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

NCT06431087 | Recruiting DMC

• 1 other identifier: S00822-NIM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Subjective Stress

Keywords

Mindfulness; Healthy Lifestyle

Outcome Measures

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).

  After 8 Weeks (end of intervention)

Secondary Outcomes (12)

• Perceived Stress Scale

  Follow-up 3 Moths after the intervention

• Hospital Anxiety and Depression Scale

  After 8 Weeks (end of intervention)

• Hospital Anxiety and Depression Scale

  Follow-up 3 Moths after the intervention

• Quality of life Questionnaire

  After 8 Weeks (end of intervention)

• Quality of life Questionnaire

  Follow-up 3 Moths after the intervention

Study Arms (1)

Mindfulnes "Healthy Under Stress" Stress Management Program

EXPERIMENTAL

Participants will have two-hour sessions for 8 weeks.

Other: Mindfulness course

Interventions

Mindfulness course OTHER

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

Mindfulnes "Healthy Under Stress" Stress Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): collaborator

Study Sites (1)

Robert-Bosch-Krankenhaus

Stuttgart, Baden Würtenberg, 70341, Germany

RECRUITING

MeSH Terms

Conditions

Subjective Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Marcela Winkler, Dr

  Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

  STUDY DIRECTOR

Central Study Contacts

Marcela Winkler, Dr

CONTACT

+49711 8181; marcela.winkler@rbk.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-Center, an Arm, prospective intervention study.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (1)