Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Qualitative interviews in focus groups interviews |
Qualitative assessment will be carried out in 45-minute focus group interviews in 12 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis. |
12 weeks after inclusion |
|
| Primary |
Stress questionnaire (Cohen Perceived Stress Scale, CPSS) |
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress. |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Medical Outcomes Study Short Form Quality of Life (MOS SF-36) |
Assessing full scale, range 0-100, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) |
Assessing full scale, range 0-42, lower score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Zerssen symptom list (B-LR and B-LR') |
Assessing full scale, range 20-80, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
International Physical Activity Questionnaire (IPAQ) |
MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Maslach Burnout Inventory (MBI) |
Assessing full scale, range 0-96, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) |
Assessing full scale, range 0-56, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Aspects of Spirituality (ASP) |
Assessing full scale, range 0-112, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Self-Regulation |
Assessing full scale, range 16-96, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Multidimensional Assessment of Interoceptive Awareness (MAIA) |
Assessing full scale, range 0-160, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Trauma symptoms (Posttraumatic Checklist, PCL-5) |
Assessing full scale, range 0-80, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Mysticism Scale Short Form |
Assessing full scale, range 0-32, higher score meaning a better outcome |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Numerical Analog Scales |
Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each. |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Expectation questions |
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) |
Date of inclusion (baseline) |
|
| Secondary |
Evaluation questions |
For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) |
After 12 weeks, after 24 weeks |
|
| Secondary |
Bio-electrical Impedance Analysis (BIA) |
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg) |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS) |
Quantitative description of nutritional habits |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Medication intake |
Name of medication and dosage |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Heart Rate Variability (HRV) |
24h measuring by Faros 180 (chest) |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Sociodemographic Measurements |
Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications |
Date of inclusion (baseline) |
|
| Secondary |
Behavioral questions: alcohol consumption |
Number of alcoholic beverages on average per week in the last month |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Behavioral questions: relaxation |
Relaxation behavior on average per week in the last month in minutes |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Behavioral questions: cigarettes |
Number of cigarettes on average per week in the last month in minutes |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Electrodermal Activity (Galvanic Skin Response) |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Blood Volume Pulse |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Respiration Rate |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Interbeat Interval (IBI) |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Heart Rate (HR) |
24h measuring by Faros 180 (chest), Biovotion Everion |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Skin Temperature |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Blood Oxygenization |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Body weight (kg) |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Body Mass Index (kg/m2) |
|
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
| Secondary |
Waist circumference (cm) |
|
Date of inclusion (baseline), after 12 weeks, after 24 weeks |
|
