Studying the Effect of a Mindfulness-based Intervention on Medical Students

NCT05567991 | Completed

• 1 other identifier: 1Med_a
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Well-being

Keywords

mindfulness; well-being; medical students; distress; resilience; emotion regulation

Outcome Measures

Primary Outcomes (3)

• change in perceived stress

  Perceived stress outcome will be measured through the Perceived Stress Score (PSS) questionnaire. PSS can range from 0 to 40 with higher scores indicating higher perceived stress. The scores obtained from the questionnaire is a measure of the psychological investigated outcome.

  Assessed at baseline (to) and after the intervention (12 weeks)

• Change in state anxiety

  The state anxiety outcome will be measured through the State Anxiety Inventory (STAI-X1) questionnaire. Score ranges from 0-63 with higher scores indicating higher state anxiety levels. The scores obtained from the questionnaire is a measure of the psychological investigated outcome.

  Assessed at baseline (to) and after the intervention (12 weeks)

• Change in mental well-being

  The well-being outcome will be measured through the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) questionnaire. Higher scores indicate mental well-being. PSS can range from 14 to 70 with higher scores indicating higher well-being. The scores obtained from the questionnaire is a measure of the psychological investigated outcome.

  Assessed at baseline (to) and after the intervention (12 weeks)

Secondary Outcomes (5)

• Change in positive affect

  Assessed at baseline (t0) and after the intervention (12 weeks)

• Change in resilience

  Assessed at baseline (t0) and after the intervention (12 weeks)

• Change in mind-wondering

  Assessed at baseline (t0) and after the intervention (12 weeks)

• Change in emotion regulation

  Assessed at baseline (t0) and after the intervention (12 weeks)

• Change in attentional control

  Assessed at baseline (t0) and after the intervention (12 weeks)

Study Arms (2)

Treatment group

EXPERIMENTAL

The individuals assigned to the treatment group attend the training sessions and were asked to complete all the questionnaires at both time points

Behavioral: Comprehensive Mindulness-Based Intervention (C-MBI)

Passive Control Group

NO INTERVENTION

The individuals assigned to the passive control group did not attend any training session and were only asked to complete the same questionnaires as the treatment group at both time points. Participants in the control group were asked not to practice meditation during the period of the study for an unbiased comparison with the intervention group.

Interventions

Comprehensive Mindulness-Based Intervention (C-MBI) BEHAVIORAL

C-MBI, was administer online via Zoom and included: 10 Integral Meditation classes lasting approximately 35 minutes each, given twice a week (Monday and Wednesday); 10 minutes of yoga exercises focused on breathing and posture before each IM class; and dietary advice. Regarding this latter, the participants received via email a document which entailed non-mandatory dietary suggestions to promote healthy nutrition, sleep and stress-relief. An online lecture held by the nutritionist with a question-and-answer format was also organized. The degree to which to follow this advice was left to the discretion of each participant. The core of our intervention was represented by the IM training, that is a MBI intervention, that simultaneously uses breathing, focusing attention, releasing of physical tensions, thoughts and feeling sensations through internal senses and imagery, allowing a quick relaxation and more deeply a physical, energetic, and spiritual well-being.

Treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead
• Università degli Studi di Brescia: collaborator

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Psychological Well-Being; Emotional Regulation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: October 5, 2022
• Study Start: January 23, 2021
• Primary Completion: July 3, 2021
• Study Completion: October 2, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-09

Locations

IT (1)