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.
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
- Type of treatment
- Lifestyle or therapy 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.
Germany1 site, 1 recruiting
- 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
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.
- Conditions
- Stress Resilience, Stress, Burnout, Burnout Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted1 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, University of Duisburg-EssenHeidemarie Haller, PhD, Principal investigator, University of Duisburg-EssenLarissa Setzer, Principal investigator, University of Duisburg-Essen
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Psycho-physiological and Psycho-emotional Competencies in Healthcare Workers Through Mind Body Medicine and Nutrition: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07255313
- Acronym / sponsor ID
- SOULFOOD / 24-12325-BO
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control group with waitlist design
| Arm | Type | Receives |
|---|---|---|
| SOULFOOD Programme | Experimental | Behavioral: SOULFOOD ProgrammeThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOULFOOD ProgrammeThis 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. | Behavioural | SOULFOOD Programme |
Primary outcome
Stress Resilience
Time frame: 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.
16 secondary outcomes
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
Physical Resilience
Time frame: Week 26
Mental Well-Being
Time frame: Week 26
Psychological distress
Time frame: Week 26
Health Behaviour Change
Time frame: Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustav Dobos, Prof. MD study director
University of Duisburg-Essen
Heidemarie Haller, PhD principal investigator
University of Duisburg-Essen
Larissa Setzer principal investigator
University of Duisburg-Essen
1 site in 1 country: see every site and its status.
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.