Clinical trial NCT03712319: Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students
Official title: Mindfulness for Healthcare Students: Smartphone App or Face-to-face Group? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Students
Keywords: mindfulness
mobile application
students
anxiety
depression
self-compassion
empathy
burnout
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Madrid
First posted: 2018-10-19
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: State-trait anxiety
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: State-Trait Anger
timeFrame: From baseline to 8 weeks
measure: Mindfulness
timeFrame: From baseline to 8 weeks
measure: Self-compassion
timeFrame: From baseline to 8 weeks
measure: Empathy
timeFrame: From baseline to 8 weeks
measure: Depression
timeFrame: From baseline to 8 weeks
measure: Expectancy of improvement
timeFrame: Pre-intervention questionnaire
measure: Autonomous motivation
timeFrame: Pre-intervention questionnaire
measure: State-Trait Anxiety
timeFrame: From baseline to 16 weeks
measure: Mindfulness
timeFrame: From baseline to 16 weeks
measure: State-Trait Anger
timeFrame: From baseline to 16 weeks
measure: Self-compassion
timeFrame: From baseline to 16 weeks
measure: Empathy
timeFrame: From baseline to 16 weeks
measure: Depression
timeFrame: From baseline to 16 weeks
Other outcomes:
measure: Practice time
timeFrame: 8 weeks
measure: Drop-out rate
timeFrame: From baseline to 8 weeks
measure: Drop-out rate
timeFrame: From baseline to 16 weeks
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz [La Paz University Hospital]
Study officials:
affiliation: Hospital Universitario La Paz. Universidad Autónoma de Madrid
name: Carmen Bayón, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz. Universidad Autónoma de Madrid
name: Beatriz Rodríguez Vega, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.