StressNCT03428542
Yoga and Psychological and Physiological Health
A study testing Yin yoga and YOMI in people with Stress and Anxiety, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. The study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Yin yoga and YOMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2016to 23 Apr 2016
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A score on four items of the Perceived Stress Scale between 8-16, thereby indicating a current stress experience of at least moderate level.
- Ability to participate in the intervention during the time-period.
- Comprehensive in Swedish.
Who cannot join
- Ongoing yoga practice or any regular practice of yoga or meditation within the last 6 months.
- Any known physical limitations that may prevent light physical activity (yoga postures).
- Current psychological or psychopharmacological treatment.
- Inability to attend more than 5 of the scheduled 10 yoga sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Yoga on Psychological and Physiological Health in a Population Based Cohort
This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. The study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a particular focus on stress as the primary outcome.
Read the detailed description
Stress and worry in everyday life are common features of Western society. Stress is a biological mechanism tapping the fight-or-flight-response via activation of the sympathetic nervous system. When exposed to stress during prolonged periods of time, the immune system is affected, leading to physiological as well as psychosocial problems. The consequences of untreated high stress can not only turn into reduced job capacity, and work roles conflicts, but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and depression.
One common and recommended strategy to manage stress is to exercise regularly. Yoga is an umbrella term for a wide variety of physical, mental, and spiritual practices with its roots in ancient India. Most previous research on the health effects of yoga has demonstrated benefits on psychological health factors including mental stress, anxiety, depression and sleep problems.
The aim of the study is thus to investigate the effects of two types of yoga intervention on psychological and physiological health.
- Conditions
- Stress, Anxiety, Depression, Sleep, Physiological Stress
- Being tested
- Yin yoga, YOMI
- Keywords
- yoga, stress, anxiety, depression, sleep quality, physiological stress, biomarkers
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yin yogaBehavioural
Yin yoga 2 times per week for 5 weeks. Daily breathing assignments.
YOMIBehavioural
30 minutes of psychoeducation combined with mindfulness practice followed by 60 minutes of Yin yoga allowing the psychological theme to be further explored, aided by verbal instructions of the yoga teacher. 2 times per week for 5 weeks.
Daily breathing assignments.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Instructed not to practice any yoga or mindfulness during the five-week study period. |
| Yin yoga intervention arm | Active comparator | The Yin yoga intervention arm will receive Yin yoga, a calm-paced practice that uses seated and lying down positions.
Participants were also provided a CD which contained a 10-minute voice recording called conscious breathing. The guided instructions encouraged participants to keep awareness on their breath and to use calm, slow, nostril breathing. Receives: Behavioral: Yin yoga |
| YOMI program intervention arm | Active comparator | The YOMI intervention arm will receive stress education + yoga, and bring together education about stress, mindfulness and yoga practice. It will involve weekly group meetings, homework, and yoga postures. Stress education and mindfulness will make up one portion of the intervention. This will take place in a group lecture format and shall be conducted by a mental health professional(s). Yoga practice in a group format will make up the second portion of the intervention.
Participants were also provided a CD which contained a 10-minute voice recording called conscious breathing. The guided instructions encouraged participants to keep awareness on their breath and to use calm, slow, nostril breathing. Receives: Behavioral: YOMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
A 10-item scale measuring the degree to which situations in one's life are appraised as stressful.The items are rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating a higher stress level.
Measured: 5 weeks
The Hospital Anxiety and Depression Scale
A fourteen item scale which assesses levels of anxiety and depression. Seven of the 14 items relate to anxiety and seven relate to depression. Each item is scored from 0-3. Items can be scored together by subscale (score range: 0-21), or for total scale score (score range: 0-42).
Measured: 5 weeks
The COPE Inventory
Assesses 14 conceptually distinct coping strategies. It includes 13 scales with four items each and one single item question to assess different strategies for coping with stress. All items are reported on a 4-point scale.
Measured: 5 weeks
The Insomnia Severity Index
A brief screening measure of insomnia and an outcome measure for use in intervention research. The index contains seven items rated on a five-point Likert scale from 0 to 4. Higher scores indicate symptoms of insomnia.
Measured: 5 weeks
Diet
A 2-item measure that is used as an exploratory questionnaire. The questions are as follows: Have you changed your eating habits since you started your participation in the study? Categorical answer choices include 1) No, not at all, 2) Yes, to some extent, 3) Yes, to a great extent. A second question is open-ended: If you have changed your eating habits, please describe how. This very brief questionnaire will be given only once at the end of the study to explore whether dietary changes have occurred following the 5-week study period.
Measured: 5 weeks
General Health Questionnaire
Consists of 12 items, each one assessing the severity of a mental problem over the past few weeks using a 4-point Likert-type scale (from 0 to 3). These scores generate a total score ranging from 0 to 36 where higher scores indicate worse health.
Measured: 5 weeks
The Harmony in Life Scale
Assesses a global sense of harmony in one's life and consists of 5 statements for which participants are asked to indicate degree of agreement on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The harmony score is established by summarizing the 5 statements for each participant, allowing for a maximum score of 35 (range: 5 - 35). Higher scores represent greater harmony in life.
Measured: 5 weeks
The Kentucky Inventory of Mindfulness Skills -Short Version
A 20-item multi-dimensional scale of interrelated skills related to what one does while practicing mindfulness, and how one does it.
Measured: 5 weeks
The Brief Experiential Avoidance Questionnaire
A questionnaire which consists of 15 items used to assess behavioral avoidance , distress aversion, procrastination, distraction/suppression, repression/denial, and distress endurance. Participants are asked to indicate degree of agreement on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). The score is established by summing all items (score range: 15 - 90).
Measured: 5 weeks
The Self-Compassion Scale
A 26-item measure with six subscales, tapping the construct of self-compassion. The subscales are self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Scores of subscales are added together for a total score representative of the level of self-compassion.
Measured: 5 weeks
Fasting blood sampling
A total of 3 tubes will be collected for each participant, amounting to a total of 65ml of blood per person. Blood analysis will include stress hormones, inflammatory biomarkers, metabolic profiling, cardiometabolic biomarkers, cholesterol, triglycerides, creatinine, catecholamines (noradrenalin and adrenalin), renin, cortisol, and glucose concentration.
Measured: 5 weeks
Fasting and 120-minute glucose tolerance test (mmol/L)
The glucose tolerance test determines how the body responds to glucose (sugar). After a fasting blood sample is taken (see above procedure), participants will be asked to drink a liquid containing glucose. A second blood sample will be taken 120 minutes later.
Measured: 5 weeks
Office and 24-hour blood pressure measurement (mmHg)
Blood pressure measurements will be taken periodically by the device for a period of 24-hours.
Measured: 5 weeks
Pulse-wave velocity
Measured using a sphygmocor device.
Measured: 5 weeks
Heart rate variability
Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.
Measured: 5 weeks
Gut microbiota
Fecal samples.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start11 Jan 2016
- Primary completion23 Apr 2016
- Study completion23 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group RCT with three arms during 5 weeks. Subjects were randomized to a control group, the Yin Yoga intervention group or the YOMI intervention group. YOMI intervention combines Yin yoga with psychoeducation and mindfulness practice.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Olle Melander, Region Skane
- Investigators
- Olle Melander, MD, Prof., Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428542
- Sponsor's protocol ID
- 2015610
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daukantaite D, Tellhed U, Maddux RE, Svensson T, Melander O. Five-week yin yoga-based interventions decreased plasma adrenomedullin and increased psychological health in stressed adults: A randomized controlled trial. PLoS One. 2018 Jul 18;13(7):e0200518. doi: 10.1371/journal.pone.0200518. eCollection 2018.
PubMed 30020987
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga on Psychological and Physiological Health in a Population Based Cohort
- ClinicalTrials.gov ID
- NCT03428542
- Acronym / sponsor ID
- 2015610
- Conditions
- Stress, Anxiety, Depression, Sleep, Physiological Stress
- Keywords
- yoga, stress, anxiety, depression, sleep quality, physiological stress, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 23 Apr 2016 (actual)
- Study completion
- 23 Apr 2016 (actual)
- First posted
- 9 Feb 2018 (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.
This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. The study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a particular focus on stress as the primary outcome.
Detailed description
Stress and worry in everyday life are common features of Western society. Stress is a biological mechanism tapping the fight-or-flight-response via activation of the sympathetic nervous system. When exposed to stress during prolonged periods of time, the immune system is affected, leading to physiological as well as psychosocial problems. The consequences of untreated high stress can not only turn into reduced job capacity, and work roles conflicts, but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and depression.
One common and recommended strategy to manage stress is to exercise regularly. Yoga is an umbrella term for a wide variety of physical, mental, and spiritual practices with its roots in ancient India. Most previous research on the health effects of yoga has demonstrated benefits on psychological health factors including mental stress, anxiety, depression and sleep problems.
The aim of the study is thus to investigate the effects of two types of yoga intervention on psychological and physiological health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel-group RCT with three arms during 5 weeks. Subjects were randomized to a control group, the Yin Yoga intervention group or the YOMI intervention group. YOMI intervention combines Yin yoga with psychoeducation and mindfulness practice.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Instructed not to practice any yoga or mindfulness during the five-week study period. |
| Yin yoga intervention arm | Active comparator | Behavioral: Yin yogaThe Yin yoga intervention arm will receive Yin yoga, a calm-paced practice that uses seated and lying down positions. Participants were also provided a CD which contained a 10-minute voice recording called conscious breathing. The guided instructions encouraged participants to keep awareness on their breath and to use calm, slow, nostril breathing. |
| YOMI program intervention arm | Active comparator | Behavioral: YOMIThe YOMI intervention arm will receive stress education + yoga, and bring together education about stress, mindfulness and yoga practice. It will involve weekly group meetings, homework, and yoga postures. Stress education and mindfulness will make up one portion of the intervention. This will take place in a group lecture format and shall be conducted by a mental health professional(s). Yoga practice in a group format will make up the second portion of the intervention. Participants were also provided a CD which contained a 10-minute voice recording called conscious breathing. The guided instructions encouraged participants to keep awareness on their breath and to use calm, slow, nostril breathing. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A score on four items of the Perceived Stress Scale between 8-16, thereby indicating a current stress experience of at least moderate level.
- Ability to participate in the intervention during the time-period.
- Comprehensive in Swedish.
Key exclusion criteria (4 listed)
- Ongoing yoga practice or any regular practice of yoga or meditation within the last 6 months.
- Any known physical limitations that may prevent light physical activity (yoga postures).
- Current psychological or psychopharmacological treatment.
- Inability to attend more than 5 of the scheduled 10 yoga sessions.
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 |
|---|---|---|
| Yin yogaYin yoga 2 times per week for 5 weeks. Daily breathing assignments. | Behavioural | Yin yoga intervention arm |
| YOMI30 minutes of psychoeducation combined with mindfulness practice followed by 60 minutes of Yin yoga allowing the psychological theme to be further explored, aided by verbal instructions of the yoga teacher. 2 times per week for 5 weeks. Daily breathing assignments. | Behavioural | YOMI program intervention arm |
Primary outcome
Perceived Stress Scale
Time frame: 5 weeks
A 10-item scale measuring the degree to which situations in one's life are appraised as stressful.The items are rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating a higher stress level.
The Hospital Anxiety and Depression Scale
Time frame: 5 weeks
A fourteen item scale which assesses levels of anxiety and depression. Seven of the 14 items relate to anxiety and seven relate to depression. Each item is scored from 0-3. Items can be scored together by subscale (score range: 0-21), or for total scale score (score range: 0-42).
The COPE Inventory
Time frame: 5 weeks
Assesses 14 conceptually distinct coping strategies. It includes 13 scales with four items each and one single item question to assess different strategies for coping with stress. All items are reported on a 4-point scale.
The Insomnia Severity Index
Time frame: 5 weeks
A brief screening measure of insomnia and an outcome measure for use in intervention research. The index contains seven items rated on a five-point Likert scale from 0 to 4. Higher scores indicate symptoms of insomnia.
Diet
Time frame: 5 weeks
A 2-item measure that is used as an exploratory questionnaire. The questions are as follows: Have you changed your eating habits since you started your participation in the study? Categorical answer choices include 1) No, not at all, 2) Yes, to some extent, 3) Yes, to a great extent. A second question is open-ended: If you have changed your eating habits, please describe how. This very brief questionnaire will be given only once at the end of the study to explore whether dietary changes have occurred following the 5-week study period.
General Health Questionnaire
Time frame: 5 weeks
Consists of 12 items, each one assessing the severity of a mental problem over the past few weeks using a 4-point Likert-type scale (from 0 to 3). These scores generate a total score ranging from 0 to 36 where higher scores indicate worse health.
The Harmony in Life Scale
Time frame: 5 weeks
Assesses a global sense of harmony in one's life and consists of 5 statements for which participants are asked to indicate degree of agreement on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The harmony score is established by summarizing the 5 statements for each participant, allowing for a maximum score of 35 (range: 5 - 35). Higher scores represent greater harmony in life.
The Kentucky Inventory of Mindfulness Skills -Short Version
Time frame: 5 weeks
A 20-item multi-dimensional scale of interrelated skills related to what one does while practicing mindfulness, and how one does it.
The Brief Experiential Avoidance Questionnaire
Time frame: 5 weeks
A questionnaire which consists of 15 items used to assess behavioral avoidance , distress aversion, procrastination, distraction/suppression, repression/denial, and distress endurance. Participants are asked to indicate degree of agreement on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). The score is established by summing all items (score range: 15 - 90).
The Self-Compassion Scale
Time frame: 5 weeks
A 26-item measure with six subscales, tapping the construct of self-compassion. The subscales are self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Scores of subscales are added together for a total score representative of the level of self-compassion.
Fasting blood sampling
Time frame: 5 weeks
A total of 3 tubes will be collected for each participant, amounting to a total of 65ml of blood per person. Blood analysis will include stress hormones, inflammatory biomarkers, metabolic profiling, cardiometabolic biomarkers, cholesterol, triglycerides, creatinine, catecholamines (noradrenalin and adrenalin), renin, cortisol, and glucose concentration.
Fasting and 120-minute glucose tolerance test (mmol/L)
Time frame: 5 weeks
The glucose tolerance test determines how the body responds to glucose (sugar). After a fasting blood sample is taken (see above procedure), participants will be asked to drink a liquid containing glucose. A second blood sample will be taken 120 minutes later.
Office and 24-hour blood pressure measurement (mmHg)
Time frame: 5 weeks
Blood pressure measurements will be taken periodically by the device for a period of 24-hours.
Pulse-wave velocity
Time frame: 5 weeks
Measured using a sphygmocor device.
Heart rate variability
Time frame: 5 weeks
Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.
Gut microbiota
Time frame: 5 weeks
Fecal samples.
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 14 Feb 2018.
- Derived from this study: PubMed 30020987Daukantaite D, Tellhed U, Maddux RE, Svensson T, Melander O. Five-week yin yoga-based interventions decreased plasma adrenomedullin and increased psychological health in stressed adults: A randomized controlled trial. PLoS One. 2018 Jul 18;13(7):e0200518. doi: 10.1371/journal.pone.0200518. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Olle Melander, MD, Prof. principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yin yoga and YOMI in people with Stress and Anxiety, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 4 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 14 Feb 2018. 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 Sweden. 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?
Perceived Stress Scale (time frame: 5 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428542, which also lists 1 linked publication.
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 14 Feb 2018.