Clinical trial NCT05567991: Studying the Effect of a Mindfulness-based Intervention on Medical Students
Official title: Improving Stress Management, Anxiety, and Mental Well-being in Medical Students Through an Online Mindfulness-Based Intervention: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Well-being
Keywords: mindfulness
well-being
medical students
distress
resilience
emotion regulation
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
First posted: 2022-10-05
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the scientific literature, the responsibilities and pressures of medical school and residency are widely known for putting a strain on medical student's personal wellbeing, leading to high rates of anxiety, depression, burnout, and emotional discomfort. In this study investigators aim at evaluating the hypotheses on the effectiveness of a comprehensive Mindfulness-Based Intervention (MBI) in reducing this load. The intervention comprised 12 Integral Meditation (IM) classes, advice on health dietary behavior and brief yoga session. The effect of the intervention on medical students from Italian universities will be evaluated by performing a randomized trial through the analysis of nine questionnaires used for measuring the psychological outcomes of interest.

Detailed description: In the scientific literature, the responsibilities and pressures of medical school and residency are widely known for putting a strain on medical student's personal wellbeing, leading to high rates of anxiety, depression, burnout, and emotional discomfort. Academic pressure, financial concerns, workload, sleep deprivation, drugs abuse, exposure to patients' suffering and fatalities are among the numerous causes linked to such a decrease in mental well-being in medical studies setting. The so-called hidden curriculum is also a factor considered in medical education. It is based on implicit teaching that includes moral and ethical values among medical education. When this teaching goes in a negative direction such as cynicism towards patients, future career, or competition with colleagues, can become one of the causes that influences medical students in terms of psychological distress and burnout. Additionally, psychological distress among students has been claimed to have a negative impact on their academic performance, and on the increased thought of dropping out medical school. This also leads to academic dishonesty, which includes problems such as plagiarism, cheating, pseudoscience and falsification, and to alcohol and substance addiction. Medical students suffering from psychological distress have a more generally lack of empathy.

To make matters worse, the recent Covid-19 pandemic has placed an additional burden on students around the world Aware of this situation, medical students are using different coping strategies to reduce distress. While taking drugs and substances such as tranquilizers, have negative or side effects, taking social support and physical activity have positive effects only. Mindfulness-Based Interventions (MBI) is an effective complement to these strategies.

Mindfulness is a state of pre-reflexive consciousness that can be put in contrast with other modalities in which the person is constantly engaged in overthinking, obsessing about the past, fantasizing and worrying about the future or engaged in compulsive or automatic behavior without acknowledging it. The benefits of such a state of being is well-known in literature, so that MBIs are getting popular in medical education, to such an extent that many medical schools around the world are beginning to acknowledge mindfulness as a helpful practice for their students, residents, and staff with the goal of also increase patient care quality.

Hence to develop and apply easily accessible and low-cost strategies to diminish the levels of stress of medical students is crucial for their academic performance and professional development.

The aim of the present study was to assess the efficacy of a comprehensive MBI, entirely administered online, consisting of a mindfulness-based practice, called Integral Meditation (IM), dietary advice, and brief yoga sessions, in two cohorts of Italian medical students randomized to intervention or control group. The primary hypothesis is that participants in the intervention group would report a decrease of perceived stress and state anxiety and an increase of mental well-being. The secondary hypothesis investigators tested was that participants in the intervention group would report higher scores on different measures of positive affect, resilience, and emotion regulation and attentional control. The investigated outcomes were measured using nine self-report questionnaires administered online to both groups before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Must have digital advice and an Internet connection to complete the assessment and to attend the classes
* Must understand Italian language

Exclusion Criteria:

* Severe anxiety or depression
* Severe mental illness (e.g., hypomania or psychotic episode)
* Any other serious mental or physical health problem

Primary outcomes:
measure: change in perceived stress
timeFrame: Assessed at baseline (to) and after the intervention (12 weeks)
measure: Change in state anxiety
timeFrame: Assessed at baseline (to) and after the intervention (12 weeks)
measure: Change in mental well-being
timeFrame: Assessed at baseline (to) and after the intervention (12 weeks)
Secondary outcomes:
measure: Change in positive affect
timeFrame: Assessed at baseline (t0) and after the intervention (12 weeks)
measure: Change in resilience
timeFrame: Assessed at baseline (t0) and after the intervention (12 weeks)
measure: Change in mind-wondering
timeFrame: Assessed at baseline (t0) and after the intervention (12 weeks)
measure: Change in emotion regulation
timeFrame: Assessed at baseline (t0) and after the intervention (12 weeks)
measure: Change in attentional control
timeFrame: Assessed at baseline (t0) and after the intervention (12 weeks)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
References: