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Yoga and Psychological and Physiological Health

Primary Purpose

Stress, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Yin yoga
YOMI
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring yoga, stress, anxiety, depression, sleep quality, physiological stress, biomarkers

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • KFE, Skåne University Hospital in Malmö

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control arm

Yin yoga intervention arm

YOMI program intervention arm

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
Office and 24-hour blood pressure measurement (mmHg)
Blood pressure measurements will be taken periodically by the device for a period of 24-hours.
Pulse-wave velocity
Measured using a sphygmocor device.
Heart rate variability
Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.
Gut microbiota
Fecal samples.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2018
Last Updated
February 13, 2018
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03428542
Brief Title
Yoga and Psychological and Physiological Health
Official Title
The Effects of Yoga on Psychological and Physiological Health in a Population Based Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 11, 2016 (Actual)
Primary Completion Date
April 23, 2016 (Actual)
Study Completion Date
April 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression, Sleep, Physiological Stress
Keywords
yoga, stress, anxiety, depression, sleep quality, physiological stress, biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Instructed not to practice any yoga or mindfulness during the five-week study period.
Arm Title
Yin yoga intervention arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
YOMI program intervention arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yin yoga
Intervention Description
Yin yoga 2 times per week for 5 weeks. Daily breathing assignments.
Intervention Type
Behavioral
Intervention Name(s)
YOMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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
Title
The Hospital Anxiety and Depression Scale
Description
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
Title
The COPE Inventory
Description
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
Title
The Insomnia Severity Index
Description
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
Title
Diet
Description
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
Title
General Health Questionnaire
Description
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
Title
The Harmony in Life Scale
Description
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
Title
The Kentucky Inventory of Mindfulness Skills -Short Version
Description
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
Title
The Brief Experiential Avoidance Questionnaire
Description
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
Title
The Self-Compassion Scale
Description
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
Title
Fasting blood sampling
Description
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
Title
Fasting and 120-minute glucose tolerance test (mmol/L)
Description
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
Title
Office and 24-hour blood pressure measurement (mmHg)
Description
Blood pressure measurements will be taken periodically by the device for a period of 24-hours.
Time Frame
5 weeks
Title
Pulse-wave velocity
Description
Measured using a sphygmocor device.
Time Frame
5 weeks
Title
Heart rate variability
Description
Measured with electrocardiogram during deep breathing. Heart rate variability is is the variation in the time interval between heartbeats.
Time Frame
5 weeks
Title
Gut microbiota
Description
Fecal samples.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olle Melander, MD, Prof.
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KFE, Skåne University Hospital in Malmö
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30020987
Citation
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.
Results Reference
derived

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Yoga and Psychological and Physiological Health

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