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Recruiting NCT07255313

Strengthening Health Literacy in Healthcare Workers Through Mind Body Medicine and Nutrition

No phase Interventional Stress Resilience Stress Burnout Burnout Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SOULFOOD Programme.
Who it may be relevant to
Registry conditions: Stress Resilience, Stress, Burnout, Burnout Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral SOULFOOD Programme
    This arm is a 10-week multimodal program designed to enhance resilience and health competencies. Participants engage in structured weekly intervention sessions lasting 2 hours and homework activities. These sessions are delivered in person, with flexible scheduling to accommodate work schedules. The intervention focuses on mind-body medicine, complementary medicine and nutrition. Core components include psycho-biotic nutrition, movement, relaxation techniques, and complementary self-care techniq

Primary outcome measures

  • Stress Resilience [Time frame: Week 10]
Secondary outcome measures (12)
  • Burnout [Time frame: Week 10]
  • Stress Coping [Time frame: Week 10]
  • Stress Symptoms [Time frame: Week 10]
  • Physical Resilience [Time frame: Week 10]
  • Mental Well-Being [Time frame: Week 10]
  • Psychological Distress [Time frame: Week 10]
  • Health Behaviour Change [Time frame: Week 10]
  • Adverse Events [Time frame: From enrollment to the end of treatment at week 10]
  • Stress Resilience [Time frame: Week 26]
  • Burnout [Time frame: Week 26]
  • Stress Coping Strategies [Time frame: Week 26]
  • Stress Symptoms [Time frame: Week 26]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Germany · 1 center
  • Center for Integrative Medicine and Planetary Health, University Hospital Essen — Essen

Identifiers

NCT: NCT07255313 · 24-12325-BO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗