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

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).

Study Overview

• Status: Recruiting
• Conditions: Subjective Stress
• Intervention / Treatment: Other: Mindfulness course

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcela Winkler, Dr; Phone Number: 2073 +49711 8181; Email: marcela.winkler@rbk.de

Study Locations

• Germany
  • Baden Würtenberg
    • Stuttgart, Baden Würtenberg, Germany, 70341
      • Recruiting
      • Robert-Bosch-Krankenhaus
      • Contact: Marcela Winkler, Dr; Phone Number: 2073 0711-8101; Email: marcela.winkler@rbk.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulnes "Healthy Under Stress" Stress Management Program; Participants will have two-hour sessions for 8 weeks.	Other: Mindfulness course; Online or in presence Information on Mindfulness, healthy diet and exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After 8 Weeks (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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.	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.	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.	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.	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.	After 8 Weeks (end of intervention)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
• Investigators: Study Director: Marcela Winkler, Dr, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Healthy Lifestyle
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Subjective Stress
• Other Study ID Numbers: S00822-NIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No