Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students

NCT ID: NCT03712319

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2019-01-01

Brief Summary

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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

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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

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Students

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Single-blind. The type of intervention (presence-based, app or waiting list) can not be masked neither for the participant nor for the intervention provider. Thus, the masking only applies to the assessor of the results.

Study Groups

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Group 1: App.

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.

Group Type EXPERIMENTAL

REM Volver a casa

Intervention Type BEHAVIORAL

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).

Group 2: MBSR.

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.

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Stress Reduction program

Intervention Type BEHAVIORAL

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.

Group 3: Waiting list.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REM Volver a casa

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).

Intervention Type BEHAVIORAL

Mindfulness-Based Stress Reduction program

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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REM, app MBSR

Eligibility Criteria

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Inclusion Criteria

* Student of Medicine, Nutrition, Psychology or Nursing.
* Ability to read and understand Spanish language.
* Signature of Informed Consent.

Exclusion Criteria

* Previous MBSR or anorther standardized Mindfulness training.
* Inability to read or understand Spanish language.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Madrid

OTHER

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Bayón, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz. Universidad Autónoma de Madrid

Beatriz Rodríguez Vega, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz. Universidad Autónoma de Madrid

Locations

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Hospital Universitario La Paz [La Paz University Hospital]

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 27535243 (View on PubMed)

Barbosa 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.

Reference Type BACKGROUND
PMID: 23823667 (View on PubMed)

Krusche 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.

Reference Type BACKGROUND
PMID: 24293203 (View on PubMed)

Lamothe 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.

Reference Type BACKGROUND
PMID: 26860797 (View on PubMed)

Kirby 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.

Reference Type BACKGROUND
PMID: 27664071 (View on PubMed)

Related Links

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Other Identifiers

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DHAERMP

Identifier Type: -

Identifier Source: org_study_id

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