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Effectiveness evaluation of a 5-week mindfulness-based self-leadership training (MBSL-Training) with healthcare students: a multicentre randomised longitudinal study

Effectiveness evaluation of a 5-week mindfulness-based self-leadership training (MBSL-Training) with healthcare students: a multicentre randomised longitudinal study - EEMBSLTHS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034404
Enrollment
300
Registered
2024-09-10
Start date
2025-02-18
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress and mental well-being

Interventions

Group 1: Intervention groups at three locations: 5-week guided MBSL-training to reduce stress and increase mental well-being. Frequency: 2h/week for five weeks. Afterwards, students continue to train

Sponsors

Zürcher Hochschule für angewandte Wissenschaften, Departement angewandte Psychologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Valid declaration of consent

Exclusion criteria

Exclusion criteria: Invalid declaration of consent

Design outcomes

Primary

MeasureTime frame
For both groups (intervention and control group) there are the following measurement times: Baseline measurement (T0): Before the start of the study Post-measurement (T1): After the 5-week MBSL-Training Post-measurement (T2): after the 7-week training with the individualised MBSL- training plan Follow-up measurement (T3): after a further 12 weeks (6 months after the baseline measurement) At all measurement points, data on experienced stress, mental well-being, self-leadership and mindfulness are collected using validated measuring instruments. The measuring instruments used are Perceived stress scale (PSS-10) The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Mindfulness: Five Facet Mindfulness Questionnaire German (FFMQ-D) Revised Self-Leadership Questionnaire German (RSLQ-D) --> primary outcome: total score PSS-10 at T1

Secondary

MeasureTime frame
At the T2 measurement points, data is also collected using validated measurement instruments on expected results, training fidelity, acceptance, feasibility and appropriateness (--> implementation strategies). The measurement instruments used are the Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Fidelity (Frequency of training attendance and training at home) Workshop appraisal scale (WASC) In addition, qualitative data on the implementation of the MBSL- training at home is collected between measurement points T2 and T3. This is done by means of a reflection report with the following questions Which exercises were chosen? What helped/hindered the implementation in everyday life? What would you want to change? Is such training important for students in healthcare professions? And why yes, why no? How does this type of training affect interprofessional collaboration? --> secondary outcome: total score PSS-10 at T2 and total score WEMWBS at T1 and T2 The primary outcome will be analyzed using a linear mixed-effects model including treatment group and baseline PSS-10 score as fixed effects. Study center will be included to account for the multicenter design. The treatment effect will be estimated as the adjusted mean difference between groups using a two-sided significance level of 0.05. Secondary outcomes will be analyzed using analogous models and considered exploratory. All analyses will adhere to the ITT principle. Linear mixed-effects models provide valid inference under the Missing at Random (MAR) assumption. No complete-case analyses will be performed. Patterns and extent of missing data will be reported descriptively.

Countries

Switzerland

Contacts

Public ContactMichael Zirkler

ZHAW, Departement angewandte Psychologie

michael.zirkler@zhaw.ch+41 58 934 83 26

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026