Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students
- Conditions
- Students
- Interventions
- Behavioral: REM Volver a casaBehavioral: Mindfulness-Based Stress Reduction program
- Registration Number
- NCT03712319
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- Student of Medicine, Nutrition, Psychology or Nursing.
- Ability to read and understand Spanish language.
- Signature of Informed Consent.
- Previous MBSR or anorther standardized Mindfulness training.
- Inability to read or understand Spanish language.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: App. REM Volver a casa 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 2: MBSR. Mindfulness-Based Stress Reduction program 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.
- Primary Outcome Measures
Name Time Method State-trait anxiety 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.
- Secondary Outcome Measures
Name Time Method Self-compassion From baseline to 16 weeks 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).
State-Trait Anger From baseline to 16 weeks 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.
Mindfulness From baseline to 16 weeks 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 ).
Empathy From baseline to 16 weeks 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).
Expectancy of improvement Pre-intervention questionnaire 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.
Depression From baseline to 16 weeks 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.
Autonomous motivation Pre-intervention questionnaire 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.
State-Trait Anxiety From baseline to 16 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.
Trial Locations
- Locations (1)
Hospital Universitario La Paz [La Paz University Hospital]
🇪🇸Madrid, Spain