NCT01604707

Brief Summary

Background An increasing number of patients are suffering from stress-related symptoms and diseases. No scientific studies have examined the effects of Medical yoga on stress-related symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga treatment in patients with stress-related symptoms and diagnosis in primary health care. Methods A randomized, controlled study was performed at a primary health care centre in Sweden from March to June 2011. Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age 53±12 years, seeking care for stress-related symptoms at the primary health care centre were included and followed up after the 12-week study period. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health status (Euro Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

May 15, 2012

Last Update Submit

October 3, 2016

Conditions

Keywords

stressanxietydepressionquality of life

Outcome Measures

Primary Outcomes (1)

  • Perceived stress scale

    The Perceived Stress Scale is a 10-item self report questionnaire that measures persons' evaluation of the stressfulness of the situations in the past month of their lives. Cohen, S., \& Williamson, G. (1988). PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. Scores can range from 0 to 40, with higher scores indicating greater stress.

    12 week

Secondary Outcomes (1)

  • Shirom-Melamed Burnout Questionnaire

    12 week

Study Arms (2)

Control group

NO INTERVENTION

Standard care

Medical Yoga

EXPERIMENTAL

Group training with medical yoga in primary health care.

Other: Medical Yoga

Interventions

Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care.

Also known as: Medical Yoga group
Medical Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients had sought treatment at the primary health centre during the previous 6 months.
  • The stress-related symptoms included fatigue, insomnia, anxiety, depression, hypertension, and musculoskeletal discomfort in the neck and shoulders.

You may not qualify if:

  • Inability to understand instructions, interpretation needs or physical or mental inability to carry out the Medical yoga exercises, such as mental retardation or dementia, and severe physical or mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kohn M, Persson Lundholm U, Bryngelsson IL, Anderzen-Carlsson A, Westerdahl E. Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:215348. doi: 10.1155/2013/215348. Epub 2013 Feb 26.

  • Anderzen-Carlsson A, Persson Lundholm U, Kohn M, Westerdahl E. Medical yoga: another way of being in the world-a phenomenological study from the perspective of persons suffering from stress-related symptoms. Int J Qual Stud Health Well-being. 2014 Jan 9;9:23033. doi: 10.3402/qhw.v9.23033. eCollection 2014.

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Elisabeth Westerdahl, PhD

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Registered Physiotherapist

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 24, 2012

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share