StressNCT01604707
Medical Yoga for Patients With Stress-related Symptoms and Diagnoses
A study testing Medical Yoga in people with Stress and Anxiety, run by Region Örebro County.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Medical Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Medical Yoga for Patients With Stress-related Symptoms and Diagnoses in Primary Health Care - a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Stress, Anxiety, Depression
- Being tested
- Medical Yoga
- Keywords
- stress, anxiety, depression, quality of life
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical YogaOther
Also called Medical Yoga group
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care |
| Medical Yoga | Experimental | Group training with medical yoga in primary health care. Receives: Other: Medical Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week
Secondary outcomes (1)
Shirom-Melamed Burnout Questionnaire
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Westerdahl, Region Örebro County
- Investigators
- Elisabeth Westerdahl, PhD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604707
- Sponsor's protocol ID
- MEDYOG 1
- Status last verified
- Oct 2016
- First submitted
- 15 May 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23533465Anderzen-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.
PubMed 24434055
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Yoga for Patients With Stress-related Symptoms and Diagnoses in Primary Health Care - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01604707
- Acronym / sponsor ID
- MEDYOG 1
- Conditions
- Stress, Anxiety, Depression
- Keywords
- stress, anxiety, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care |
| Medical Yoga | Experimental | Other: Medical YogaGroup training with medical yoga in primary health care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical YogaAlso: Medical Yoga groupPatients 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 | Medical Yoga |
Primary outcome
Perceived stress scale
Time frame: 12 week
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.
1 secondary outcome
Shirom-Melamed Burnout Questionnaire
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Results publication: PubMed 23533465Kohn 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.
- Results publication: PubMed 24434055Anderzen-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Westerdahl, PhD principal investigator
Region Örebro County
Questions about this trial
What is this clinical trial studying?
A study testing Medical Yoga in people with Stress and Anxiety, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress scale (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.