Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06431087
Enrollment
120
Registered
2024-05-28
Start date
2024-07-08
Completion date
2028-02-28
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective Stress

Keywords

Mindfulness, Healthy Lifestyle

Brief 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).

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).

Interventions

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

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Single-Center, an Arm, prospective intervention study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress ScaleAfter 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

MeasureTime frameDescription
Perceived Stress ScaleFollow-up 3 Moths after the interventionThe 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).
Hospital Anxiety and Depression ScaleAfter 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).
Quality of life QuestionnaireAfter 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).
International Physical Activity QuestionnaireAfter 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).
Mediterranean Diet Adhrence ScreenerAfter 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.
Mindful Attention and Awareness ScaleAfter 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.
Safety evaluationAfter 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.

Countries

Germany

Contacts

CONTACTMarcela Winkler, Dr
marcela.winkler@rbk.de+49711 8181
STUDY_DIRECTORMarcela Winkler, Dr

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026