Mental Well-beingNCT05567991
Studying the Effect of a Mindfulness-based Intervention on Medical Students
A study testing Comprehensive Mindulness-Based Intervention (C-MBI) in people with Mental Well-being, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being
- What is being tested?
- Comprehensive Mindulness-Based Intervention (C-MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2021to 2 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have digital advice and an Internet connection to complete the assessment and to attend the classes
- Must understand Italian language
Who cannot join
- Severe anxiety or depression
- Severe mental illness (e.g., hypomania or psychotic episode)
- Any other serious mental or physical health problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Stress Management, Anxiety, and Mental Well-being in Medical Students Through an Online Mindfulness-Based Intervention: a Randomized Study
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.
Read the 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.
- Conditions
- Mental Well-being
- Being tested
- Comprehensive Mindulness-Based Intervention (C-MBI)
- Keywords
- mindfulness, well-being, medical students, distress, resilience, emotion regulation
- Medical subject headings
- Psychological Well-Being, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Mindulness-Based Intervention (C-MBI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline (to) and after the intervention (12 weeks)
Secondary outcomes (5)
Change in positive affect
Positive affect outcome through Positive and Negative Affect Schedule (PANAS) measuring both Positive affect (PA) and Negative affect (NA). Scores range 10-50 for both. Higher PA score indicates more positive affect, while lower NA score less negative affect.
Measured: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in resilience
Resilience through the Resilience Scale (RS-14) that ranges 14-98, higher scores indicate a higher level of resilience.
Measured: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in mind-wondering
Mind-wondering outcome through Mind Wandering Spontaneous (MW-S) that ranges 4-28, higher score indicating a higher tendency of mind wandering in daily life.
Measured: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in emotion regulation
Emotion regulation outcome through Difficulties in Emotion Regulation Scale (DERS). Scores range 33-165, higher score indicates higher difficulties in emotion regulation
Measured: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in attentional control
Attention control outcome through Attention Control (AC-S and AC-W) Scales that range 4-20 and 4-40, higher score indicating higher attentional distraction and difficulties in attentional shifting.
Measured: Assessed at baseline (t0) and after the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start23 Jan 2021
- Primary completion3 Jul 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Responsible party
- Principal investigator, Teresa Fazia, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567991
- Sponsor's protocol ID
- 1Med_a
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Stress Management, Anxiety, and Mental Well-being in Medical Students Through an Online Mindfulness-Based Intervention: a Randomized Study
- ClinicalTrials.gov ID
- NCT05567991
- Acronym / sponsor ID
- 1Med_a
- Conditions
- Mental Well-being
- Keywords
- mindfulness, well-being, medical students, distress, resilience, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Comprehensive Mindulness-Based Intervention (C-MBI)The individuals assigned to the treatment group attend the training sessions and were asked to complete all the questionnaires at both time points |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have digital advice and an Internet connection to complete the assessment and to attend the classes
- Must understand Italian language
Key exclusion criteria (3 listed)
- Severe anxiety or depression
- Severe mental illness (e.g., hypomania or psychotic episode)
- Any other serious mental or physical health problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Mindulness-Based Intervention (C-MBI)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. | Behavioural | Treatment group |
Primary outcome
change in perceived stress
Time frame: Assessed at baseline (to) and after the intervention (12 weeks)
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.
Change in state anxiety
Time frame: Assessed at baseline (to) and after the intervention (12 weeks)
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.
Change in mental well-being
Time frame: Assessed at baseline (to) and after the intervention (12 weeks)
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.
5 secondary outcomes
Change in positive affect
Time frame: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in resilience
Time frame: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in mind-wondering
Time frame: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in emotion regulation
Time frame: Assessed at baseline (t0) and after the intervention (12 weeks)
Change in attentional control
Time frame: Assessed at baseline (t0) and after the intervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Mindulness-Based Intervention (C-MBI) in people with Mental Well-being, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in perceived stress (time frame: Assessed at baseline (to) and after the intervention (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.