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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Informed consent.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Mindfulness course

    Other intervention

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Mindfulnes "Healthy Under Stress" Stress Management ProgramExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
After 8 Weeks (end of intervention)

Secondary 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).

Time frame
Follow-up 3 Moths after the intervention
2

Hospital Anxiety and Depression Scale

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).

Time frame
After 8 Weeks (end of intervention)
3

Hospital Anxiety and Depression Scale

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).

Time frame
Follow-up 3 Moths after the intervention
4

Quality of life Questionnaire

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).

Time frame
After 8 Weeks (end of intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Tuebingen

Lead sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Collaborator