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RecruitingNCT06431087Updated Mar 12, 2026

Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study

An interventional study of Mindfulness course in Subjective Stress, sponsored by University Hospital Tuebingen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Subjective Stress

Keywords

  • Mindfulness
  • Healthy Lifestyle
03

In context

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.
  • Informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Mindfulnes "Healthy Under Stress" Stress Management Program

    Participants will have two-hour sessions for 8 weeks.

    Other: Mindfulness course

Interventions

  • OtherMindfulness course

    Online or in presence Information on Mindfulness, healthy diet and exercise.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: After 8 Weeks (end of intervention)

Secondary outcomes

  1. 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).

    Time frame: Follow-up 3 Moths after the intervention

  2. 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).

    Time frame: After 8 Weeks (end of intervention)

  3. 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).

    Time frame: Follow-up 3 Moths after the intervention

  4. 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).

    Time frame: After 8 Weeks (end of intervention)

  5. 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).

    Time frame: Follow-up 3 Moths after the intervention

  6. 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).

    Time frame: After 8 Weeks (end of intervention)

  7. 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).

    Time frame: Follow-up 3 Moths after the intervention

  8. 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.

    Time frame: After 8 Weeks (end of intervention)

  9. 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.

    Time frame: Follow-up 3 Moths after the intervention

  10. 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.

    Time frame: After 8 Weeks (end of intervention)

  11. 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.

    Time frame: Follow-up 3 Moths after the intervention

  12. 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.

    Time frame: After 8 Weeks (end of intervention)

07

Study locations

1 of 1 sites recruiting
  • Robert-Bosch-Krankenhaus
    Stuttgart, Baden Würtenberg 70341, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06431087
Lead sponsor
University Hospital Tuebingen
Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Responsible party
Sponsor
First posted
May 28, 2024
Start date
Jul 8, 2024
Primary completion
Aug 30, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Mar 12, 2026

Study contacts

Marcela Winkler, Dr
Contact
marcela.winkler@rbk.de
+49711 8181 ext. 2073
Marcela Winkler, Dr
study director · Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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