibility of a web-based mindfulness course for stress, anxiety and depression. BMJ Open. 2013 Nov 29;3(11):e003498. doi: 10.1136/bmjopen-2013-003498.
PubMed 24293203Lamothe M, Rondeau E, Malboeuf-Hurtubise C, Duval M, Sultan S. Outcomes of MBSR or MBSR-based interventions in health care providers: A systematic review with a focus on empathy and emotional competencies. Complement Ther Med. 2016 Feb;24:19-28. doi: 10.1016/j.ctim.2015.11.001. Epub 2015 Nov 27.
PubMed 26860797Kirby JN. Compassion interventions: The programmes, the evidence, and implications for research and practice. Psychol Psychother. 2017 Sep;90(3):432-455. doi: 10.1111/papt.12104. Epub 2016 Sep 24.
PubMed 27664071
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Healthcare Students: Smartphone App or Face-to-face Group? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03712319
- Acronym / sponsor ID
- DHAERMP
- Conditions
- Students
- Keywords
- mindfulness, mobile application, students, anxiety, depression, self-compassion, empathy, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 Oct 2018 (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 main purpose of this study is to compare the efficacy of a mindfulness-based training app ('REM Volver a Casa') versus a regular, presence-based program (MBSR) on the reduction of anxiety and other factors related to the physician-patient relationship, in healthcare grade students.
Detailed description
Healthcare students suffer from higher levels of anxiety and depression than the general population. It compromises not only their mental health, but also the quality of care provided. Aptitudes such as empathy and self-compassion are essential to improve this deficit and overcome the well-known burnout syndrome.
Mindfulness-Based Stress Reduction (MBSR) program has proven to be an effective intervention for lowering stress in numerous studies. However, this intervention asks for a significant degree of personal involvement, thus the number of dropouts is often reported as a problem. New technologies might allow users to adapt training to their personal schedules.
The present randomized trial aims to compare the efficacy of a mindfulness-based training delivered through a mobile application ('REM Volver a Casa'), a presence-based program (MBSR), and a control group in healthcare grade students.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, prospective, controlled and single-blind trial of 16 weeks. Students of Medicine, Nutrition, Psychology and Nursing are randomly assigned to the app group, the presential-based MBSR program or a waiting list. Three evaluations take place: pre-intervention, at 8 weeks (post-intervention) and at 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group 1: App. | Experimental | Behavioral: REM Volver a casaParticipants use application "REM Volver a casa" on their cell phones during 8 weeks. Codes are provided to the students in order to unlock the different stages of the training free of charge. The application provides short videos and audios for training. Students practice on their own, in accordance with the instruction of completing a stage a week. |
| Group 2: MBSR. | Active comparator | Behavioral: Mindfulness-Based Stress Reduction programParticipants attend a presence-based training during 8 weeks. The Mindfulness-Based Stress Reduction program involves a session of two and a half hours each week. |
| Group 3: Waiting list. | No intervention | –Participants do not receive any intervention during the study. At the end of the study (16 weeks), they are provided with the codes so they can unlock the app and use it like participants from Group 1. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Student of Medicine, Nutrition, Psychology or Nursing.
- Ability to read and understand Spanish language.
- Signature of Informed Consent.
Key exclusion criteria (2 listed)
- Previous MBSR or anorther standardized Mindfulness training.
- Inability to read or understand Spanish language.
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 |
|---|---|---|
| REM Volver a casaAlso: REM, appThe program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. REM is an application available for Android and iOs. It proposes a guided training through 8 stages. They contain video recordings with explanations about the fundamentals of mindfulness, audio recordings that guide practices of mindfulness, as well as suggestions to bring it into everyday life. They can be used whenever it suits the user. The app counts the progress of each participant, as well as the mood changes according to a distress scale before and after performing a formal practice. The app has been designed following the international recommendations for the development of apps (MARS guide). | Behavioural | Group 1: App. |
| Mindfulness-Based Stress Reduction programAlso: MBSRThe program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. MBSR is a program developed at the University of Massachusetts Medical Center in the 1970s by Professor Jon Kabat-Zinn. MBSR uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful. In recent years, meditation has been the subject of clinical research, that suggests it may have beneficial effects, including stress reduction, relaxation, and improvements to quality of life. While MBSR has its roots in spiritual teachings, the program itself is secular. The session is delivered to a small group of people by a certified instructor during two and a half hours, every week. | Behavioural | Group 2: MBSR. |
Primary outcome
State-trait anxiety
Time frame: From baseline to 8 weeks
Post-intervention changes in State-Trait Anxiety Inventory (STAI) for each of the arms. It is a self-administered questionnaire which includes two subscales assessing state and trait anxiety. Each of them consists of 20 Likert items ranging 0-3. Lower values mean better outcomes.
13 secondary outcomes
State-Trait Anger
Time frame: From baseline to 8 weeks
Mindfulness
Time frame: From baseline to 8 weeks
Self-compassion
Time frame: From baseline to 8 weeks
Empathy
Time frame: From baseline to 8 weeks
Depression
Time frame: From baseline to 8 weeks
Expectancy of improvement
Time frame: Pre-intervention questionnaire
Autonomous motivation
Time frame: Pre-intervention questionnaire
State-Trait Anxiety
Time frame: From baseline to 16 weeks
Mindfulness
Time frame: From baseline to 16 weeks
State-Trait Anger
Time frame: From baseline to 16 weeks
Self-compassion
Time frame: From baseline to 16 weeks
Empathy
Time frame: From baseline to 16 weeks
Depression
Time frame: From baseline to 16 weeks
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 8 Aug 2019.
- Background: PubMed 27535243Aherne D, Farrant K, Hickey L, Hickey E, McGrath L, McGrath D. Mindfulness based stress reduction for medical students: optimising student satisfaction and engagement. BMC Med Educ. 2016 Aug 18;16(1):209. doi: 10.1186/s12909-016-0728-8.
- Background: PubMed 23823667Barbosa P, Raymond G, Zlotnick C, Wilk J, Toomey R 3rd, Mitchell J 3rd. Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Educ Health (Abingdon). 2013 Jan-Apr;26(1):9-14. doi: 10.4103/1357-6283.112794.
- Background: PubMed 24293203Krusche A, Cyhlarova E, Williams JM. Mindfulness online: an evaluation of the feasibility of a web-based mindfulness course for stress, anxiety and depression. BMJ Open. 2013 Nov 29;3(11):e003498. doi: 10.1136/bmjopen-2013-003498.
- Background: PubMed 26860797Lamothe M, Rondeau E, Malboeuf-Hurtubise C, Duval M, Sultan S. Outcomes of MBSR or MBSR-based interventions in health care providers: A systematic review with a focus on empathy and emotional competencies. Complement Ther Med. 2016 Feb;24:19-28. doi: 10.1016/j.ctim.2015.11.001. Epub 2015 Nov 27.
- Background: PubMed 27664071Kirby JN. Compassion interventions: The programmes, the evidence, and implications for research and practice. Psychol Psychother. 2017 Sep;90(3):432-455. doi: 10.1111/papt.12104. Epub 2016 Sep 24.
- App webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD will be shared from PI on request
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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.
Carmen Bayón, Doctor principal investigator
Hospital Universitario La Paz. Universidad Autónoma de Madrid
Beatriz Rodríguez Vega, Doctor principal investigator
Hospital Universitario La Paz. Universidad Autónoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REM Volver a casa and Mindfulness-Based Stress Reduction program in people with Students, run by Instituto de Investigación Hospital Universitario La Paz 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 8 Aug 2019. 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?
State-trait anxiety (time frame: From baseline to 8 weeks). 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 NCT03712319, which also lists 5 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 8 Aug 2019.