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

Subjective Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431087
• Other study ID #: S00822-NIM
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 8, 2024
• Est. completion date: February 28, 2028

Study information

• Verified date: May 2024
• Source: University Hospital Tuebingen
• Contact: Marcela Winkler, Dr
• Phone: +49711 8181
• Email: marcela.winkler[@]rbk.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 28, 2028
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Subjective Stress

Intervention

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

Locations

Country	Name	City	State
Germany	Robert-Bosch-Krankenhaus	Stuttgart	Baden Würtenberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Robert Bosch Hospital Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Follow-up 3 Moths after the intervention
Secondary	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).	After 8 Weeks (end of intervention)
Secondary	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).	Follow-up 3 Moths after the intervention
Secondary	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).	After 8 Weeks (end of intervention)
Secondary	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).	Follow-up 3 Moths after the intervention
Secondary	International Physical Activity Questionnaire	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).	After 8 Weeks (end of intervention)
Secondary	International Physical Activity Questionnaire	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).	Follow-up 3 Moths after the intervention
Secondary	Mediterranean Diet Adhrence Screener	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.	After 8 Weeks (end of intervention)
Secondary	Mediterranean Diet Adhrence Screener	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.	Follow-up 3 Moths after the intervention
Secondary	Mindful Attention and Awareness Scale	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.	After 8 Weeks (end of intervention)
Secondary	Mindful Attention and Awareness Scale	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.	Follow-up 3 Moths after the intervention
Secondary	Safety evaluation	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.	After 8 Weeks (end of intervention)