Burnout, ProfessionalNCT04586309
Improving the Mental Health of Resident Physicians and Fellows Through Transcendental Meditation
A study testing Transcendental meditation in people with Burnout, Professional and Stress, Psychological, run by University of Arizona.
Trial summary
This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Psychological, Depression
- What is being tested?
- Transcendental meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2021
- 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
- Full-time Resident physicians or Fellows employed by Banner Health
- 18 years or older
- Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated.
- Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training)
- Willing to complete baseline, 1-month and 3-month post- assessments
- If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment (by self-report).
Who cannot join
- Already instructed in the Transcendental Meditation technique
- Currently unstable psychotic symptoms, mania or bipolar disorder as demonstrated by self-report, or psychiatric hospitalizations in the past six months;
- Current suicidal or homicidal ideation with intent or plan.
About this study
Official title: Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation
This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). It is particularly timely due to the enormous pressure and stress that residents face as front-line workers during the current 2019 novel coronavirus (COVID-19) pandemic.
Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.
These assessment tools look at anxiety (Generalized Anxiety Disorder Scale-GAD-7), depression (Patient Health Questionnaire (PHQ-9), insomnia (Pittsburgh Sleep Quality Index PSQI), psychological distress (Brief Symptom Inventory BSI18), burnout (Maslach Burnout Inventory-MBI), resilience (Conner-Davidson Resilience Scale- RISC), and alcohol use (Alcohol Use Disorder Identification Test - AUDIT).
Read the detailed description
Up to one hundred resident and fellow physicians employed by Banner Health will participate in the project. Participants will be randomly assigned to either the TM program or to a delayed TM training, treatment-as-usual control group . Study outcomes will be assessed at baseline, 1-month and 3-month post-training , with change in burnout as the primary outcome. Control subjects (aka delayed TM training or Group 2) will be eligible to learn TM after completing 3 month post-testing. Group 2 will also complete post-training assessments at 1-month and 3-months post-training. The total duration of this project will be 60 months.
Two experienced certified TM instructors will conduct the instruction. All certified TM teachers have been extensively trained in the teaching of the TM program, including teaching the course of instruction, verifying continued correctness of effortless practice of the technique, and conducting additional follow-up sessions. The same standardized TM course sequence will be used for all study participants.
Outline of Transcendental Meditation Program: TM group will involve 10 total sessions over 12 weeks (about 75 minutes per session). The core instruction in the TM technique will involve a course of instruction, taught over five sessions. The five core instruction sessions will include:
- Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique(75 minutes- group session); After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. The participant completes a brief interview form prior to the call. The interviewer (a teacher with the TM program) reviews the form with the participant. The four classes of TM instruction adhere to a standardized teaching protocol and are conducted by certified teachers of the Transcendental Meditation program trained and approved by the Transcendental Meditation organization.
- Personal Instruction-individual one-on-one instruction in the TM technique (75 minutes). The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
- First Day of Verification of Correct Practice and Further Instruction (90 minutes-group session); The first follow-up session provides information to help students incorporate TM into their daily life.
- Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences (90 minutes-group session); The second session provides information about how the meditation reduces stress and improves health
- Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness (90 minutes-group session). The third session reviews students' experiences both during and after meditation, and provides further instruction to support their ongoing home practice.
Following the initial phase of the intervention (5 sessions), there will be 5 additional group sessions of 45-60minutes each provided once a month for the remainder of the 6-month intervention period. These sessions will include: a) discussion of personal experiences and verification of correctness of practice of the TM technique, and b) knowledge of the human potential and its relationship to mental and physical health.
Compliance with treatment sessions will be defined as attending at least 70% of the treatment sessions. Subjects randomized to the TM group will continue with their usual care.
No research data is collected during the sessions described above.
Although it is the intent for all of these sessions to be conducted at the Tucson Transcendental Meditation Center, in small physically distanced groups of participants wearing whatever level of personal protective equipment is being recommended by the CD at the time of the session, in the event that in person sessions are not possible, the group sessions will be held virtually through Zoom video conferencing. Additionally, participants may be able to complete sessions 3-5 over the TM App (a series of pre-recorded lectures).
For participants who choose to use the TM App, they will be asked to create an account through the app, and will be given the opportunity to review the Terms of Service and Privacy Policies. Maharishi Foundation International (the owners/developers of the App) monitor the participants progress through the digital content so that they know when to release the next session (as described above). Participants can also use the App to time their meditation sessions, although this is not required.
Home Practice: Home practice will consist of two 20-minute TM sessions daily - morning and evening. Compliance with TM practice will be defined as meditating at least once a day. Participants will complete a home practice questionnaire at 1 month and 3 months (attached as an addendum-will be included in the REDCap bundle with assessments).
Delayed TM training/Control Condition: Subjects randomized to the control group will continue with their usual care. Control subjects will be invited to learn the TM program after 3-month post-training assessment. If they chose to complete the TM training, they will be subject to the same training as Group 1, and the same assessments after the end of their training.
- Conditions
- Burnout, Professional, Stress, Psychological, Depression, Job Stress
- Being tested
- Transcendental meditation
- Keywords
- transcendental meditation, resilience, burnout
- Medical subject headings
- Burnout, Professional, Stress, Psychological, Depression, Occupational Stress, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental meditationBehavioural
Instruction in the TM technique is taught over five sessions.
- Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program.
- Personal Instruction-individual one-on-one instruction in the TM technique. The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
- First Day of Verification of Correct Practice and Further Instruction.
- Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences.
- Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness.
| Study group | Role | What they receive |
|---|---|---|
| Early TM Training | Experimental | This group will receive training in Transcendental Meditation and will complete assessments at baseline, 1 month and 3 months.(3 assessments in total). Receives: Behavioral: Transcendental meditation |
| Delayed TM training | Active comparator | This arm will complete the baseline, 1 month and 3 month assessments and then will receive the TM training, followed by additional 1 month and 3 month post-training assessments (5 in total) Receives: Behavioral: Transcendental meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
Measured: baseline
Burnout
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
Measured: 1 month
Burnout
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
Measured: 3 month
Secondary outcomes (18)
Resilience
Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.
Measured: baseline
Resilience
Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.
Measured: 1 month
Resilience
Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.
Measured: 3 months
Alcohol use
AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.
Measured: baseline
Alcohol use
AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.
Measured: 1 month
Alcohol use
AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.
Measured: 3 months
Depression
PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.
Measured: baseline
Depression
PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.
Measured: 1 month
Depression
PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.
Measured: 3 months
Sleep Quality
PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.
Measured: baseline
Sleep Quality
PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.
Measured: 1 month
Sleep Quality
PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.
Measured: 3 months
Distress
BSI18: Brief Symptom Inventory 18- Participants answer 18 questions on 0-4 scale. Higher numbers indicate more distress.
Measured: baseline
Distress
BSI18: Brief Symptom Inventory 18
Measured: 1 month
Distress
BSI18: Brief Symptom Inventory 18
Measured: 3 months
Anxiety
GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,
Measured: baseline
Anxiety
GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,
Measured: 1 month
Anxiety
GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- David Lynch Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586309
- Sponsor's protocol ID
- 2008969193
- Status last verified
- Sep 2021
- First submitted
- 2 Oct 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
PubMed 32202646Valosek L, Link J, Mills P, Konrad A, Rainforth M, Nidich S. Effect of Meditation on Emotional Intelligence and Perceived Stress in the Workplace: A Randomized Controlled Study. Perm J. 2018;22:17-172. Published 2018 Oct 29. doi:10.7812/TPP/17-172
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation
- ClinicalTrials.gov ID
- NCT04586309
- Acronym / sponsor ID
- 2008969193
- Conditions
- Burnout, Professional, Stress, Psychological, Depression, Job Stress
- Keywords
- transcendental meditation, resilience, burnout
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- David Lynch Foundation
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Oct 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.
This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). It is particularly timely due to the enormous pressure and stress that residents face as front-line workers during the current 2019 novel coronavirus (COVID-19) pandemic.
Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.
These assessment tools look at anxiety (Generalized Anxiety Disorder Scale-GAD-7), depression (Patient Health Questionnaire (PHQ-9), insomnia (Pittsburgh Sleep Quality Index PSQI), psychological distress (Brief Symptom Inventory BSI18), burnout (Maslach Burnout Inventory-MBI), resilience (Conner-Davidson Resilience Scale- RISC), and alcohol use (Alcohol Use Disorder Identification Test - AUDIT).
Detailed description
Up to one hundred resident and fellow physicians employed by Banner Health will participate in the project. Participants will be randomly assigned to either the TM program or to a delayed TM training, treatment-as-usual control group . Study outcomes will be assessed at baseline, 1-month and 3-month post-training , with change in burnout as the primary outcome. Control subjects (aka delayed TM training or Group 2) will be eligible to learn TM after completing 3 month post-testing. Group 2 will also complete post-training assessments at 1-month and 3-months post-training. The total duration of this project will be 60 months.
Two experienced certified TM instructors will conduct the instruction. All certified TM teachers have been extensively trained in the teaching of the TM program, including teaching the course of instruction, verifying continued correctness of effortless practice of the technique, and conducting additional follow-up sessions. The same standardized TM course sequence will be used for all study participants.
Outline of Transcendental Meditation Program: TM group will involve 10 total sessions over 12 weeks (about 75 minutes per session). The core instruction in the TM technique will involve a course of instruction, taught over five sessions. The five core instruction sessions will include:
- Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique(75 minutes- group session); After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. The participant completes a brief interview form prior to the call. The interviewer (a teacher with the TM program) reviews the form with the participant. The four classes of TM instruction adhere to a standardized teaching protocol and are conducted by certified teachers of the Transcendental Meditation program trained and approved by the Transcendental Meditation organization.
- Personal Instruction-individual one-on-one instruction in the TM technique (75 minutes). The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
- First Day of Verification of Correct Practice and Further Instruction (90 minutes-group session); The first follow-up session provides information to help students incorporate TM into their daily life.
- Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences (90 minutes-group session); The second session provides information about how the meditation reduces stress and improves health
- Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness (90 minutes-group session). The third session reviews students' experiences both during and after meditation, and provides further instruction to support their ongoing home practice.
Following the initial phase of the intervention (5 sessions), there will be 5 additional group sessions of 45-60minutes each provided once a month for the remainder of the 6-month intervention period. These sessions will include: a) discussion of personal experiences and verification of correctness of practice of the TM technique, and b) knowledge of the human potential and its relationship to mental and physical health.
Compliance with treatment sessions will be defined as attending at least 70% of the treatment sessions. Subjects randomized to the TM group will continue with their usual care.
No research data is collected during the sessions described above.
Although it is the intent for all of these sessions to be conducted at the Tucson Transcendental Meditation Center, in small physically distanced groups of participants wearing whatever level of personal protective equipment is being recommended by the CD at the time of the session, in the event that in person sessions are not possible, the group sessions will be held virtually through Zoom video conferencing. Additionally, participants may be able to complete sessions 3-5 over the TM App (a series of pre-recorded lectures).
For participants who choose to use the TM App, they will be asked to create an account through the app, and will be given the opportunity to review the Terms of Service and Privacy Policies. Maharishi Foundation International (the owners/developers of the App) monitor the participants progress through the digital content so that they know when to release the next session (as described above). Participants can also use the App to time their meditation sessions, although this is not required.
Home Practice: Home practice will consist of two 20-minute TM sessions daily - morning and evening. Compliance with TM practice will be defined as meditating at least once a day. Participants will complete a home practice questionnaire at 1 month and 3 months (attached as an addendum-will be included in the REDCap bundle with assessments).
Delayed TM training/Control Condition: Subjects randomized to the control group will continue with their usual care. Control subjects will be invited to learn the TM program after 3-month post-training assessment. If they chose to complete the TM training, they will be subject to the same training as Group 1, and the same assessments after the end of their training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.
| Arm | Type | Receives |
|---|---|---|
| Early TM Training | Experimental | Behavioral: Transcendental meditationThis group will receive training in Transcendental Meditation and will complete assessments at baseline, 1 month and 3 months.(3 assessments in total). |
| Delayed TM training | Active comparator | Behavioral: Transcendental meditationThis arm will complete the baseline, 1 month and 3 month assessments and then will receive the TM training, followed by additional 1 month and 3 month post-training assessments (5 in total) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Full-time Resident physicians or Fellows employed by Banner Health
- 18 years or older
- Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated.
- Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training)
- Willing to complete baseline, 1-month and 3-month post- assessments
Key exclusion criteria (3 listed)
- Already instructed in the Transcendental Meditation technique
- Currently unstable psychotic symptoms, mania or bipolar disorder as demonstrated by self-report, or psychiatric hospitalizations in the past six months;
- Current suicidal or homicidal ideation with intent or plan.
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 |
|---|---|---|
| Transcendental meditationInstruction in the TM technique is taught over five sessions. 1. Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. 2. Personal Instruction-individual one-on-one instruction in the TM technique. The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly. 3. First Day of Verification of Correct Practice and Further Instruction. 4. Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences. 5. Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness. | Behavioural | Delayed TM training, Early TM Training |
Primary outcome
Burnout
Time frame: baseline
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
Burnout
Time frame: 1 month
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
Burnout
Time frame: 3 month
Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.
18 secondary outcomes
Resilience
Time frame: baseline
Resilience
Time frame: 1 month
Resilience
Time frame: 3 months
Alcohol use
Time frame: baseline
Alcohol use
Time frame: 1 month
Alcohol use
Time frame: 3 months
Depression
Time frame: baseline
Depression
Time frame: 1 month
Depression
Time frame: 3 months
Sleep Quality
Time frame: baseline
Sleep Quality
Time frame: 1 month
Sleep Quality
Time frame: 3 months
Distress
Time frame: baseline
Distress
Time frame: 1 month
Distress
Time frame: 3 months
Anxiety
Time frame: baseline
Anxiety
Time frame: 1 month
Anxiety
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 32202646Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
- BackgroundValosek L, Link J, Mills P, Konrad A, Rainforth M, Nidich S. Effect of Meditation on Emotional Intelligence and Perceived Stress in the Workplace: A Randomized Controlled Study. Perm J. 2018;22:17-172. Published 2018 Oct 29. doi:10.7812/TPP/17-172
- Information from David Lynch Foundation regarding grantLink provided by the sponsor.
- Information about transcendental meditation and other TM researchLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental meditation in people with Burnout, Professional and Stress, Psychological, run by University of Arizona.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586309, which also lists 2 linked publications.
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 1 Oct 2021.