Mindfulness for Healthcare Students: Smartphone App or Face-to-face Group? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- State-trait anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student of Medicine, Nutrition, Psychology or Nursing.
- •Ability to read and understand Spanish language.
- •Signature of Informed Consent.
排除标准
- •Previous MBSR or anorther standardized Mindfulness training.
- •Inability to read or understand Spanish language.
研究组 & 干预措施
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.
干预措施: REM Volver a casa (Behavioral)
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.
干预措施: Mindfulness-Based Stress Reduction program (Behavioral)
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.
结局指标
主要结局
State-trait anxiety
时间窗: 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.
次要结局
- Self-compassion(From baseline to 16 weeks)
- State-Trait Anger(From baseline to 16 weeks)
- Mindfulness(From baseline to 16 weeks)
- Empathy(From baseline to 16 weeks)
- Expectancy of improvement(Pre-intervention questionnaire)
- Depression(From baseline to 16 weeks)
- Autonomous motivation(Pre-intervention questionnaire)
- State-Trait Anxiety(From baseline to 16 weeks)