Yoga and Psychological and Physiological Health

NCT ID: NCT03428542

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-11
• Study Completion Date: 2016-04-23

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.

Conditions

Stress; Anxiety; Depression; Sleep; Physiological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Yin yoga

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

YOMI

Intervention Type: 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.

Interventions

Yin yoga

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

Intervention Type: BEHAVIORAL

YOMI

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Olle Melander

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olle Melander, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

KFE, Skåne University Hospital in Malmö

Malmo, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 30020987 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015610

Identifier Type: -

Identifier Source: org_study_id