## Protocol Section
### Identification Module
**NCT ID:** NCT06431087

**Acronym:** GIS

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

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

#### Organization Study ID Info
**ID:** S00822-NIM
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Tuebingen
### Status Module
#### Completion Date
**Date:** 2028-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Robert Bosch Hospital Stuttgart

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Tuebingen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Subjective Stress

**Keywords:**

- Mindfulness

- Healthy Lifestyle

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Single-Center, an Arm, prospective intervention study.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will have two-hour sessions for 8 weeks.

**Intervention Names:**

- Other: Mindfulness course

**Label:** Mindfulnes "Healthy Under Stress" Stress Management Program

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindfulnes "Healthy Under Stress" Stress Management Program

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

**Name:** Mindfulness course

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Perceived Stress Scale

**Time Frame:** After 8 Weeks (end of intervention)

#### Secondary Outcomes

**Description:** 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).

**Measure:** Perceived Stress Scale

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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).

**Measure:** Hospital Anxiety and Depression Scale

**Time Frame:** After 8 Weeks (end of intervention)

**Description:** 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).

**Measure:** Hospital Anxiety and Depression Scale

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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).

**Measure:** Quality of life Questionnaire

**Time Frame:** After 8 Weeks (end of intervention)

**Description:** 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).

**Measure:** Quality of life Questionnaire

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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).

**Measure:** International Physical Activity Questionnaire

**Time Frame:** After 8 Weeks (end of intervention)

**Description:** 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).

**Measure:** International Physical Activity Questionnaire

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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.

**Measure:** Mediterranean Diet Adhrence Screener

**Time Frame:** After 8 Weeks (end of intervention)

**Description:** 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.

**Measure:** Mediterranean Diet Adhrence Screener

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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.

**Measure:** Mindful Attention and Awareness Scale

**Time Frame:** After 8 Weeks (end of intervention)

**Description:** 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.

**Measure:** Mindful Attention and Awareness Scale

**Time Frame:** Follow-up 3 Moths after the intervention

**Description:** 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.

**Measure:** Safety evaluation

**Time Frame:** After 8 Weeks (end of intervention)

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marcela.winkler@rbk.de

**Name:** Marcela Winkler, Dr

**Phone:** +49711 8181

**Phone Ext:** 2073

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stuttgart

**Country:** Germany

**Facility:** Robert-Bosch-Krankenhaus

**State:** Baden Würtenberg

**Zip:** 70341

#### Overall Officials

**Official 1:**

**Affiliation:** Robert Bosch Gesellschaft für Medizinische Forschung mbH

**Name:** Marcela Winkler, Dr

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
