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

NCT07255313 | Recruiting

• 1 other identifier: 24-12325-BO
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Resilience; Stress; Burnout; Burnout Syndrome

Keywords

stress resilience; work health promotion; burnout prevention; mental well-being; occupational stress; healthcare workers; Mind-Body Medicine; complementary medicine; nutrition; employee health; participatory research; randomized controlled trial; workplace intervention; self-care strategies; occupational health management; Self-Efficacy and Stress Resistance; nutrition and mental health

Outcome Measures

Primary Outcomes (1)

• Stress Resilience

  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.

  Week 10

Secondary Outcomes (16)

• Burnout

  Week 10

• Stress Coping

  Week 10

• Stress Symptoms

  Week 10

• Physical Resilience

  Week 10

• Mental Well-Being

  Week 10

Other Outcomes (21)

• Mindfulness

  Baseline

• Subjective Workload

  Baseline

• Ability to Change

  Baseline

Study Arms (2)

SOULFOOD Programme

EXPERIMENTAL

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 techniques. Each week covers a specific theme, such as mindful eating, emotional and stress regulation in the workplace, mindfulness, communication skills and social connections.

Behavioral: SOULFOOD Programme

Waitlist Control Group

NO INTERVENTION

Participants in the waitlist control group do not receive any intervention during the 26-week waiting period. After this period, they will receive the same course program as the active intervention group.

Interventions

SOULFOOD Programme BEHAVIORAL

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 techniques. Each week covers a specific theme, such as mindful eating, emotional and stress regulation in the workplace, mindfulness, communication skills and social connections.

SOULFOOD Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Center for Integrative Medicine and Planetary Health, University Hospital Essen

Essen, 45145, Germany

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological; Psychological Well-Being; Occupational Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction; Occupational Diseases

Study Officials

• Gustav Dobos, Prof. MD

  University of Duisburg-Essen

  STUDY DIRECTOR

• Heidemarie Haller, PhD

  University of Duisburg-Essen

  PRINCIPAL INVESTIGATOR

• Larissa Setzer

  University of Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larissa Setzer

CONTACT

+49 201 723-77386; larissa.setzer@uk-essen.de

Heidemarie Dr. rer. medic. Haller

CONTACT

+4920172377384; heidemarie.haller@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Intervention and control group with waitlist design

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)