Stress (Psychology)Mindful-MedNCT07171697
Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns.
A study testing Mindfulness and psycho-education in people with Stress (Psychology) and Burnout, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
The aim of this study is to evaluate the feasibility and acceptability of a mindfulness-based healthcare education (MBHC) programme with medical interns. Specific objectives are to: Recruit at least 24 participants to the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress (Psychology), Burnout, Mindfulness
- What is being tested?
- Mindfulness and psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working as a medical intern within RCSI hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the feasibility and acceptability of a mindfulness-based healthcare education (MBHC) programme with medical interns. Specific objectives are to:
- Recruit at least 24 participants to the study.
- Examine the feasibility (recruitment and retention rates) and acceptability of the MBHC programme.
- Conduct a focus group process evaluation, exploring the interns' perceptions of the MBHC programme, including their adherence to and views on the acceptability of the MBHC programme for medical interns.
- Conditions
- Stress (Psychology), Burnout, Mindfulness
- Being tested
- Mindfulness and psycho-education
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and psycho-educationBehavioural
4 week tailored mindfulness and psychoeducation programme for medical interns
| Study group | Role | What they receive |
|---|---|---|
| Receipt of mindfulness programme | Other | Not described Receives: Behavioral: Mindfulness and psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Maslach Burnout Inventory - The Maslach Burnout Inventory (MBI) (Maslach et al., 1996) is a measure of work-related burnout (Crowder and Sears, 2017). It comprises twenty-two items, with three subscales which assess: (1) Emotional exhaustion, (2) Depersonalisation of service users, (3) Personal achievement. The scale is scored on a seven-point Likert scale (0 = never; 6 = everyday). The subscales highlight levels of burnout, with differing cut-off points specified for each subscale. The emotional exhaustion subscale ranges from low levels of burnout (seventeen or less), through moderate levels of burnout (eighteen to twenty-nine), to high levels of burnout (thirty or more). The depersonalisation of service users subscale ranges from low-level burnout (five or less), through moderate burnout (six to eleven), to high-level burnout (twelve or more).
Measured: Up to 4 weeks
Stress
Perceived Stress Scale - The Perceived Stress Scale (PSS) (Cohen et al., 1983) is widely used to assess an individual's perception of stress. It comprised ten items developed to assess how unpredictable or uncontrollable participants feel their lives are (Cohen, 1994). The scale is scored on a five-point Likert scale (0 = never; 4 = very often), with higher scores indicative of greater levels of stress.
Measured: Up to 4 weeks
Secondary outcomes (1)
Mindfulness
Southampton Mindfulness Questionnaire - The Southampton Mindfulness Questionnaire (SMQ) (Chadwick et al., 2008) is a measure which assesses aspects of individual mindfulness resulting from unpleasant thoughts and images comprising of sixteen items. It is scored on a seven-point Likert scale (0 = Disagree totally; 6 = Agree totally), with higher scores indicative of greater mindfulness. The scale comprises four, four-item, subscales assessing (i) Mindful observation (SMQ-MO); (ii) Non-attachment (SMQ-NA); (iii) Aversion (SMQ-Av); (iv) Non-judgement (SMQ-NJ).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress (Psychology)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 4 week tailored mindfulness and psychoeducation programme
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171697
- Sponsor's protocol ID
- Mindful-Med 2025
- Other IDs
- Mindful-Med
- Acronym
- Mindful-Med
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns.
- ClinicalTrials.gov ID
- NCT07171697
- Acronym / sponsor ID
- Mindful-Med / Mindful-Med 2025
- Conditions
- Stress (Psychology), Burnout, Mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Sep 2025 (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 this study is to evaluate the feasibility and acceptability of a mindfulness-based healthcare education (MBHC) programme with medical interns. Specific objectives are to:
- Recruit at least 24 participants to the study.
- Examine the feasibility (recruitment and retention rates) and acceptability of the MBHC programme.
- Conduct a focus group process evaluation, exploring the interns' perceptions of the MBHC programme, including their adherence to and views on the acceptability of the MBHC programme for medical interns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 4 week tailored mindfulness and psychoeducation programme
| Arm | Type | Receives |
|---|---|---|
| Receipt of mindfulness programme | Other | Behavioral: Mindfulness and psycho-education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Working as a medical intern within RCSI hospital
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 |
|---|---|---|
| Mindfulness and psycho-education4 week tailored mindfulness and psychoeducation programme for medical interns | Behavioural | Receipt of mindfulness programme |
Primary outcome
Burnout
Time frame: Up to 4 weeks
Maslach Burnout Inventory - The Maslach Burnout Inventory (MBI) (Maslach et al., 1996) is a measure of work-related burnout (Crowder and Sears, 2017). It comprises twenty-two items, with three subscales which assess: (1) Emotional exhaustion, (2) Depersonalisation of service users, (3) Personal achievement. The scale is scored on a seven-point Likert scale (0 = never; 6 = everyday). The subscales highlight levels of burnout, with differing cut-off points specified for each subscale. The emotional exhaustion subscale ranges from low levels of burnout (seventeen or less), through moderate levels of burnout (eighteen to twenty-nine), to high levels of burnout (thirty or more). The depersonalisation of service users subscale ranges from low-level burnout (five or less), through moderate burnout (six to eleven), to high-level burnout (twelve or more).
Stress
Time frame: Up to 4 weeks
Perceived Stress Scale - The Perceived Stress Scale (PSS) (Cohen et al., 1983) is widely used to assess an individual's perception of stress. It comprised ten items developed to assess how unpredictable or uncontrollable participants feel their lives are (Cohen, 1994). The scale is scored on a five-point Likert scale (0 = never; 4 = very often), with higher scores indicative of greater levels of stress.
1 secondary outcome
Mindfulness
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
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 Mindfulness and psycho-education in people with Stress (Psychology) and Burnout, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Burnout (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. 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 12 Sep 2025.