Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06431087

Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: 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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert-Bosch-Krankenhaus

Stuttgart, Baden Würtenberg, 70341, Germany

Location status: Recruiting

Location contact

Marcela Winkler, Dr

CONTACT

[email protected]

0711-8101 ext. 2073

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Mindfulness course

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: Follow-up 3 Moths after the 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).

  2. Hospital Anxiety and Depression Scale

    Time frame: After 8 Weeks (end of intervention)

    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).

  3. Hospital Anxiety and Depression Scale

    Time frame: Follow-up 3 Moths after the intervention

    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).

  4. Quality of life Questionnaire

    Time frame: After 8 Weeks (end of intervention)

    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).

  5. Quality of life Questionnaire

    Time frame: Follow-up 3 Moths after the intervention

    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).

  6. International Physical Activity Questionnaire

    Time frame: After 8 Weeks (end of intervention)

    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).

  7. International Physical Activity Questionnaire

    Time frame: Follow-up 3 Moths after the intervention

    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).

  8. Mediterranean Diet Adhrence Screener

    Time frame: After 8 Weeks (end of intervention)

    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.

  9. Mediterranean Diet Adhrence Screener

    Time frame: Follow-up 3 Moths after the intervention

    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.

  10. Mindful Attention and Awareness Scale

    Time frame: After 8 Weeks (end of intervention)

    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.

  11. Mindful Attention and Awareness Scale

    Time frame: Follow-up 3 Moths after the intervention

    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.

  12. Safety evaluation

    Time frame: After 8 Weeks (end of intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcela Winkler, Dr

CONTACT

[email protected]

+49711 8181 ext. 2073

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Registry information

Official study title

Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 28, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.