ClinicalTrials.gg
CompletedNCT03428542Updated Feb 14, 2018

Yoga and Psychological and Physiological Health

An interventional study of Yin yoga and YOMI in Stress, Anxiety and Depression, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Region Skane · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2016, registered Jan 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Depression by Region Skane — 2 open to participants now, 2 under way, none of them phase 3. Depression · Region Skane.

Started
2016
the only one that year
No phase
5 of 10
none open now
Registered
3rd of 10
by date

Among the 10 studies in Depression by Region Skane, this one is the only one that started in 2016, is one of 5 with no phase, and was the 3rd registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

2 of the 10 studies in Depression by Region Skane are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 40 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Depression by Region Skane, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Stress
  • Anxiety
  • Depression
  • Sleep
  • Physiological Stress

Browse trials for

Keywords

  • yoga
  • stress
  • anxiety
  • depression
  • sleep quality
  • physiological stress
  • biomarkers
04

In context

Depression Reclassified

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

This study's enrollment of 105 is above the median of 81 across 7,066 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • No intervention
    Control arm

    Instructed not to practice any yoga or mindfulness during the five-week study period.

  • Active comparator
    Yin yoga intervention arm

    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.

    Behavioral: Yin yoga

  • Active comparator
    YOMI program intervention arm

    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.

    Behavioral: YOMI

Interventions

  • BehavioralYin yoga

    Yin yoga 2 times per week for 5 weeks. Daily breathing assignments.

  • BehavioralYOMI

    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.

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 weeks

  2. 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).

    Time frame: 5 weeks

  3. 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.

    Time frame: 5 weeks

  4. 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.

    Time frame: 5 weeks

  5. 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.

    Time frame: 5 weeks

  6. 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.

    Time frame: 5 weeks

  7. 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.

    Time frame: 5 weeks

  8. 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.

    Time frame: 5 weeks

  9. 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).

    Time frame: 5 weeks

  10. 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.

    Time frame: 5 weeks

  11. 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.

    Time frame: 5 weeks

  12. 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.

    Time frame: 5 weeks

  13. Office and 24-hour blood pressure measurement (mmHg)

    Blood pressure measurements will be taken periodically by the device for a period of 24-hours.

    Time frame: 5 weeks

  14. Pulse-wave velocity

    Measured using a sphygmocor device.

    Time frame: 5 weeks

  15. Heart rate variability

    Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.

    Time frame: 5 weeks

  16. Gut microbiota

    Fecal samples.

    Time frame: 5 weeks

08

Study locations

1 site
  • KFE, Skåne University Hospital in Malmö
    Malmö, 20502, Sweden
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Apr 2016, 3 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 3 months is below that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2018
First posted
Feb 9, 2018
StartActual
Jan 11, 2016
Primary completionActual
Apr 23, 2016
CompletionActual
Apr 23, 2016
Last update
Feb 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03428542
Lead sponsor
Region Skane
Collaborators
Lund University
Responsible party
Olle Melander (Professor, Region Skane) — Principal investigator
First posted
Feb 9, 2018
Start date
Jan 11, 2016
Primary completion
Apr 23, 2016
Completion
Apr 23, 2016
Last update
Feb 14, 2018

Study contacts

Olle Melander, MD, Prof.
principal investigator · Lund University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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