Yoga and Psychological and Physiological Health

NCT03428542 | Completed DMC

• 1 other identifier: 2015610
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Anxiety; Depression; Sleep; Physiological Stress

Keywords

yoga; stress; anxiety; depression; sleep quality; physiological stress; biomarkers

Outcome Measures

Primary Outcomes (16)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  5 weeks

• Pulse-wave velocity

  Measured using a sphygmocor device.

  5 weeks

• Heart rate variability

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

  5 weeks

• Gut microbiota

  Fecal samples.

  5 weeks

Study Arms (3)

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.

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.

Behavioral: YOMI

Interventions

Yin yoga BEHAVIORAL

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

Yin yoga intervention arm

YOMI BEHAVIORAL

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.

YOMI program intervention arm

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

KFE, Skåne University Hospital in Malmö

Malmo, 20502, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30020987 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olle Melander, MD, Prof.

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 9, 2018
• Study Start: January 11, 2016
• Primary Completion: April 23, 2016
• Study Completion: April 23, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)