Stress, PsychologicalNCT04039074
Effects of Yoga and Relaxation on Stress and Quality of Life
A study testing Integrative Yoga, Iyengar Yoga and Mindfulness in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Integrative Yoga, Iyengar Yoga and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
About this study
Official title: Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
- Conditions
- Stress, Psychological
- Being tested
- Integrative Yoga, Iyengar Yoga, Mindfulness
- Keywords
- Yoga, Meditation, Progressive muscle relaxation, Stress, Education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative YogaBehavioural
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
Iyengar YogaBehavioural
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
MindfulnessBehavioural
A 12-week mindfulness intervention designed for the healthy handling of stress.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Yoga | Experimental | A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. Receives: Behavioral: Integrative Yoga |
| Iyengar yoga | Active comparator | A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). Receives: Behavioral: Iyengar Yoga |
| Mindfulness | Active comparator | A 12-week mindfulness intervention designed for the healthy handling of stress. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Secondary outcomes (32)
Medical Outcomes Study Short Form Quality of Life (MOS SF-36)
Assessing full scale, range 0-100, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Regulation
Assessing full scale, range 16-96, higher score meaning a better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Medication intake
Name of medication and dosage
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate Variability (HRV)
24h measuring by Faros 180 (chest)
Measured: 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
Measured: Date of inclusion (baseline)
Behavioral questions: alcohol consumption
Number of alcoholic beverages on average per week in the last month
Measured: 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
Measured: 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
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Electrodermal Activity (Galvanic Skin Response)
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Volume Pulse
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Respiration Rate
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Interbeat Interval (IBI)
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate (HR)
24h measuring by Faros 180 (chest), Biovotion Everion
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Skin Temperature
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Oxygenization
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body weight (kg)
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body Mass Index (kg/m2)
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Waist circumference (cm)
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start29 Jul 2019
- Primary completion21 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039074
- Sponsor's protocol ID
- Relax
- Status last verified
- Sep 2022
- First submitted
- 28 Jul 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04039074
- Acronym / sponsor ID
- Relax
- Conditions
- Stress, Psychological
- Keywords
- Yoga, Meditation, Progressive muscle relaxation, Stress, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrative Yoga | Experimental | Behavioral: Integrative YogaA 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. |
| Iyengar yoga | Active comparator | Behavioral: Iyengar YogaA 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). |
| Mindfulness | Active comparator | Behavioral: MindfulnessA 12-week mindfulness intervention designed for the healthy handling of stress. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative YogaA 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. | Behavioural | Integrative Yoga |
| Iyengar YogaA 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). | Behavioural | Iyengar yoga |
| MindfulnessA 12-week mindfulness intervention designed for the healthy handling of stress. | Behavioural | Mindfulness |
Primary outcome
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time frame: 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.
32 secondary outcomes
Medical Outcomes Study Short Form Quality of Life (MOS SF-36)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Zerssen symptom list (B-LR and B-LR')
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Maslach Burnout Inventory (MBI)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Aspects of Spirituality (ASP)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Regulation
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Trauma symptoms (Posttraumatic Checklist, PCL-5)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Mysticism Scale Short Form
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Numerical Analog Scales
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Expectation questions
Time frame: Date of inclusion (baseline)
Evaluation questions
Time frame: After 12 weeks, after 24 weeks
Bio-electrical Impedance Analysis (BIA)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Medication intake
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate Variability (HRV)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Sociodemographic Measurements
Time frame: Date of inclusion (baseline)
Behavioral questions: alcohol consumption
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: relaxation
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: cigarettes
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Electrodermal Activity (Galvanic Skin Response)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Volume Pulse
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Respiration Rate
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Interbeat Interval (IBI)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Heart Rate (HR)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Skin Temperature
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Blood Oxygenization
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body weight (kg)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Body Mass Index (kg/m2)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Waist circumference (cm)
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charite - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Yoga, Iyengar Yoga and Mindfulness in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress questionnaire (Cohen Perceived Stress Scale, CPSS) (time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.