跳至主要内容
临床试验/NCT07255313
NCT07255313招募中不适用

Strengthening Psycho-physiological and Psycho-emotional Competencies in Healthcare Workers Through Mind Body Medicine and Nutrition: A Randomized Controlled Trial

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
252
试验地点
2
主要终点
Stress Resilience

研究概览

简要总结

This is a randomized controlled trial aiming to develop and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers at University Medicine Essen using a participatory research design (including a steering committee composed of hospital staff, needs assessment through focus groups, and pilot testing). The intervention combines mind-body medicine techniques, complementary medicine self-care strategies, and psycho-biotic nutrition. If successful, the program will be integrated into routine workplace health management and serve as a model for other healthcare institutions.

详细描述

This participatory research study at University Medicine Essen aims to develop, implement, and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers. Increasing stress, staff shortages, and high rates of sick leave negatively impact both employees and patient care, making a comprehensive and sustainable health program essential. To ensure the intervention meets employees' needs, the study is guided by a steering committee consisting of hospital staff from various departments, including occupational health management, sustainability management, reintegration services, and the nonscientific staff council. A preliminary needs assessment will be conducted through focus groups, allowing employees to provide input on key aspects such as session format, duration, and content. Furthermore, the intervention design will be tested in a pilot phase to ensure the design is feasible and accepted by the participants.

The intervention will be a multimodal program combining mind-body medicine techniques, complementary self-care, and psycho-biotic nutrition to enhance stress resilience and overall health. Mind-body medicine includes mindfulness and stress management techniques, while complementary self-care will focus on easily applicable techniques from Traditional European Medicine (TEM) and Traditional Indian Medicine (TIM). Psycho-biotic nutrition, based on the connection between gut health and mental well-being, aims to support emotional and cognitive health through dietary changes. The study will use a randomized controlled trial design, comparing an intervention group with a waitlist control group to evaluate effectiveness.

Beyond individual benefits, the study also seeks to identify workplace-level improvements by promoting mindfulness among employees and leadership regarding structural stressors. This includes optimizing communication, understanding one's thoughts and emotions, and improving workplace policies such as break structures to better support employee well-being. By integrating feedback from the needs assessment and the pilot phase, the study aims to develop a sustainable and evidence-based health program that can be incorporated into routine workplace health management at University Medicine Essen. If successful, the intervention will serve as a model for other healthcare institutions and may be implemented more broadly within the healthcare sector.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older
  • Employees of University Medicine Essen
  • Moderate resilience of ≤ 144 points on the RS-25
  • Willingness to practice at home and keep a practice diary

排除标准

  • Insufficient German language skills
  • Pregnancy and breastfeeding
  • Severe comorbid mental disorders (e.g., substance use disorder, major depression) or other severe comorbid somatic diseases (e.g., oncological disease without remission, severe pre-existing cardiovascular disease, organ failure, other severe neurological disorders)
  • Planned or ongoing pension application (e.g., disability pension, occupational disability, reduced earning capacity, severe disability)
  • Concurrent participation in other clinical intervention studies

结局指标

主要结局

Stress Resilience

时间窗: Week 10

Measured with the Resilience Scale (RS-25), a 25-item self-report instrument assessing personal competence and acceptance of life on one sum scale. Higher scores indicate greater resilience.

次要结局

  • Burnout(Week 26)
  • Stress Coping(Week 10)
  • Stress Symptoms(Week 26)
  • Physical Resilience(Week 26)
  • Mental Well-Being(Week 26)
  • Psychological Distress(Week 10)
  • Health Behaviour Change(Week 26)
  • Adverse Events(From enrollment to the end of treatment at week 10)
  • Stress Resilience(Week 26)
  • Stress Coping Strategies(Week 26)
  • Psychological distress(Week 26)
  • Burnout(Week 10)
  • Stress Symptoms(Week 10)
  • Physical Resilience(Week 10)
  • Mental Well-Being(Week 10)
  • Health Behaviour Change(Week 10)
  • Burnout(Week 26)
  • Stress Coping(Week 10)
  • Stress Symptoms(Week 26)
  • Physical Resilience(Week 26)
  • Mental Well-Being(Week 26)
  • Psychological Distress(Week 10)
  • Health Behaviour Change(Week 26)
  • Adverse Events(From enrollment to the end of treatment at week 10)
  • Stress Resilience(Week 26)
  • Stress Coping Strategies(Week 26)
  • Psychological distress(Week 26)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heidemarie Haller

Director of Research

Universität Duisburg-Essen

研究点 (2)

Loading locations...

相似试验