StressNCT05699382
Improvement Mental Health Among Physicians by a Mindfulness-training Mobile Application
A study testing practiced mindfulness through the application for 6 weeks in people with Stress, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- practiced mindfulness through the application for 6 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 1 Dec 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physicians Working full-time at the Rambam Healthcare Campus.
Who cannot join
- Physicians that won't be able to participate in at least 50% of the practicing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement in Mental Health Markers Among Hospital Physicians Through a Mindfulness-training Mobile Application - Randomized Controlled Trial
The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians
Read the detailed description
Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks and a control group (CG). Main Measures: All participants filled-out questionnaires assessing stress (Perceived Stress Scale-PSS), mental health (Mental Health Inventory-MHI) and burnout (Maslach Burnout Inventory-MBI) at baseline and 7 weeks later
- Conditions
- Stress
- Being tested
- practiced mindfulness through the application for 6 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practiced mindfulness through the application for 6 weeksOther
Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| a study group (SG) in which participants practiced mindfulness through the application for 6 weeks | Active comparator | a study group (SG) in which participants practiced mindfulness through the application for 6 weeks Receives: Other: practiced mindfulness through the application for 6 weeks |
| control group | No intervention | Waiting for the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale-PSS
Differences in stress between baseline and 7 weeks later - will be assessed by Perceived Stress Scale-PSS
Measured: 7 weeks
Secondary outcomes (2)
Mental Health Inventory-MHI
Differences in Mental health between baseline and 7 weeks later will be assessed by Mental Health Inventory-MHI
Measured: 7 weeks
Maslach Burnout Inventory - MBI
Differences in Burn out between baseline and 7 weeks later will be assessed by Maslach Burnout Inventory - MBI
Measured: 7 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 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yonatan butbul MD, Rambam Health Care Campus
- Investigators
- Yonatan Butbul, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699382
- Sponsor's protocol ID
- 0150-20-RMB
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Mental Health Markers Among Hospital Physicians Through a Mindfulness-training Mobile Application - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05699382
- Acronym / sponsor ID
- 0150-20-RMB
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 26 Jan 2023 (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.
The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians
Detailed description
Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks and a control group (CG). Main Measures: All participants filled-out questionnaires assessing stress (Perceived Stress Scale-PSS), mental health (Mental Health Inventory-MHI) and burnout (Maslach Burnout Inventory-MBI) at baseline and 7 weeks later
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a study group (SG) in which participants practiced mindfulness through the application for 6 weeks | Active comparator | Other: practiced mindfulness through the application for 6 weeksa study group (SG) in which participants practiced mindfulness through the application for 6 weeks |
| control group | No intervention | –Waiting for the intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians Working full-time at the Rambam Healthcare Campus.
Key exclusion criteria (1 listed)
- Physicians that won't be able to participate in at least 50% of the practicing.
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 |
|---|---|---|
| practiced mindfulness through the application for 6 weeksPhysicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks | Other | a study group (SG) in which participants practiced mindfulness through the application for 6 weeks |
Primary outcome
Perceived Stress Scale-PSS
Time frame: 7 weeks
Differences in stress between baseline and 7 weeks later - will be assessed by Perceived Stress Scale-PSS
2 secondary outcomes
Mental Health Inventory-MHI
Time frame: 7 weeks
Maslach Burnout Inventory - MBI
Time frame: 7 weeks
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 26 Jan 2023.
- Individual participant dataSharing planned: No. Will be available on request
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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.
Yonatan Butbul principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing practiced mindfulness through the application for 6 weeks in people with Stress, run by Rambam Health Care Campus at 1 site in Israel.
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 26 Jan 2023. 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 Israel. 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: 7 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 26 Jan 2023.