Stress-related Illness/AnxietyNCT02907138
Medical Yoga for Patients With Stress-related Symptoms
A study testing Medical Yoga and Treatment as Usual (physical therapy) in people with Stress-related Illness/Anxiety, run by Maria Larsson at 1 site in Sweden.
Trial summary
The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms. Forty people are to be randomized to either: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stress-related Illness/Anxiety
- What is being tested?
- Medical Yoga and Treatment as Usual (physical therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to 4 Mar 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.
Who cannot join
- Do not understand Swedish (as group instructions need to be understood),
- Pregnancy,
- Psychotic symptoms,
- Ongoing or physical therapy treatment the last three months,
- Previously participated in Medical Yoga group.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms.
Forty people are to be randomized to either:
- Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist. or
- Control - treatment as usual (TAU) in physical therapy.
- Conditions
- Stress-related Illness/Anxiety
- Being tested
- Medical Yoga, Treatment as Usual (physical therapy)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical YogaOther
Treatment as Usual (physical therapy)Other
| Study group | Role | What they receive |
|---|---|---|
| Medical Yoga | Experimental | Medical Yoga Group therapy for eight weeks, 60 minutes per week, with the guidance of a physical therapist. Receives: Other: Medical Yoga |
| Treatment as Usual (physical therapy) | Active comparator | Treatment as Usual provided by physical therapist Receives: Other: Treatment as Usual (physical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Outcome will be measured as change between baseline and follow-ups and between follow-ups. Total score will also be analysed between groups at follow-up(s).
Measured: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Secondary outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
Measured: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Health-related quality of Life; EQ5D
Measured: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Thorax excursion: Measured in centimeters with tape measure, chest size at the level of processus xiphoideus, the difference between the maximum inhalation and exhalation is registered
Measured: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Health-related quality of Life; EQ-VAS
Measured: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion15 Feb 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-related Illness/AnxietyStudies 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
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Larsson
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Maria Larsson, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907138
- Sponsor's protocol ID
- VGFOUGSB-602221
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
Publications
Bellfjord M, Grimby-Ekman A, Larsson MEH. MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: A randomized controlled trial. PLoS One. 2024 Jun 13;19(6):e0300756. doi: 10.1371/journal.pone.0300756. eCollection 2024.
PubMed 38870156
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Yoga for Patients With Stress-related Symptoms
- ClinicalTrials.gov ID
- NCT02907138
- Acronym / sponsor ID
- VGFOUGSB-602221
- Conditions
- Stress-related Illness/Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maria LarssonOther government
- Study start
- Sep 2016
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 20 Sep 2016 (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.
The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms.
Forty people are to be randomized to either:
- Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist. or
- Control - treatment as usual (TAU) in physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Yoga | Experimental | Other: Medical YogaMedical Yoga Group therapy for eight weeks, 60 minutes per week, with the guidance of a physical therapist. |
| Treatment as Usual (physical therapy) | Active comparator | Other: Treatment as Usual (physical therapy)Treatment as Usual provided by physical therapist |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.
Key exclusion criteria (5 listed)
- Do not understand Swedish (as group instructions need to be understood),
- Pregnancy,
- Psychotic symptoms,
- Ongoing or physical therapy treatment the last three months,
- Previously participated in Medical Yoga group.
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 Yoga | Other | Medical Yoga |
| Treatment as Usual (physical therapy) | Other | Treatment as Usual (physical therapy) |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Outcome will be measured as change between baseline and follow-ups and between follow-ups. Total score will also be analysed between groups at follow-up(s).
4 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Health-related quality of Life; EQ5D
Time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Thorax excursion: Measured in centimeters with tape measure, chest size at the level of processus xiphoideus, the difference between the maximum inhalation and exhalation is registered
Time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Health-related quality of Life; EQ-VAS
Time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
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 16 Sep 2020.
- Derived from this study: PubMed 38870156Bellfjord M, Grimby-Ekman A, Larsson MEH. MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: A randomized controlled trial. PLoS One. 2024 Jun 13;19(6):e0300756. doi: 10.1371/journal.pone.0300756. eCollection 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Yoga and Treatment as Usual (physical therapy) in people with Stress-related Illness/Anxiety, run by Maria Larsson at 1 site in Sweden.
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 1 inclusion and 5 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (PSS) (time frame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session). 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 NCT02907138, which also lists 1 linked publication.
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 16 Sep 2020.