Stress, Psychological
Conditions
Keywords
Yoga, Meditation, Progressive muscle relaxation, Stress, Education
Brief summary
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
Interventions
BEHAVIORALIntegrative Yoga
A 12-week Integrative Yoga intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
BEHAVIORALIyengar Yoga
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
BEHAVIORALMindfulness
A 12-week mindfulness intervention designed for the healthy handling of stress.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* serious acute or chronic diseases * pregnancy or lactation * known serious mental illness * immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause * participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress questionnaire (Cohen Perceived Stress Scale, CPSS) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Faros 180 (chest) |
| Medical Outcomes Study Short Form Quality of Life (MOS SF-36) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-100, higher score meaning a better outcome |
| Hospital Anxiety and Depression Scale (HADS) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-42, lower score meaning a better outcome |
| Zerssen symptom list (B-LR and B-LR') | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 20-80, higher score meaning a better outcome |
| International Physical Activity Questionnaire (IPAQ) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 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. |
| Maslach Burnout Inventory (MBI) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-96, higher score meaning a better outcome |
| Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-56, higher score meaning a better outcome |
| Aspects of Spirituality (ASP) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-112, higher score meaning a better outcome |
| Self-Regulation | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 16-96, higher score meaning a better outcome |
| Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Quantitative description of nutritional habits |
| Medication intake | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Name of medication and dosage |
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-160, higher score meaning a better outcome |
| Trauma symptoms (Posttraumatic Checklist, PCL-5) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-80, higher score meaning a better outcome |
| Mysticism Scale Short Form | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-32, higher score meaning a better outcome |
| Numerical Analog Scales | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each. |
| Expectation questions | Date of inclusion (baseline) | For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) |
| Bio-electrical Impedance Analysis (BIA) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg) |
| Sociodemographic Measurements | Date of inclusion (baseline) | 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 |
| Behavioral questions: alcohol consumption | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Number of alcoholic beverages on average per week in the last month |
| Behavioral questions: relaxation | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Relaxation behavior on average per week in the last month in minutes |
| Behavioral questions: cigarettes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Number of cigarettes on average per week in the last month in minutes |
| Electrodermal Activity (Galvanic Skin Response) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Blood Volume Pulse | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Respiration Rate | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Interbeat Interval (IBI) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Heart Rate (HR) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Faros 180 (chest), Biovotion Everion |
| Skin Temperature | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Blood Oxygenization | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| Body weight (kg) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 24h measuring by Biovotion Everion device |
| 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 | — |
| Evaluation questions | After 12 weeks, after 24 weeks | For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews in focus groups interviews | 12 weeks after inclusion | 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. |
Countries
Germany
Outcome results
None listed