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The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Yoga | Experimental | A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. |
|
| Iyengar yoga | Active Comparator | A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). |
|
| Mindfulness | Active Comparator | A 12-week mindfulness intervention designed for the healthy handling of stress. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Yoga | Behavioral | A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hospital Anxiety and Depression Scale (HADS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
- stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charite - Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus | Berlin | 14109 | Germany |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Iyengar Yoga | Behavioral | A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). |
|
| Mindfulness | Behavioral | A 12-week mindfulness intervention designed for the healthy handling of stress. |
|
Assessing full scale, range 0-42, lower score meaning a better outcome
| Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Self-Regulation | Assessing full scale, range 16-96, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| Medication intake | Name of medication and dosage | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Heart Rate Variability (HRV) | 24h measuring by Faros 180 (chest) | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| 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) |
| 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 |
| 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 |
| 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 |
| Electrodermal Activity (Galvanic Skin Response) | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Blood Volume Pulse | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Respiration Rate | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Interbeat Interval (IBI) | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Heart Rate (HR) | 24h measuring by Faros 180 (chest), Biovotion Everion | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Skin Temperature | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Blood Oxygenization | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Body weight (kg) | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Body Mass Index (kg/m2) | Date of inclusion (baseline), after 12 weeks, after 24 weeks |
| Waist circumference (cm) | Date of inclusion (baseline), after 12 weeks, after 24 weeks |