Burnout, ProfessionalPSTNCT02544412
A Well-being Training for Preservice Teachers
A study testing novel mindfulness-based well-being training in people with Burnout, Professional and Stress, Psychological, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this project is to study whether a mindfulness-based training program supports self-regulation, resiliency, effective classroom behaviors, and persistence in teaching. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Psychological, Well-being
- What is being tested?
- novel mindfulness-based well-being training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 11 Dec 2020
- 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
- Undergraduate students in good academic standing entering their third semester of one of the following teacher education certificate programs (Early Education ESL, Middle Education SPED, Middle Education Content, Middle Education ESL). Note that good academic standing is a requirement for continuation in the certification program.
Who cannot join
- A history of schizophrenia-spectrum, bipolar disorder, or other psychotic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Madison Department of Curriculum and Instruction
Madison, Wisconsin, 53706
About this study
The purpose of this project is to study whether a mindfulness-based training program supports self-regulation, resiliency, effective classroom behaviors, and persistence in teaching.
Read the detailed description
Participants in this study will be undergraduate pre-service teachers already enrolled in the Early Elementary Certification Program (EECP) in the School of Education. This competitive admission program is four semesters long and consists of 4 certificate granting areas. Over the course of 2 years (i.e., 4 semesters), the investigators will recruit a total of 8 cohorts; 2 from each certificate granting area. Participants will be recruited during their second semester in the program for enrollment during the third semester (i.e., enrollment first semester of senior year). Cohorts will be match randomized by cohort type, ensuring that 4 cohorts are randomized to treatment and 4 cohorts are randomized to teacher education as usual, and that one of each type of cohort is randomized to treatment and control, respectively.
All participants will complete a battery of self-report and behavioral tasks, as well as undergo a standardized classroom observation prior to the start of the intervention, immediately after the intervention, and at follow-up (5-8 months post intervention). Follow-up testing will occur during the final month of the final semester in the EECP program, a time during which participants will be full-time student teaching, training that best approximates in-service teaching. The qualitative component of this study will involve participants partaking in approximately four-hours of interviews (either group or individual based on a hierarchal sampling criterion), before and after the intervention period. In addition, all student EECP records will be qualitatively analyzed (i.e., supervisor notes, state certification portfolios). Each September for three years post-graduation, participants will be contacted and instructed to complete an online survey consisting of self-report inventories and information about whether they are continuing to teach and if so, the name and district of the school they currently work.
Participants randomized to treatment will receive 1.5 hours of mindfulness training for 8 to 10 weeks during their third semester. Thirty minutes of this will occur during mandatory cohort seminar time, with the remaining one-hour after the end of cohort seminar time. In addition, during the intervention period they will participate in two 4-hour "Days of Mindfulness." In total, intervention participants will receive about 21 hours of instruction in mindfulness over the intervention period. During the following semester (4th semester), intervention participants will receive 15 minutes of mindfulness "booster" practice each week as part of their mandatory cohort seminar.
This novel mindfulness based intervention is incorporates elements of Mindfulness Based Stress Reduction (Kabat-Zinn, 1982), as well as contemplative practices that might be defined as social connectedness practices or constructivist practices (Dahl, Lutz, \& Davidson, 2015). The curriculum has been developed by experienced mindfulness teachers (>10 years teaching experience, on average), all of whom have extensive meditation histories and most of whom have long-term experience as classroom teachers. The training will consist of formal and informal mindfulness meditation practices.
- Conditions
- Burnout, Professional, Stress, Psychological, Well-being, Psychological Adjustment, Self-regulation
- Being tested
- novel mindfulness-based well-being training
- Keywords
- Mindfulness, School Teachers, preservice teachers, teacher education
- Medical subject headings
- Burnout, Professional, Stress, Psychological, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel mindfulness-based well-being trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A novel mindfulness-based well-being training for preservice teachers will be employed. The intervention will be held once a week for 8-10 weeks. Two 4-hour "days of mindfulness" will also be implemented during the intervention period. The intervention will involve training in a range of attentional and constructive (Dahl, Lutz, \& Davidson) contemplative practices. During the follow-up period participants will receive weekly 15 minute "booster" trainings. Receives: Behavioral: novel mindfulness-based well-being training |
| Control Group | No intervention | Teacher education as usual. These participants will continue with the prescribed teacher training regime established by the Early Education Certification Program at the university. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on CLASS assessment tool (La Paro, Pianta, & Stuhlman, 2004)
A standardized classroom observation tool assessing teacher classroom behaviors.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Symptoms Checklist 90 Revised (Derogatis, 1994)
a 90-item self-report of psychological symptoms comprised of 9 symptom axes (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). An aggregated score across all 9 domains provides a Global Severity Index score of psychological health.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Maslach Burnout Inventory - Education Survey (Maslach, Jackson, & Leiter, 1996)
a 22-item self-report of teaching related burnout
Measured: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on Emotional go/nogo (Hare et al., 2008)
An emotional inhibition paradigm.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Persistence in teaching: Current profession and role (if teaching, name of school)
Self-report on employment status following graduation and teacher licensure.
Measured: ~ 14 months after baseline, ~ 26 months after baseline, and ~ 38 months after baseline.
Secondary outcomes (10)
Change from baseline on Implicit Positive and Negative Affect Test (Quirin, Kazen, & Kuhl, 2009)
A computer-based behavioral measure of implicit affective bias in which participants are provided with 5 nonsense words and asked to rate the words on a scale of emotional valence.
Measured: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on General Self-efficacy Scale (Jerusalem & Schwarzer, 1992)
A 10-item self-report of general self-efficacy
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Psychological Well-Being Scale (Ryff & Keyes, 1995)
A 54-item self-report inventory assessing psychological well-being.
Measured: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
A self-report survey of general positive and negative affect.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Emotional Styles Questionnaire (under development)
A self-report designed to assess styles of emotional responding.
Measured: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on Open response on difficulties in teaching
A one-item open response on difficulty in teaching.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
A 10-item self-report on perceived stress in the last month.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Implicit Association Task (Race, child and adult versions; Baron & Banaji, 2006)
A behavioral task designed to assess implicit biases related to race.
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Five Facet Mindfulness Questionnaire (Baer et al., 2008)
A 39-item self-report of mindfulness
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Breath Count Task (Levinson et al., 2014)
15 minute behavioral measure of mindfulness
Measured: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion14 Dec 2017
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 Wisconsin, MadisonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, The Trust for the Meditation Process
- Responsible party
- Sponsor
- Investigators
- Lisa Flook, PhD, Principal investigator, University of Wisconsin, MadisonMatthew J Hirshberg, PhD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544412
- Sponsor's protocol ID
- 2014-1263
- Other IDs
- A487400, L&S/PSYCHOLOGY/PSYCHOLOGY
- Acronym
- PST
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2015
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
PubMed 7042457La Paro, K. M., Pianta, R. C., & Stuhlman, M. (2004). The Classroom Assessment Scoring System: Findings from the prekindergarten year. The Elementary School Journal, 104(5), 409-426. http://doi.org/10.1086/499760
Levinson DB, Stoll EL, Kindy SD, Merry HL, Davidson RJ. A mind you can count on: validating breath counting as a behavioral measure of mindfulness. Front Psychol. 2014 Oct 24;5:1202. doi: 10.3389/fpsyg.2014.01202. eCollection 2014.
PubMed 25386148Dahl CJ, Lutz A, Davidson RJ. Reconstructing and deconstructing the self: cognitive mechanisms in meditation practice. Trends Cogn Sci. 2015 Sep;19(9):515-23. doi: 10.1016/j.tics.2015.07.001. Epub 2015 Jul 28.
PubMed 26231761Derogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.
Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual . Mountain View, CA: CPP. Inc., and Davies-Black.
Baron AS, Banaji MR. The development of implicit attitudes. Evidence of race evaluations from ages 6 and 10 and adulthood. Psychol Sci. 2006 Jan;17(1):53-8. doi: 10.1111/j.1467-9280.2005.01664.x.
PubMed 16371144Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
PubMed 18310597Quirin M, Kazen M, Kuhl J. When nonsense sounds happy or helpless: The Implicit Positive and Negative Affect Test (IPANAT). J Pers Soc Psychol. 2009 Sep;97(3):500-16. doi: 10.1037/a0016063.
PubMed 19686004Jerusalem, M., & Schwarzer, R. (1992). Self-efficacy as a resource factor in stress appraisal processes. Self-efficacy: Thought control of action, 195-213.
Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.
PubMed 7473027Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Hare TA, Tottenham N, Galvan A, Voss HU, Glover GH, Casey BJ. Biological substrates of emotional reactivity and regulation in adolescence during an emotional go-nogo task. Biol Psychiatry. 2008 May 15;63(10):927-34. doi: 10.1016/j.biopsych.2008.03.015.
PubMed 18452757
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Well-being Training for Preservice Teachers
- ClinicalTrials.gov ID
- NCT02544412
- Acronym / sponsor ID
- PST / 2014-1263
- Conditions
- Burnout, Professional, Stress, Psychological, Well-being, Psychological Adjustment, Self-regulation
- Keywords
- Mindfulness, School Teachers, preservice teachers, teacher education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, The Trust for the Meditation Process
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 9 Sep 2015 (estimated)
- 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 purpose of this project is to study whether a mindfulness-based training program supports self-regulation, resiliency, effective classroom behaviors, and persistence in teaching.
Detailed description
Participants in this study will be undergraduate pre-service teachers already enrolled in the Early Elementary Certification Program (EECP) in the School of Education. This competitive admission program is four semesters long and consists of 4 certificate granting areas. Over the course of 2 years (i.e., 4 semesters), the investigators will recruit a total of 8 cohorts; 2 from each certificate granting area. Participants will be recruited during their second semester in the program for enrollment during the third semester (i.e., enrollment first semester of senior year). Cohorts will be match randomized by cohort type, ensuring that 4 cohorts are randomized to treatment and 4 cohorts are randomized to teacher education as usual, and that one of each type of cohort is randomized to treatment and control, respectively.
All participants will complete a battery of self-report and behavioral tasks, as well as undergo a standardized classroom observation prior to the start of the intervention, immediately after the intervention, and at follow-up (5-8 months post intervention). Follow-up testing will occur during the final month of the final semester in the EECP program, a time during which participants will be full-time student teaching, training that best approximates in-service teaching. The qualitative component of this study will involve participants partaking in approximately four-hours of interviews (either group or individual based on a hierarchal sampling criterion), before and after the intervention period. In addition, all student EECP records will be qualitatively analyzed (i.e., supervisor notes, state certification portfolios). Each September for three years post-graduation, participants will be contacted and instructed to complete an online survey consisting of self-report inventories and information about whether they are continuing to teach and if so, the name and district of the school they currently work.
Participants randomized to treatment will receive 1.5 hours of mindfulness training for 8 to 10 weeks during their third semester. Thirty minutes of this will occur during mandatory cohort seminar time, with the remaining one-hour after the end of cohort seminar time. In addition, during the intervention period they will participate in two 4-hour "Days of Mindfulness." In total, intervention participants will receive about 21 hours of instruction in mindfulness over the intervention period. During the following semester (4th semester), intervention participants will receive 15 minutes of mindfulness "booster" practice each week as part of their mandatory cohort seminar.
This novel mindfulness based intervention is incorporates elements of Mindfulness Based Stress Reduction (Kabat-Zinn, 1982), as well as contemplative practices that might be defined as social connectedness practices or constructivist practices (Dahl, Lutz, \& Davidson, 2015). The curriculum has been developed by experienced mindfulness teachers (>10 years teaching experience, on average), all of whom have extensive meditation histories and most of whom have long-term experience as classroom teachers. The training will consist of formal and informal mindfulness meditation practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: novel mindfulness-based well-being trainingA novel mindfulness-based well-being training for preservice teachers will be employed. The intervention will be held once a week for 8-10 weeks. Two 4-hour "days of mindfulness" will also be implemented during the intervention period. The intervention will involve training in a range of attentional and constructive (Dahl, Lutz, \& Davidson) contemplative practices. During the follow-up period participants will receive weekly 15 minute "booster" trainings. |
| Control Group | No intervention | –Teacher education as usual. These participants will continue with the prescribed teacher training regime established by the Early Education Certification Program at the university. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergraduate students in good academic standing entering their third semester of one of the following teacher education certificate programs (Early Education ESL, Middle Education SPED, Middle Education Content, Middle Education ESL). Note that good academic standing is a requirement for continuation in the certification program.
Key exclusion criteria (1 listed)
- A history of schizophrenia-spectrum, bipolar disorder, or other psychotic disorders
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 |
|---|---|---|
| novel mindfulness-based well-being training | Behavioural | Intervention Group |
Primary outcome
Change from baseline on CLASS assessment tool (La Paro, Pianta, & Stuhlman, 2004)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
A standardized classroom observation tool assessing teacher classroom behaviors.
Change from baseline on Symptoms Checklist 90 Revised (Derogatis, 1994)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
a 90-item self-report of psychological symptoms comprised of 9 symptom axes (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). An aggregated score across all 9 domains provides a Global Severity Index score of psychological health.
Change from baseline on Maslach Burnout Inventory - Education Survey (Maslach, Jackson, & Leiter, 1996)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
a 22-item self-report of teaching related burnout
Change from baseline on Emotional go/nogo (Hare et al., 2008)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
An emotional inhibition paradigm.
Persistence in teaching: Current profession and role (if teaching, name of school)
Time frame: ~ 14 months after baseline, ~ 26 months after baseline, and ~ 38 months after baseline.
Self-report on employment status following graduation and teacher licensure.
10 secondary outcomes
Change from baseline on Implicit Positive and Negative Affect Test (Quirin, Kazen, & Kuhl, 2009)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on General Self-efficacy Scale (Jerusalem & Schwarzer, 1992)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Psychological Well-Being Scale (Ryff & Keyes, 1995)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Emotional Styles Questionnaire (under development)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11-12 weeks after baseline (1-2 weeks post-intervention), 8-11 months after baseline (5-8 months post-intervention): ~14 months after baseline, ~26 months after baseline, and ~38 months after baseline
Change from baseline on Open response on difficulties in teaching
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Implicit Association Task (Race, child and adult versions; Baron & Banaji, 2006)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Five Facet Mindfulness Questionnaire (Baer et al., 2008)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Change from baseline on Breath Count Task (Levinson et al., 2014)
Time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 7042457Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
- BackgroundLa Paro, K. M., Pianta, R. C., & Stuhlman, M. (2004). The Classroom Assessment Scoring System: Findings from the prekindergarten year. The Elementary School Journal, 104(5), 409-426. http://doi.org/10.1086/499760
- Background: PubMed 25386148Levinson DB, Stoll EL, Kindy SD, Merry HL, Davidson RJ. A mind you can count on: validating breath counting as a behavioral measure of mindfulness. Front Psychol. 2014 Oct 24;5:1202. doi: 10.3389/fpsyg.2014.01202. eCollection 2014.
- Background: PubMed 26231761Dahl CJ, Lutz A, Davidson RJ. Reconstructing and deconstructing the self: cognitive mechanisms in meditation practice. Trends Cogn Sci. 2015 Sep;19(9):515-23. doi: 10.1016/j.tics.2015.07.001. Epub 2015 Jul 28.
- BackgroundDerogatis, L. R. (1994). SCL-90-R Symptom Checklist-90-R administration, scoring and procedures manual. Minneapolis, MN: National Computer Systems.
- BackgroundMaslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual . Mountain View, CA: CPP. Inc., and Davies-Black.
- Background: PubMed 16371144Baron AS, Banaji MR. The development of implicit attitudes. Evidence of race evaluations from ages 6 and 10 and adulthood. Psychol Sci. 2006 Jan;17(1):53-8. doi: 10.1111/j.1467-9280.2005.01664.x.
- Background: PubMed 18310597Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
- Background: PubMed 19686004Quirin M, Kazen M, Kuhl J. When nonsense sounds happy or helpless: The Implicit Positive and Negative Affect Test (IPANAT). J Pers Soc Psychol. 2009 Sep;97(3):500-16. doi: 10.1037/a0016063.
- BackgroundJerusalem, M., & Schwarzer, R. (1992). Self-efficacy as a resource factor in stress appraisal processes. Self-efficacy: Thought control of action, 195-213.
- Background: PubMed 7473027Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
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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.
Lisa Flook, PhD principal investigator
University of Wisconsin, Madison
Matthew J Hirshberg, PhD study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel mindfulness-based well-being training in people with Burnout, Professional and Stress, Psychological, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. 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 United States. 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?
Change from baseline on CLASS assessment tool (La Paro, Pianta, & Stuhlman, 2004) (time frame: 1-2 weeks before intervention (i.e., baseline), 11 - 12 weeks after baseline (1-2 weeks post-intervention), 8 - 11 months after baseline ( 5-8 months post intervention)). The study lists 5 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 NCT02544412, which also lists 14 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 26 Jan 2021.