MindfulnessNCT03614390
Mindfulness for Medical Students
A study testing mindfulness based cognitive therapy (MBCT) in people with Mindfulness and Burnout, Professional, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Burnout is common among medical students. Previous studies had shown that mindfulness based interventions may improve burnout and quality of life in medical students. Mindfulness-based cognitive therapy (MBCT) is one of the most often used mindfulness based interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Burnout, Professional
- What is being tested?
- mindfulness based cognitive therapy (MBCT)
- 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 siteHong Kong
- Study dates
- 7 Sep 2018to 28 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical students studying in Chinese University of Hong Kong
Who cannot join
- The investigators did not set any exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Burnout is common among medical students. Previous studies had shown that mindfulness based interventions may improve burnout and quality of life in medical students. Mindfulness-based cognitive therapy (MBCT) is one of the most often used mindfulness based interventions.
Medical students in the Chinese University of Hong Kong are invited to a MBCT on voluntary basis. They will be asked to fill in questionnaire that measures burnout, depression/anxiety, quality of life, and mindfulness at beginning and end of the MBCT. The pre-group and post-group data will be compared and analysed
- Conditions
- Mindfulness, Burnout, Professional
- Being tested
- mindfulness based cognitive therapy (MBCT)
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based cognitive therapy (MBCT)Behavioural
a well described and structured intervention, which is published previously. The psychoeducation materials in the MBCT will be titrated to discuss about low mood and burnout
| Study group | Role | What they receive |
|---|---|---|
| MBCT group | Other | There is only 1 arm in the study.
The MBCT will be conducted according to the treatment manual. The program consists of eight weekly sessions. In between sessions, participants are advised to practice mindfulness meditations for 40-50 minutes every day.
The teachers of the program will teach on voluntary basis. The teachers must have attended the 1-year foundation course to teach mindfulness (available in the United Kingdom and Hong Kong), regular mindfulness practice and must have at least yearly mindfulness retreat. This is in accordance to the good practice guidelines developed in the UK for mindfulness teachers Receives: Behavioral: mindfulness based cognitive therapy (MBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory (MBI)
The validated Maslach Burnout Inventory (MBI) is a 22-item questionnaire that assesses three aspects of professional burnout syndrome which includes emotional exhaustion, depersonalization and lack of personal accomplishment. It is widely used in research and has been widely used in studies about medical student well-being. In the scale, burnout is conceptualized as a continuous construct and participant is asked to rate their job related feelings using a 7-point Likert scale ranging from "never" to "everyday". A high degree of burnout is defined as a respondent who scores low on the Personal Accomplishment subscale but high in the Emotional Exhaustion and Depersonalization subscales of the instrument
Measured: 8 weeks (before and after MBCT; after 8 weekly sessions)
Secondary outcomes (3)
21-item Depression Anxiety Stress Scale (DASS-21)
The 21-item DASS-21 questionnaire will be used to assess the presence of depression, anxiety and tension/stress with 7 items per subscale. Each item is ranked from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The total score is computed by adding scores of each item and multiplying them by a factor of 2. Therefore, the total possible score ranges from 0 to 126. The questionnaire exhibits adequate validity and internal consistency among clinical and non-clinical samples
Measured: 8 weeks (before and after MBCT; after 8 weekly sessions)
the World Health Organization Quality of Life Assessment (WHOQOL-BREF)
The WHOQOL-BREF consisted of 26 items representing four underlying domains: environment, psychological, social relationship and physical health. Scores within each domain can be transformed to a scale of 0-100, with higher scores represent better quality of life. The scales was used in medical students' burnout research
Measured: 8 weeks (before and after MBCT; after 8 weekly sessions)
Five Facet Mindfulness Questionnaire (FFMQ)
The FFMQ consisted of 39 items representing five underlying constructs: observing, describing, acting with awareness, non-judging of inner experience and non-reactivity to inner experience. Each item is rated from 1 ("never or very rarely true) to 5 ("very often or always true"). Total Score can be obtained by summation of scores.The higher score represents a more mindful attitude in daily life.
Measured: 8 weeks (before and after MBCT; after 8 weekly sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start7 Sep 2018
- Primary completion26 Oct 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614390
- Sponsor's protocol ID
- CUHK-mind
- Status last verified
- Jan 2019
- First submitted
- 31 Jul 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available on request from other researchers
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Medical Students
- ClinicalTrials.gov ID
- NCT03614390
- Acronym / sponsor ID
- CUHK-mind
- Conditions
- Mindfulness, Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 3 Aug 2018 (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.
Burnout is common among medical students. Previous studies had shown that mindfulness based interventions may improve burnout and quality of life in medical students. Mindfulness-based cognitive therapy (MBCT) is one of the most often used mindfulness based interventions.
Medical students in the Chinese University of Hong Kong are invited to a MBCT on voluntary basis. They will be asked to fill in questionnaire that measures burnout, depression/anxiety, quality of life, and mindfulness at beginning and end of the MBCT. The pre-group and post-group data will be compared and analysed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT group | Other | Behavioral: mindfulness based cognitive therapy (MBCT)There is only 1 arm in the study. The MBCT will be conducted according to the treatment manual. The program consists of eight weekly sessions. In between sessions, participants are advised to practice mindfulness meditations for 40-50 minutes every day. The teachers of the program will teach on voluntary basis. The teachers must have attended the 1-year foundation course to teach mindfulness (available in the United Kingdom and Hong Kong), regular mindfulness practice and must have at least yearly mindfulness retreat. This is in accordance to the good practice guidelines developed in the UK for mindfulness teachers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students studying in Chinese University of Hong Kong
Key exclusion criteria (1 listed)
- The investigators did not set any exclusion criteria
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 based cognitive therapy (MBCT)a well described and structured intervention, which is published previously. The psychoeducation materials in the MBCT will be titrated to discuss about low mood and burnout | Behavioural | MBCT group |
Primary outcome
Maslach Burnout Inventory (MBI)
Time frame: 8 weeks (before and after MBCT; after 8 weekly sessions)
The validated Maslach Burnout Inventory (MBI) is a 22-item questionnaire that assesses three aspects of professional burnout syndrome which includes emotional exhaustion, depersonalization and lack of personal accomplishment. It is widely used in research and has been widely used in studies about medical student well-being. In the scale, burnout is conceptualized as a continuous construct and participant is asked to rate their job related feelings using a 7-point Likert scale ranging from "never" to "everyday". A high degree of burnout is defined as a respondent who scores low on the Personal Accomplishment subscale but high in the Emotional Exhaustion and Depersonalization subscales of the instrument
3 secondary outcomes
21-item Depression Anxiety Stress Scale (DASS-21)
Time frame: 8 weeks (before and after MBCT; after 8 weekly sessions)
the World Health Organization Quality of Life Assessment (WHOQOL-BREF)
Time frame: 8 weeks (before and after MBCT; after 8 weekly sessions)
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 8 weeks (before and after MBCT; after 8 weekly sessions)
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 Feb 2019.
- Individual participant dataSharing planned: Undecided. Data will be made available on request from other researchers
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Caregiver
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 based cognitive therapy (MBCT) in people with Mindfulness and Burnout, Professional, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 Feb 2019. 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 Hong Kong. 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?
Maslach Burnout Inventory (MBI) (time frame: 8 weeks (before and after MBCT; after 8 weekly sessions)). 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 4 Feb 2019.