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Recruiting NCT06431087

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

No phase Interventional Subjective Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness course.
Who it may be relevant to
Registry conditions: Subjective Stress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Perceived Stress Scale [Time frame: After 8 Weeks (end of intervention)]
Secondary outcome measures (12)
  • Perceived Stress Scale [Time frame: Follow-up 3 Moths after the intervention]
  • Hospital Anxiety and Depression Scale [Time frame: After 8 Weeks (end of intervention)]
  • Hospital Anxiety and Depression Scale [Time frame: Follow-up 3 Moths after the intervention]
  • Quality of life Questionnaire [Time frame: After 8 Weeks (end of intervention)]
  • Quality of life Questionnaire [Time frame: Follow-up 3 Moths after the intervention]
  • International Physical Activity Questionnaire [Time frame: After 8 Weeks (end of intervention)]
  • International Physical Activity Questionnaire [Time frame: Follow-up 3 Moths after the intervention]
  • Mediterranean Diet Adhrence Screener [Time frame: After 8 Weeks (end of intervention)]
  • Mediterranean Diet Adhrence Screener [Time frame: Follow-up 3 Moths after the intervention]
  • Mindful Attention and Awareness Scale [Time frame: After 8 Weeks (end of intervention)]
  • Mindful Attention and Awareness Scale [Time frame: Follow-up 3 Moths after the intervention]
  • Safety evaluation [Time frame: After 8 Weeks (end of intervention)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • Robert-Bosch-Krankenhaus — Stuttgart

Identifiers

NCT: NCT06431087 · S00822-NIM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗