Medical Yoga for Patients With Stress-related Symptoms and Diagnoses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elisabeth Westerdahl, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01604707
First received: May 15, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Stress
Anxiety
Depression
Other: Medical Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Medical Yoga for Patients With Stress-related Symptoms and Diagnoses in Primary Health Care - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • Perceived stress scale [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Shirom-Melamed Burnout Questionnaire [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Standard care
Experimental: Medical Yoga
Group training with medical yoga in primary health care.
Other: Medical Yoga
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.
Other Name: Medical Yoga group

Detailed Description:

Main outcome:

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. The citation for the 10-item scale is Cohen, S., & Williamson, G. (1988). Perceived stress in a probability sample of the United States. In S. Spacapan & S. Oskamp (Eds.). The Perceived Stress Scale is the only empirically established index of general stress appraisal. "The PSS measures the degree to which situations in one's life are appraised as stressful" (Cohen, et al., 1983; p. 385).

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.

The PSS is not a diagnostic instrument, so there are no cut-offs. There are only comparisons between people in a given sample. There are some normative data on the PSS based on a 1983 Harris Poll of a representative U.S. sample. These data may be helpful in providing comparisons, but they are over 20 years old. See: Cohen, S., & Williamson, G. (1988).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604707

Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Elisabeth Westerdahl, PhD University Hospital Orebro
  More Information

Publications:
Responsible Party: Elisabeth Westerdahl, PhD, Registered Physiotherapist, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01604707     History of Changes
Other Study ID Numbers: MEDYOG 1
Study First Received: May 15, 2012
Last Updated: June 4, 2014
Health Authority: Sweden: Swedish Research Council

Keywords provided by University Hospital Orebro:
stress
anxiety
depression
quality of life

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 19, 2014