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Stress ResilienceSOULFOODNCT07255313

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

A study testing SOULFOOD Programme in people with Stress Resilience and Stress, run by Universität Duisburg-Essen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Resilience, Stress, Burnout
What is being tested?
SOULFOOD Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteGermany
Study dates
1 Dec 2025to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heidemarie Dr. rer. medic. Haller contact

+4920172377384

heidemarie.haller@uk-essen.de

Germany1 site, 1 recruiting
  • Center for Integrative Medicine and Planetary Health, University Hospital Essen

    Essen, 45145

    Larissa Setzer, +49 201 723-77386, larissa.setzer@uk-essen.de

    Heidemarie Dr. rer. medic. Haller

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
SOULFOOD Programme
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
Medical subject headings
Burnout, Psychological, Psychological Well-Being, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOULFOOD ProgrammeBehavioural

    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.

Study groups in NCT07255313
Study groupRoleWhat they receive
SOULFOOD ProgrammeExperimentalThis 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.
Receives: Behavioral: SOULFOOD Programme
Waitlist Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 10

Secondary outcomes (16)
  1. Burnout

    Assessed using the Maslach Burnout Inventory - Human Services Survey (MBI-HSS), a 22-item scale measuring emotional exhaustion, depersonalization, and personal accomplishment (three subscales). Higher exhaustion and depersonalization scores with lower personal accomplishment scores indicate a higher risk of burnout.

    Measured: Week 10

  2. Stress Coping

    Measured using the "Coping" subscale of the Stress- und Coping-Inventory (SCI-COPE), a 20-item self-report scale assessing five coping strategies on five subscales: positive thinking, active coping, social support, religion, and substance use (four items each). Higher scores indicate better coping skills.

    Measured: Week 10

  3. Stress Symptoms

    Measured using the "Symptoms"-subscale of the Stress- und Coping-Inventory (SCI-SYMPT), a 13-item self-report scale assessing physical and psychological stress symptoms (e.g., sleep disturbances, concentration issues). Higher scores indicate greater symptom burden on one sum scale.

    Measured: Week 10

  4. Physical Resilience

    Assessed with the subscale "Physical Resilience" of the Questionnaire for Assessing Health Behavior (FEG). It consists of five items rated on a Likert scale (1 = does not apply at all to 5 = fully applies), covering aspects such as perceived robustness, recovery after illness, and endurance in stressful situations. The mean of all items is calculated, with higher mean values indicating greater resilience.

    Measured: Week 10

  5. Mental Well-Being

    Measured with the World Health Organization (WHO-5) Well-Being Index, a self-report instrument measuring mental well-being. It consists of five statements summed up to one total scale. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.

    Measured: Week 10

  6. Psychological Distress

    Psychological distress is assessed using the total score of the Patient Health Questionnaire-4 (PHQ-4), a brief self-report screening tool for anxiety and depressive symptoms. The PHQ-4 consists of four items rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 12. Higher scores indicate greater psychological distress.

    Measured: Week 10

  7. Health Behaviour Change

    This outcome measures participants' self-reported engagement in five domains of health-promoting behavior: relaxation, physical activity, breathing, nutrition, and complementary self-care. Assessment is conducted using the "Temple of Health," a pictorial tool consisting of five pillars representing these domains. Each pillar is 10 cm in height and serves as an visual analogue scale, with the bottom representing "I do not engage in this behavior" and the top representing "I fully engage in this behavior." Participants are instructed to color or draw on each pillar to indicate their perceived level of engagement.

    Measured: Week 10

  8. Adverse Events

    Adverse events are documented using participant self-report sheets provided at the beginning of the intervention period. Participants are instructed to record any physical or psychological complaints, discomfort, or other unexpected events that occur during the course of the study. Each entry includes the date, a brief description of the event, perceived severity, and whether the event is ongoing. The collected sheets are reviewed by the study team to identify, classify, and evaluate adverse events according to their frequency, severity, and potential relation to the intervention.

    Measured: From enrollment to the end of treatment at week 10

  9. 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.

    Measured: Week 26

  10. Burnout

    Assessed using the Maslach Burnout Inventory - Human Services Survey (MBI-HSS), a 22-item scale measuring emotional exhaustion, depersonalization, and personal accomplishment (three subscales). Higher exhaustion and depersonalization scores with lower personal accomplishment scores indicate a higher risk of burnout.

    Measured: Week 26

  11. Stress Coping Strategies

    Measured using the "Coping"-subscale of the Stress- und Coping-Inventory (SCI-COPE), a 20-item self-report scale assessing five different coping strategies on five subscales: positive thinking, active coping, social support, religion and substance use with four items each. Higher scores indicate better coping skills.

    Measured: Week 26

  12. Stress Symptoms

    Measured using the "Symptoms"-subscale of the Stress- und Coping-Inventory (SCI-SYMPT), a 13-item self-report scale assessing physical and psychological stress symptoms (e.g., sleep disturbances, concentration issues). Higher scores indicate greater symptom burden on one sum scale.

    Measured: Week 26

  13. Physical Resilience

    Assessed with the subscale "Physical Resilience" of the Questionnaire for Assessing Health Behavior (FEG). It consists of five items rated on a Likert scale (1 = does not apply at all to 5 = fully applies), covering aspects such as perceived robustness, recovery after illness, and endurance in stressful situations. The mean of all items is calculated, with higher mean values indicating greater resilience.

    Measured: Week 26

  14. Mental Well-Being

    Measured with the World Health Organization (WHO-5) Well-Being Index, a self-report instrument measuring mental well-being. It consists of five statements summed up to one total scale. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.

    Measured: Week 26

  15. Psychological distress

    Psychological distress is assessed using the total score of the Patient Health Questionnaire-4 (PHQ-4), a brief self-report screening tool for anxiety and depressive symptoms. The PHQ-4 consists of four items rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 12. Higher scores indicate greater psychological distress.

    Measured: Week 26

  16. Health Behaviour Change

    This outcome measures participants' self-reported engagement in five domains of health-promoting behavior: relaxation, physical activity, breathing, nutrition, and complementary self-care. Assessment is conducted using the "Temple of Health," a pictorial tool consisting of five pillars representing these domains. Each pillar is 10 cm in height and serves as an visual analogue scale, with the bottom representing "I do not engage in this behavior" and the top representing "I fully engage in this behavior." Participants are instructed to color or draw on each pillar to indicate their perceived level of engagement.

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention and control group with waitlist design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255313
Sponsor's protocol ID
24-12325-BO
Acronym
SOULFOOD
Status last verified
Dec 2025
First submitted
17 Nov 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD), including demographic information, baseline characteristics, outcome measures, and analyzable datasets used for primary and secondary endpoint analyses, will be made available to qualified researchers upon reasonable request and following review and approval by the study team.

Questions about this trial

What is this clinical trial studying?

A study testing SOULFOOD Programme in people with Stress Resilience and Stress, run by Universität Duisburg-Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Larissa Setzer (+49 201 723-77386, larissa.setzer@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress Resilience (time frame: Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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