StressNCT04497909
Online Mindfulness for Medical Trainees
A study testing Mindfulness in people with Stress and Anxiety, run by University of Alberta at 1 site in Canada.
Trial summary
Medical students and medical residents are subject to increased stressors throughout their education. There is increased depression, anxiety, burnout, and distress in medical trainees compared to the general population. Globally, roughly 3 out of 10 medical students experience anxiety. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 22 Jun 2023
- 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
- A medical trainee who registered for the online mindfulness elective
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Online Mindfulness on Depression, Anxiety, Stress and Burnout in Medical Students and Residents
Medical students and medical residents are subject to increased stressors throughout their education. There is increased depression, anxiety, burnout, and distress in medical trainees compared to the general population. Globally, roughly 3 out of 10 medical students experience anxiety. A recent study also found that almost 3 out of 10 medical trainees experience depression or depressive symptoms and approximately 1 out of 10 have suicidal thoughts. All of this leads to poorer academics, increased dropout rates as well as reduced empathy and quality of care in affected trainees.
Mindfulness programs are increasingly being used in medical schools to help deal with increased levels of depression, anxiety, stress, and burnout. Several studies have looked at medical students, medical residents, and various other healthcare professionals. These programs have been found to reduce depression, anxiety and stress while significantly improving mood, well being and mindfulness.
Read more
Although in-person mindfulness programs have shown several benefits, there are limitations to its use in medical programs. A lack of time, flexibility, accessibility as well as the issue of cost, impact the uptake of in-person mindfulness programs. A potential alternative to this is online mindfulness programs. To date, there is limited research regarding medical students and online mindfulness programs. With that being said, studies focussed on other populations and online mindfulness have shown reductions in depression, anxiety and stress with improvements in mindfulness and mood.
The study being proposed involves providing online mindfulness to medical students and residents in an 8-week program that consists of 8, 1-hour sessions with a mindfulness coach. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of online mindfulness on anxiety, depression, stress and burnout. The results of this research may lead to future studies looking at the impact of online mindfulness practice for medical trainees and might also help open up the possibility of offering such programs in medical schools.
Read the detailed description
BACKGROUND
The transition to medical school and the subsequent years that follow are a period of increased stress on trainees. Research shows that there is a higher prevalence of depression, anxiety and burnout amongst U.S. and Canadian medical students compared to the general population. In addition, distress is consistently higher in medical trainees compared to the general population and in age matched non-medical students. A recent systematic review found the prevalence of depression or depressive symptoms in medical trainees to be 27.2% and suicidal ideation to be 11.1%. A separate systematic review found that the prevalence of anxiety in medical students was 33.8% globally. Increased levels of distress and anxiety lead to poorer academics and increased dropout rates, as well as a reduced empathy, enthusiasm, and quality of care.
An intervention that has been gaining traction in recent years to manage the psychological strain placed on medical trainees is mindfulness training. A study of 140 second year medical students participating in a 10-week mindfulness-based stress reduction program reported significant improvement in mood and reduced psychological distress. Similar results have been found in randomised controlled trials with health care professionals as well as surgical and psychiatric residents. Furthermore, a 2017 systematic review of 19 papers looking at the effectiveness of mindfulness interventions in healthcare professionals found them to decrease stress, anxiety and depression while improving mindfulness, empathy and mood. These benefits may potentially continue over the long term based on results from a 2018 longitudinal study of mindfulness training in medical and psychology students. At the six year follow up with the intervention group, they reported increased well being, mindfulness, and problem-focused coping.
Although in-person mindfulness training has shown several benefits, there are limitations to implementing these programs in the demanding schedules of medical trainees. In addition to a lack of time, flexibility, costs, anonymity, and accessibility may limit its effectiveness as well. A modality that may reduce these limitations is online mindfulness. This format allows flexibility with regards to when trainees would be able to access the material, it would be more cost effective and could be accessed from rural and remote areas as suggested in a 2020 pilot study completed with Australian rural medical students. Results indicated significant reduction in perceived stress and increases in self compassion 4 months after the 8-week online mindfulness program. Online mindfulness interventions have been studied in several other populations and a 2016 meta analysis of 15 randomised controlled trials, found online mindfulness interventions to reduce depression, anxiety, and stress with an associated increase in well being and mindfulness.
To date, there is limited research looking at online mindfulness as a tool for medical students and residents. The study being proposed here, would assess the impact of an online mindfulness intervention on medical trainees with regards to depression, anxiety, stress, burnout, and mindfulness.
OBJECTIVE
To explore the potential benefits of online mindfulness on depression, anxiety, stress, and burnout in medical trainees.
To explore the changes in mindfulness level over the course of an online mindfulness program offered to medical trainees.
HYPOTHESIS
The investigators hypothesize that medical students and residents that participate in the online mindfulness program will report reduced depression, stress, anxiety, and burnout as well as improved mindfulness.
MATERIALS AND METHODS
This study is a prospective observational study.
Procedure
Following recruitment, all participants will complete a general demographic form as well as four scales that measure depression, anxiety, stress, burnout, and mindfulness. The same four scales will be completed by all participants at the end of the mindfulness training and 3 months after the training.
Online Mindfulness Intervention (OMI)
All participants will be instructed by a mindfulness practitioner/coach online through 8, 1-hour sessions over the course of eight weeks. Trainees will have the ability to retrieve the online sessions at their convenience. Weekly journals will be provided to measure attendance and frequency and duration of mindfulness practice.
Instruments
General Demographic Form: A researcher created demographic data form (age, educational level, prior experience with mindfulness, history of depression and anxiety) to be completed by the medical trainees at enrolment.
Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be completed by the medical trainees at three time points.
Oldenburg Burnout Inventory for Students: 16 item scale to measure burnout in students completed at three time points.
Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto Mindfulness Scale will be completed by the medical trainees at three time points.
Mindfulness Weekly Journal: Document recording the duration and frequency of mindfulness practice during the study to assess attendance to the online class.
DATA ANALYSIS
Study data will be managed using Research Electronic Data Capture, a secure, web-based software platform, hosted at the University of Alberta. Group demographics will be compared with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group comparison. The Spearman correlation test will be used for correlation between the mindfulness scores and the stress, anxiety, depression, and burnout scores. 2-tailed p-values will be used.
- Conditions
- Stress, Anxiety, Depression, Mindfulness
- Being tested
- Mindfulness
- Keywords
- Mindfulness, Medical Students, Medical Residents, Medical Trainees
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness online training
| Study group | Role | What they receive |
|---|---|---|
| Pre-clerkship cohort | Experimental | First- and second-year medical students Receives: Behavioral: Mindfulness |
| Clerkship cohort | Experimental | Third- and fourth-year medical students Receives: Behavioral: Mindfulness |
| Resident cohort | Experimental | Medical residents Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress symptoms time 1
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to immediately after the online mindfulness course
Change in stress symptoms time 2
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to 3 months after the online mindfulness course
Change in anxiety symptoms time 1
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to immediately after the online mindfulness course
Change in anxiety symptoms time 2
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to 3 months after the online mindfulness course
Change in depression symptoms time 1
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to immediately after the online mindfulness course
Change in depression symptoms time 2
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
Measured: Change from recruitment to 3 months after the online mindfulness course
Change in burnout symptoms time 1
using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
Measured: Change from recruitment to immediately after the online mindfulness course
Change in burnout symptoms time 2
using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
Measured: Change from recruitment to 3 months after the online mindfulness course
Change in mindful awareness time 1
using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.
A high score in both scales (and subscales)means a high mindful awareness level.
Measured: Change from recruitment to immediately after the online mindfulness course
Change in mindful awareness time 2
using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.
A high score in both scales (and subscales)means a high mindful awareness level.
Measured: Change from recruitment to 3 months after the online mindfulness course
Secondary outcomes (4)
Frequency of Mindfulness practice 1
Frequency of mindfulness practice
Measured: From recruitment to the end of the online mindfulness elective (8 weeks in total)
Duration of Mindfulness practice 1
Duration of mindfulness practice
Measured: From recruitment to the end of the online mindfulness elective (8 weeks in total)
Frequency of Mindfulness practice 2
Frequency of mindfulness practice
Measured: From the end of the online mindfulness elective until three months after
Duration of Mindfulness practice 2
Duration of mindfulness practice
Measured: From the end of the online mindfulness elective until three months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 May 2021
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Why it stopped: The online mindfulness is no longer being offered and recruitment can no longer happen.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The three groups of participants are a pre-clerkship cohort consisting of first- and second-year medical students, a clerkship cohort consisting of third- and fourth-year medical students and the third cohort consisting of medical residents.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine Landry, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497909
- Sponsor's protocol ID
- Pro00103222
- Status last verified
- Sep 2023
- First submitted
- 30 Jul 2020
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Online Mindfulness on Depression, Anxiety, Stress and Burnout in Medical Students and Residents
- ClinicalTrials.gov ID
- NCT04497909
- Acronym / sponsor ID
- Pro00103222
- Conditions
- Stress, Anxiety, Depression, Mindfulness
- Keywords
- Mindfulness, Medical Students, Medical Residents, Medical Trainees
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The online mindfulness is no longer being offered and recruitment can no longer happen.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 4 Aug 2020 (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.
Medical students and medical residents are subject to increased stressors throughout their education. There is increased depression, anxiety, burnout, and distress in medical trainees compared to the general population. Globally, roughly 3 out of 10 medical students experience anxiety. A recent study also found that almost 3 out of 10 medical trainees experience depression or depressive symptoms and approximately 1 out of 10 have suicidal thoughts. All of this leads to poorer academics, increased dropout rates as well as reduced empathy and quality of care in affected trainees.
Mindfulness programs are increasingly being used in medical schools to help deal with increased levels of depression, anxiety, stress, and burnout. Several studies have looked at medical students, medical residents, and various other healthcare professionals. These programs have been found to reduce depression, anxiety and stress while significantly improving mood, well being and mindfulness.
Although in-person mindfulness programs have shown several benefits, there are limitations to its use in medical programs. A lack of time, flexibility, accessibility as well as the issue of cost, impact the uptake of in-person mindfulness programs. A potential alternative to this is online mindfulness programs. To date, there is limited research regarding medical students and online mindfulness programs. With that being said, studies focussed on other populations and online mindfulness have shown reductions in depression, anxiety and stress with improvements in mindfulness and mood.
The study being proposed involves providing online mindfulness to medical students and residents in an 8-week program that consists of 8, 1-hour sessions with a mindfulness coach. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of online mindfulness on anxiety, depression, stress and burnout. The results of this research may lead to future studies looking at the impact of online mindfulness practice for medical trainees and might also help open up the possibility of offering such programs in medical schools.
Detailed description
BACKGROUND
The transition to medical school and the subsequent years that follow are a period of increased stress on trainees. Research shows that there is a higher prevalence of depression, anxiety and burnout amongst U.S. and Canadian medical students compared to the general population. In addition, distress is consistently higher in medical trainees compared to the general population and in age matched non-medical students. A recent systematic review found the prevalence of depression or depressive symptoms in medical trainees to be 27.2% and suicidal ideation to be 11.1%. A separate systematic review found that the prevalence of anxiety in medical students was 33.8% globally. Increased levels of distress and anxiety lead to poorer academics and increased dropout rates, as well as a reduced empathy, enthusiasm, and quality of care.
An intervention that has been gaining traction in recent years to manage the psychological strain placed on medical trainees is mindfulness training. A study of 140 second year medical students participating in a 10-week mindfulness-based stress reduction program reported significant improvement in mood and reduced psychological distress. Similar results have been found in randomised controlled trials with health care professionals as well as surgical and psychiatric residents. Furthermore, a 2017 systematic review of 19 papers looking at the effectiveness of mindfulness interventions in healthcare professionals found them to decrease stress, anxiety and depression while improving mindfulness, empathy and mood. These benefits may potentially continue over the long term based on results from a 2018 longitudinal study of mindfulness training in medical and psychology students. At the six year follow up with the intervention group, they reported increased well being, mindfulness, and problem-focused coping.
Although in-person mindfulness training has shown several benefits, there are limitations to implementing these programs in the demanding schedules of medical trainees. In addition to a lack of time, flexibility, costs, anonymity, and accessibility may limit its effectiveness as well. A modality that may reduce these limitations is online mindfulness. This format allows flexibility with regards to when trainees would be able to access the material, it would be more cost effective and could be accessed from rural and remote areas as suggested in a 2020 pilot study completed with Australian rural medical students. Results indicated significant reduction in perceived stress and increases in self compassion 4 months after the 8-week online mindfulness program. Online mindfulness interventions have been studied in several other populations and a 2016 meta analysis of 15 randomised controlled trials, found online mindfulness interventions to reduce depression, anxiety, and stress with an associated increase in well being and mindfulness.
To date, there is limited research looking at online mindfulness as a tool for medical students and residents. The study being proposed here, would assess the impact of an online mindfulness intervention on medical trainees with regards to depression, anxiety, stress, burnout, and mindfulness.
OBJECTIVE
To explore the potential benefits of online mindfulness on depression, anxiety, stress, and burnout in medical trainees.
To explore the changes in mindfulness level over the course of an online mindfulness program offered to medical trainees.
HYPOTHESIS
The investigators hypothesize that medical students and residents that participate in the online mindfulness program will report reduced depression, stress, anxiety, and burnout as well as improved mindfulness.
MATERIALS AND METHODS
This study is a prospective observational study.
Procedure
Following recruitment, all participants will complete a general demographic form as well as four scales that measure depression, anxiety, stress, burnout, and mindfulness. The same four scales will be completed by all participants at the end of the mindfulness training and 3 months after the training.
Online Mindfulness Intervention (OMI)
All participants will be instructed by a mindfulness practitioner/coach online through 8, 1-hour sessions over the course of eight weeks. Trainees will have the ability to retrieve the online sessions at their convenience. Weekly journals will be provided to measure attendance and frequency and duration of mindfulness practice.
Instruments
General Demographic Form: A researcher created demographic data form (age, educational level, prior experience with mindfulness, history of depression and anxiety) to be completed by the medical trainees at enrolment.
Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be completed by the medical trainees at three time points.
Oldenburg Burnout Inventory for Students: 16 item scale to measure burnout in students completed at three time points.
Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto Mindfulness Scale will be completed by the medical trainees at three time points.
Mindfulness Weekly Journal: Document recording the duration and frequency of mindfulness practice during the study to assess attendance to the online class.
DATA ANALYSIS
Study data will be managed using Research Electronic Data Capture, a secure, web-based software platform, hosted at the University of Alberta. Group demographics will be compared with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group comparison. The Spearman correlation test will be used for correlation between the mindfulness scores and the stress, anxiety, depression, and burnout scores. 2-tailed p-values will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The three groups of participants are a pre-clerkship cohort consisting of first- and second-year medical students, a clerkship cohort consisting of third- and fourth-year medical students and the third cohort consisting of medical residents.
| Arm | Type | Receives |
|---|---|---|
| Pre-clerkship cohort | Experimental | Behavioral: MindfulnessFirst- and second-year medical students |
| Clerkship cohort | Experimental | Behavioral: MindfulnessThird- and fourth-year medical students |
| Resident cohort | Experimental | Behavioral: MindfulnessMedical residents |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A medical trainee who registered for the online mindfulness elective
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 |
|---|---|---|
| MindfulnessMindfulness online training | Behavioural | Clerkship cohort, Pre-clerkship cohort, Resident cohort |
Primary outcome
Change in stress symptoms time 1
Time frame: Change from recruitment to immediately after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
Change in stress symptoms time 2
Time frame: Change from recruitment to 3 months after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
Change in anxiety symptoms time 1
Time frame: Change from recruitment to immediately after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
Change in anxiety symptoms time 2
Time frame: Change from recruitment to 3 months after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
Change in depression symptoms time 1
Time frame: Change from recruitment to immediately after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
Change in depression symptoms time 2
Time frame: Change from recruitment to 3 months after the online mindfulness course
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
Change in burnout symptoms time 1
Time frame: Change from recruitment to immediately after the online mindfulness course
using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
Change in burnout symptoms time 2
Time frame: Change from recruitment to 3 months after the online mindfulness course
using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
Change in mindful awareness time 1
Time frame: Change from recruitment to immediately after the online mindfulness course
using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.
Change in mindful awareness time 2
Time frame: Change from recruitment to 3 months after the online mindfulness course
using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.
4 secondary outcomes
Frequency of Mindfulness practice 1
Time frame: From recruitment to the end of the online mindfulness elective (8 weeks in total)
Duration of Mindfulness practice 1
Time frame: From recruitment to the end of the online mindfulness elective (8 weeks in total)
Frequency of Mindfulness practice 2
Time frame: From the end of the online mindfulness elective until three months after
Duration of Mindfulness practice 2
Time frame: From the end of the online mindfulness elective until three months after
Results and safety
The study was stopped early (reason given: The online mindfulness is no longer being offered and recruitment can no longer happen.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
Marc-Antoine Landry, MD principal investigator
University of Alberta
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 in people with Stress and Anxiety, run by University of Alberta at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 13 Sep 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 Canada. 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 was stopped early (reason given: The online mindfulness is no longer being offered and recruitment can no longer happen.). Results are not available in the source record.
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?
Change in stress symptoms time 1 (time frame: Change from recruitment to immediately after the online mindfulness course). The study lists 10 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 13 Sep 2023.