Subjective StressNCT06431087
Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study
A study testing Mindfulness course in people with Subjective Stress, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjective Stress
- What is being tested?
- Mindfulness course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2024to 28 Feb 2028
- 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
- Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.
- Informed consent.
Who cannot join
- Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study.
- Participation in other clinical studies with behavioral, psychological or complementary medical interventions.
- Insufficient knowledge of the German language.
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
Robert-Bosch-Krankenhaus
Stuttgart, Baden Würtenberg, 70341
Marcela Winkler, Dr, 0711-8101 ext. 2073, marcela.winkler@rbk.de
About this study
Official title: Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study
Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS).
Read the detailed description
After baseline (t0), all participant will receive the following intervention:
The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network.
t1 (at the end of the program).
t2 (3 months after t0).
- Conditions
- Subjective Stress
- Being tested
- Mindfulness course
- Keywords
- Mindfulness, Healthy Lifestyle
- Medical subject headings
- Subjective Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness courseOther
Online or in presence Information on Mindfulness, healthy diet and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulnes "Healthy Under Stress" Stress Management Program | Experimental | Participants will have two-hour sessions for 8 weeks. Receives: Other: Mindfulness course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often).
Measured: After 8 Weeks (end of intervention)
Secondary outcomes (12)
Perceived Stress Scale
The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often).
Measured: Follow-up 3 Moths after the intervention
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment).
Measured: After 8 Weeks (end of intervention)
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment).
Measured: Follow-up 3 Moths after the intervention
Quality of life Questionnaire
Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability).
Measured: After 8 Weeks (end of intervention)
Quality of life Questionnaire
Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability).
Measured: Follow-up 3 Moths after the intervention
International Physical Activity Questionnaire
The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET).
Measured: After 8 Weeks (end of intervention)
International Physical Activity Questionnaire
The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET).
Measured: Follow-up 3 Moths after the intervention
Mediterranean Diet Adhrence Screener
The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD.
Measured: After 8 Weeks (end of intervention)
Mediterranean Diet Adhrence Screener
The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD.
Measured: Follow-up 3 Moths after the intervention
Mindful Attention and Awareness Scale
The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences.
Measured: After 8 Weeks (end of intervention)
Mindful Attention and Awareness Scale
The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences.
Measured: Follow-up 3 Moths after the intervention
Safety evaluation
In order to evaluate the safety of the intervention, unforeseen events are documented. For this purpose participants are explicitly asked about the occurrence of these.
Measured: After 8 Weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start8 Jul 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective StressStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Center, an Arm, prospective intervention study.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Responsible party
- Sponsor
- Investigators
- Marcela Winkler, Dr, Study director, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431087
- Sponsor's protocol ID
- S00822-NIM
- Status last verified
- Mar 2026
- First submitted
- 16 May 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT06431087
- Acronym / sponsor ID
- S00822-NIM
- Conditions
- Subjective Stress
- Keywords
- Mindfulness, Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 28 May 2024 (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.
Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS).
Detailed description
After baseline (t0), all participant will receive the following intervention:
The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network.
t1 (at the end of the program).
t2 (3 months after t0).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Center, an Arm, prospective intervention study.
| Arm | Type | Receives |
|---|---|---|
| Mindfulnes "Healthy Under Stress" Stress Management Program | Experimental | Other: Mindfulness courseParticipants will have two-hour sessions for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.
- Informed consent.
Key exclusion criteria (3 listed)
- Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study.
- Participation in other clinical studies with behavioral, psychological or complementary medical interventions.
- Insufficient knowledge of the German language.
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 |
|---|---|---|
| Mindfulness courseOnline or in presence Information on Mindfulness, healthy diet and exercise. | Other | Mindfulnes "Healthy Under Stress" Stress Management Program |
Primary outcome
Perceived Stress Scale
Time frame: After 8 Weeks (end of intervention)
The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often).
12 secondary outcomes
Perceived Stress Scale
Time frame: Follow-up 3 Moths after the intervention
Hospital Anxiety and Depression Scale
Time frame: After 8 Weeks (end of intervention)
Hospital Anxiety and Depression Scale
Time frame: Follow-up 3 Moths after the intervention
Quality of life Questionnaire
Time frame: After 8 Weeks (end of intervention)
Quality of life Questionnaire
Time frame: Follow-up 3 Moths after the intervention
International Physical Activity Questionnaire
Time frame: After 8 Weeks (end of intervention)
International Physical Activity Questionnaire
Time frame: Follow-up 3 Moths after the intervention
Mediterranean Diet Adhrence Screener
Time frame: After 8 Weeks (end of intervention)
Mediterranean Diet Adhrence Screener
Time frame: Follow-up 3 Moths after the intervention
Mindful Attention and Awareness Scale
Time frame: After 8 Weeks (end of intervention)
Mindful Attention and Awareness Scale
Time frame: Follow-up 3 Moths after the intervention
Safety evaluation
Time frame: After 8 Weeks (end of intervention)
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 12 Mar 2026.
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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.
Marcela Winkler, Dr study director
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness course in people with Subjective Stress, run by University Hospital Tuebingen 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 2 inclusion and 3 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 12 Mar 2026. 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 Marcela Winkler, Dr (+49711 8181 ext. 2073, marcela.winkler@rbk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: After 8 Weeks (end of intervention)). 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 12 Mar 2026.