Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students

NCT03712319 | Completed

• 1 other identifier: DHAERMP
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Students

Keywords

mindfulness; mobile application; students; anxiety; depression; self-compassion; empathy; burnout

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 8 weeks

Secondary Outcomes (13)

• State-Trait Anger

  From baseline to 8 weeks

• Mindfulness

  From baseline to 8 weeks

• Self-compassion

  From baseline to 8 weeks

• Empathy

  From baseline to 8 weeks

• Depression

  From baseline to 8 weeks

Other Outcomes (3)

• Practice time

  8 weeks

• Drop-out rate

  From baseline to 8 weeks

• Drop-out rate

  From baseline to 16 weeks

Study Arms (3)

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.

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.

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.

Interventions

REM Volver a casa 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).

Also known as: REM, app

Group 1: App.

Mindfulness-Based Stress Reduction program 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.

Also known as: MBSR

Group 2: MBSR.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous MBSR or anorther standardized Mindfulness training.
• Inability to read or understand Spanish language.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Universidad Autonoma de Madrid: collaborator

Study Sites (1)

Hospital Universitario La Paz [La Paz University Hospital]

Madrid, 28046, Spain

Location

Related Publications (5)

• 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.

  PMID: 27535243 BACKGROUND

• 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.

  PMID: 23823667 BACKGROUND

• 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.

  PMID: 24293203 BACKGROUND

• 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.

  PMID: 26860797 BACKGROUND

• 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.

  PMID: 27664071 BACKGROUND

Related Links

• App webpage

MeSH Terms

Conditions

Anxiety Disorders; Depression; Burnout, Psychological

Interventions

Sleep, REM; Amyloid

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress, Psychological

Intervention Hierarchy (Ancestors)

Sleep Stages; Sleep; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Carmen Bayón, Doctor

  Hospital Universitario La Paz. Universidad Autónoma de Madrid

  PRINCIPAL INVESTIGATOR

• Beatriz Rodríguez Vega, Doctor

  Hospital Universitario La Paz. Universidad Autónoma de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: October 19, 2018
• Study Start: September 13, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 8, 2019

Record last verified: 2018-05

Locations

ES (1)