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

Not Applicable
Not yet recruiting
Conditions
Subjective Stress
Interventions
Other: Mindfulness course
Registration Number
NCT06431087
Lead Sponsor
University Hospital Tuebingen
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).

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
120
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Mindfulnes "Healthy Under Stress" Stress Management ProgramMindfulness courseParticipants will have two-hour sessions for 8 weeks.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Hospital Anxiety and Depression ScaleFollow-up 3 Moths after the 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).

Perceived Stress ScaleFollow-up 3 Moths after the 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).

International Physical Activity QuestionnaireFollow-up 3 Moths after the 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).

Mindful Attention and Awareness ScaleFollow-up 3 Moths after the 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.

Quality of life QuestionnaireFollow-up 3 Moths after the 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).

Mediterranean Diet Adhrence ScreenerFollow-up 3 Moths after the 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.

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.

Trial Locations

Locations (1)

Robert-Bosch-Krankenhaus

🇩🇪

Stuttgart, Baden Würtenberg, Germany

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