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A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

Kuhlmann SM, Bürger A, Esser G, Hammerle F - Trials (2015)

Bottom Line: Compared to the general population, medical students are at a greater risk of developing a psychological disorder.Effect sizes will be calculated using partial η-square values.Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group.

View Article: PubMed Central - PubMed

Affiliation: Department for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. sophie.kuhlmann@unimedizin-mainz.de.

ABSTRACT

Background: Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind).

Methods/design: This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values.

Discussion: Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis.

Trial registration: This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

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Related in: MedlinePlus

‘Study design’.
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Fig1: ‘Study design’.

Mentions: This is a prospective, randomized, controlled trial, involving four assessment time points (baseline, post-intervention, one-year follow-up and five-year follow-up) and three groups (experimental treatment, standard treatment and control without treatment). Participants are a self-selected group that will be assigned randomly to either the experimental, standard or control group. The longitudinal design will allow the evaluation of the short- and long-term effects of the intervention. Figure 1 shows the overall design of this project. All study procedures, written information and consent forms received approval from the local ethics committee (Landesärztekammer Rheinland-Pfalz, file number: 837.380.13/9065-F) and the University Medical Center data protection official. To report this randomized controlled trial we made use of the CONSORT guidelines [52,53].Figure 1


A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

Kuhlmann SM, Bürger A, Esser G, Hammerle F - Trials (2015)

‘Study design’.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4328883&req=5

Fig1: ‘Study design’.
Mentions: This is a prospective, randomized, controlled trial, involving four assessment time points (baseline, post-intervention, one-year follow-up and five-year follow-up) and three groups (experimental treatment, standard treatment and control without treatment). Participants are a self-selected group that will be assigned randomly to either the experimental, standard or control group. The longitudinal design will allow the evaluation of the short- and long-term effects of the intervention. Figure 1 shows the overall design of this project. All study procedures, written information and consent forms received approval from the local ethics committee (Landesärztekammer Rheinland-Pfalz, file number: 837.380.13/9065-F) and the University Medical Center data protection official. To report this randomized controlled trial we made use of the CONSORT guidelines [52,53].Figure 1

Bottom Line: Compared to the general population, medical students are at a greater risk of developing a psychological disorder.Effect sizes will be calculated using partial η-square values.Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group.

View Article: PubMed Central - PubMed

Affiliation: Department for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. sophie.kuhlmann@unimedizin-mainz.de.

ABSTRACT

Background: Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind).

Methods/design: This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values.

Discussion: Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis.

Trial registration: This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Show MeSH
Related in: MedlinePlus