Stress, JobMindYouNCT06227130
Meditation, Mindfulness, and Yoga to Reduce Perceived Stress in Resident Doctors - A Randomized Controlled Trial With Crossover Design
A study testing MindYou in people with Stress, Job, run by Region Skane at 2 sites in Sweden.
Trial summary
General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Job
- What is being tested?
- MindYou
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Jun 2024to 1 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident doctor in primary care having felt work related stress at any time
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Educational Meeting for Resident Physicians in Lund
Lund
Educational Meeting for Resident Physicians in Malmö
Malmö
About this study
Official title: Does a 6-week Specially Designed Meditation, Mindfulness, and Yoga Program Reduce Perceived Stress in Resident General Practitioners? - A Randomized Controlled Trial With Crossover Design.
General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. The aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.
Read the detailed description
The study is designed as a randomized controlled trial with a crossover design. The outcome measure is the level of stress assessed using the Perceived Stress Scale (PPS), Swedish version (PSS 14). Inclusion criteria are resident general practitioners in Skåne, within the preliminary catchment area of Malmö Trelleborg, who have experienced any form of stress symptoms they believe are related to their work. Participants will be recruited through an oral presentation during an educational seminar in spring 2024. Those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. Participants will be randomised to intervention (I) or waiting list (C). The interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). The sessions will be sent to the participant on USB-stick or via webb-link. Each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. The preliminary themes that will be addressed are 'Handling Mistakes,' 'Letting Go of Work,' 'Setting Boundaries,' 'Taking Breaks,' 'Being Good Enough,' and 'Managing Work Stress. The participants are encouraged to perform the program at least 3 times/week. Both groups will fill in the PSS-questionnaire at study start and after 6 weeks.
The control group will start the intervention after the second questionnaire (week 7-12) and will fill out the PSS-questionnaire a third time after intervention completion. The results will be analysed according to intention to treat. The Mann-Whitney U-test will be used to compare whether there is a significant difference in the change of median values on PSS 14 between the intervention and control groups.
- Conditions
- Stress, Job
- Being tested
- MindYou
- Keywords
- yoga, mindfulness, meditation
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindYouBehavioural
A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Experimental: Intervention A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work. Each session lasts for about 20 minutes and the participant is encouraged to perform the session at least 3 times/week. Receives: Behavioral: MindYou |
| Waiting list | Active comparator | The first 6 weeks of the study, the participants will be controls. During week 6-12 they will then perform the intervention according to the description above. Receives: Behavioral: MindYou |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSS14
Self perceived stress According till PSS 14
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start4 Jun 2024
- Primary completion14 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, JobStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention group (IG) and waiting group (WG). IG will start with intervention program. After 6 weeks WG does the intervention program. PSS-questionnaire will be performed at baseline and after 6 weeks for both groups, and after 12 weeks for WG.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moa Wolff, Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227130
- Sponsor's protocol ID
- Dnr 2023-05678-01
- Acronym
- MindYou
- Status last verified
- Apr 2025
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a 6-week Specially Designed Meditation, Mindfulness, and Yoga Program Reduce Perceived Stress in Resident General Practitioners? - A Randomized Controlled Trial With Crossover Design.
- ClinicalTrials.gov ID
- NCT06227130
- Acronym / sponsor ID
- MindYou / Dnr 2023-05678-01
- Conditions
- Stress, Job
- Keywords
- yoga, mindfulness, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- 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.
General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. The aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.
Detailed description
The study is designed as a randomized controlled trial with a crossover design. The outcome measure is the level of stress assessed using the Perceived Stress Scale (PPS), Swedish version (PSS 14). Inclusion criteria are resident general practitioners in Skåne, within the preliminary catchment area of Malmö Trelleborg, who have experienced any form of stress symptoms they believe are related to their work. Participants will be recruited through an oral presentation during an educational seminar in spring 2024. Those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. Participants will be randomised to intervention (I) or waiting list (C). The interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). The sessions will be sent to the participant on USB-stick or via webb-link. Each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. The preliminary themes that will be addressed are 'Handling Mistakes,' 'Letting Go of Work,' 'Setting Boundaries,' 'Taking Breaks,' 'Being Good Enough,' and 'Managing Work Stress. The participants are encouraged to perform the program at least 3 times/week. Both groups will fill in the PSS-questionnaire at study start and after 6 weeks.
The control group will start the intervention after the second questionnaire (week 7-12) and will fill out the PSS-questionnaire a third time after intervention completion. The results will be analysed according to intention to treat. The Mann-Whitney U-test will be used to compare whether there is a significant difference in the change of median values on PSS 14 between the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group (IG) and waiting group (WG). IG will start with intervention program. After 6 weeks WG does the intervention program. PSS-questionnaire will be performed at baseline and after 6 weeks for both groups, and after 12 weeks for WG.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MindYouExperimental: Intervention A specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work. Each session lasts for about 20 minutes and the participant is encouraged to perform the session at least 3 times/week. |
| Waiting list | Active comparator | Behavioral: MindYouThe first 6 weeks of the study, the participants will be controls. During week 6-12 they will then perform the intervention according to the description above. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident doctor in primary care having felt work related stress at any time
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| MindYouA specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work. | Behavioural | Intervention, Waiting list |
Primary outcome
PSS14
Time frame: 12 weeks
Self perceived stress According till PSS 14
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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Moa Wolff study director
Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindYou in people with Stress, Job, run by Region Skane at 2 sites 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 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PSS14 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.