Clinical trial NCT06431087: Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study
Official title: Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subjective Stress
Keywords: Mindfulness
Healthy Lifestyle
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
First posted: 2024-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Center, an Arm, prospective intervention study.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: After 8 Weeks (end of intervention)
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Follow-up 3 Moths after the intervention
measure: Hospital Anxiety and Depression Scale
timeFrame: After 8 Weeks (end of intervention)
measure: Hospital Anxiety and Depression Scale
timeFrame: Follow-up 3 Moths after the intervention
measure: Quality of life Questionnaire
timeFrame: After 8 Weeks (end of intervention)
measure: Quality of life Questionnaire
timeFrame: Follow-up 3 Moths after the intervention
measure: International Physical Activity Questionnaire
timeFrame: After 8 Weeks (end of intervention)
measure: International Physical Activity Questionnaire
timeFrame: Follow-up 3 Moths after the intervention
measure: Mediterranean Diet Adhrence Screener
timeFrame: After 8 Weeks (end of intervention)
measure: Mediterranean Diet Adhrence Screener
timeFrame: Follow-up 3 Moths after the intervention
measure: Mindful Attention and Awareness Scale
timeFrame: After 8 Weeks (end of intervention)
measure: Mindful Attention and Awareness Scale
timeFrame: Follow-up 3 Moths after the intervention
measure: Safety evaluation
timeFrame: After 8 Weeks (end of intervention)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
state: Baden Würtenberg
Study officials:
affiliation: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Marcela Winkler, Dr
role: STUDY_DIRECTOR
References: