BurnoutNCT07848230
From Burnout to Balance: Implementing a Theory-Driven Resiliency Program in Occupational Therapy Doctoral Education
A study testing Mauna Model Resiliency Program in people with Burnout and Burnout Syndrome, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this study is to learn about burnout among first-year Occupational Therapy Doctoral (OTD) students and how it may affect their mental health, daily activities, and overall well-being. Students will be asked questions about their stress levels, daily habits, and experiences in school. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burnout, Burnout Syndrome, Burnout Among Occupational Therapists
- What is being tested?
- Mauna Model Resiliency Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrolled as a first-year student in the Doctor of Occupational Therapy (OTD) program at Nova Southeastern University Tampa Bay Regional Campus (NSU-TBRC)
- 18 years of age or older
- Able to read and understand English, as all materials will be administered in English
- Willing to provide informed consent and participate in study procedures including surveys, reflection activities, and optional focus groups
Who cannot join
- Not enrolled in the NSU-TBRC OTD program as a first year student
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Clearwater, Florida, 33759-4514
About this study
The purpose of this study is to learn about burnout among first-year Occupational Therapy Doctoral (OTD) students and how it may affect their mental health, daily activities, and overall well-being. Students will be asked questions about their stress levels, daily habits, and experiences in school. The study will also evaluate a resilience program that is built into a hybrid OTD curriculum to see whether it helps students manage stress, improve their well-being, perform well academically, and support their long-term success. Researchers will look for patterns in the responses to better understand student experiences. The findings may help occupational therapy programs and other healthcare schools provide better support for students.
Read the detailed description
Burnout among occupational therapy (OT) students is a growing concern and has been reported at rates approaching 80%, exceeding those observed in the general student population. Contributing factors include demanding academic coursework, fieldwork preparation, financial pressures, role transitions, and limited access to effective coping resources. Burnout during professional education has been associated with decreased academic performance, poorer mental health outcomes, reduced engagement, and long-term professional strain. Despite these concerns, structured and evidence-based wellness interventions are not routinely integrated into occupational therapy curricula.
This pilot study aims to evaluate the feasibility and preliminary effectiveness of a curriculum-integrated resiliency program based on the Mauna Model for entry-level Doctor of Occupational Therapy (OTD) students enrolled in a hybrid educational program. The Mauna Model emphasizes achieving balance among personal, professional, and environmental factors to support well-being and resilience. The intervention is further informed by the Model of Human Occupation (MOHO), which recognizes the interaction between personal capacities, habits, values, and environmental influences in shaping occupational participation and health.
The study responds to emerging evidence indicating that occupational therapy students often rely on inadequate coping strategies and may benefit from intentional, evidence-based approaches to developing resilience and self-management skills. By introducing resiliency-building activities early in the educational experience, the program seeks to support students' well-being, reduce burnout risk, and promote academic and professional success.
The primary objective is to determine the feasibility, acceptability, and preliminary effectiveness of integrating a Mauna Model-based resiliency program into a hybrid OTD curriculum. Feasibility outcomes will include recruitment, retention, participation rates, and participant satisfaction. Secondary outcomes include changes in burnout, resilience, and perceived well-being. Findings from this pilot study will provide foundational data for larger-scale investigations and may inform the development of sustainable wellness initiatives within occupational therapy education programs. The long-term goal is to support student well-being, academic success, professional readiness, and workforce sustainability by reducing burnout and strengthening resilience among future occupational therapy practitioners
- Conditions
- Burnout, Burnout Syndrome, Burnout Among Occupational Therapists, Burnout, Student, Burnout，Motivation，Stress，Mental Toughness
- Being tested
- Mauna Model Resiliency Program
- Keywords
- Burnout, Burnout Syndrome, Burnout, Student, Occupational Therapy, Hybrid Learning, Doctoral Education, Resilience, Healthcare Student Resilience, Burnout among occupational therapy students, Building resilience in occupational therapy students
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mauna Model Resiliency ProgramBehavioural
"Mauna" is a term for mountain. The program uses a mountain hike metaphor to represent the career journey, it emphasizes self-reflection, competency development, and mentorship to build confidence and resilience during transitions such as the shift from student to practitioner. Unlike client-focused models, the Mauna Model supports professional growth by helping OT students and practitioners identify, develop, and reflect on core competencies
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Other | The study only involves one group of student participants and will participate in the Mauna Model Resiliency Program Receives: Behavioral: Mauna Model Resiliency Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory-Student Survey (MBI-SS)
The Maslach Burnout Inventory-Student Survey (MBI-SS) will be used to measure academic burnout among participants. The MBI-SS assesses three key components of burnout: emotional exhaustion, cynicism or depersonalization, and reduced personal accomplishment. Participants rate the frequency of burnout-related experiences on a Likert scale. This instrument is widely used in research involving students and healthcare professionals and has demonstrated strong validity and reliability
Measured: From enrollment to the end of program at 41 weeks
Mauna Model Compass
The Mauna Model Self-Rating Scale Compass will be used to assess participants' perceived competencies related to professional development and resilience. This scale allows participants to reflect on areas such as interpersonal skills, intrapersonal development, technical competence, ethical practice, and occupational balance. The scale is used alongside the Mauna Model metaphor to support self-reflection and professional growth
Measured: From enrollment to the end of program at 41 weeks
Work Environment Impact Scale - Self Report (WEIS-SR)
The Work Environment Impact Scale - Self Report (WEIS-SR) will be used to assess participants' perceptions of how their academic environment influences their ability to perform and manage their responsibilities. The WEIS-SR is based on the Model of Human Occupation (MOHO) and assesses environmental factors such as social support, communication, physical environment, and work demands. This instrument helps identify environmental supports and barriers that may contribute to student stress and burnout.
Measured: From enrollment to the end of program at 41 weeks
Secondary outcomes (1)
User Experience Questionnaire - Short Version (UEQ-S)
The User Experience Questionnaire - Short Version (UEQ-S) will be administered at the end of the intervention to evaluate participants' perceptions of the usability and overall experience of the Mauna Model resiliency program. The UEQ-S measures users' perceptions of the program's efficiency and provides insight into participants' satisfaction with the intervention
Measured: End of program at 41 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This research will use a convergent parallel mixed-methods pilot design to assess both feasibility and participant outcomes. Approximately 30 first-year students enrolled in the hybrid Doctor of Occupational Therapy program at Nova Southeastern University will be invited to participate. The resiliency program will be integrated into the curriculum and delivered throughout the first year of study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848230
- Sponsor's protocol ID
- 2026-187-NSU
- Other IDs
- FY27 PRG #64
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD involves student information which is protected under FERPA. Data that will be shared in publication or conference presentations will be limited to intervention protocol, statistical analysis, and de-identified quotes to support qualitative analysis.
Publications
Shellooe, M., Madriaga, J., Pérez, V. A., & Velazquez, G. (2024). Resilience programming for occupational therapy students: A mixed-methods exploration. https://doi.org/10.33015/dominican.edu/2025.ot.04
Rubio, K., Bowyer, P., Goffredo, C., & Russell Bliss, J. (2023). Burnout among occupational therapy practitioners from diverse backgrounds: A scoping review protocol. Figshare. https://doi.org/10.6084/m9.figshare.24837330.v1
Nair, S., Behere, N., & Ghosh-Jerath, S. (2023). Burnout and depression among college students pursuing Bachelor of Physiotherapy and Occupational Therapy, in Delhi NCR - a cross-sectional study. International Journal of Occupational and Environment Safety. https://doi.org/10.24840/2184-0954_007-002_002197
Laposha, I., & Smallfield, S. (2022). Self-care: An occupational therapy student perspective. Journal of Occupational Therapy Education, 6(1). https://doi.org/10.26681/jote.2022.060105
Krpalek, D. (2025). Resiliency programming in OT curriculum: Implications for students, faculty, and clinicians. American Journal of Occupational Therapy, 30(1), 16-19.
Hammond, O., Talero Cabrejo, P., & Cruz, L. (2024). Life balance, stress, & occupational burnout in OTA students: An exploratory study. American Journal of Occupational Therapy, 78(Suppl. 2), 7811500229p1. https://doi.org/10.5014/ajot.2024.78s2-po229
D'Amico, M., Behel, S., Buono, T., Garrett, A., Tucci, A., & Swain, E. (2023). The relationship between coping, burnout, and resilience for allied health professions graduate students. Tenth Annual Research Colloquium. https://nsuworks.nova.edu/ot_colloquium/Tenth/events/4
Ausec, J. D. (2025). The Mauna model: A trail guide for developing competencies in occupational therapy professionals. Post-Professional Occupational Therapy Doctorate - Innovations in OT Symposium: Transforming Possibilities into Practice (p. 21). https://medica-musc.researchcommons.org/muscotd-ppotd/21
Shin J, McCarthy M, Schmidt C, Zellner J, Ellerman K, Britton M. Prevalence and Predictors of Burnout Among Occupational Therapy Practitioners in the United States. Am J Occup Ther. 2022 Jul 1;76(4):7604205080. doi: 10.5014/ajot.2022.048108.
PubMed 35709003Popova ES, J Hahn B, Morris H, Loomis K, Shy E, Andrews J, Iacullo M, Peters A. Exploring Well-Being: Resilience, Stress, and Self-Care in Occupational Therapy Practitioners and Students. OTJR (Thorofare N J). 2023 Apr;43(2):159-169. doi: 10.1177/15394492221091271. Epub 2022 Apr 28.
PubMed 35481402Morales-Rodriguez FM, Perez-Marmol JM, Brown T. Education Burnout and Engagement in Occupational Therapy Undergraduate Students and Its Associated Factors. Front Psychol. 2019 Dec 20;10:2889. doi: 10.3389/fpsyg.2019.02889. eCollection 2019.
PubMed 31920897
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Burnout to Balance: Implementing a Theory-Driven Resiliency Program in Occupational Therapy Doctoral Education
- ClinicalTrials.gov ID
- NCT07848230
- Acronym / sponsor ID
- 2026-187-NSU
- Conditions
- Burnout, Burnout Syndrome, Burnout Among Occupational Therapists, Burnout, Student, Burnout，Motivation，Stress，Mental Toughness
- Keywords
- Burnout, Burnout Syndrome, Burnout, Student, Occupational Therapy, Hybrid Learning, Doctoral Education, Resilience, Healthcare Student Resilience
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about burnout among first-year Occupational Therapy Doctoral (OTD) students and how it may affect their mental health, daily activities, and overall well-being. Students will be asked questions about their stress levels, daily habits, and experiences in school. The study will also evaluate a resilience program that is built into a hybrid OTD curriculum to see whether it helps students manage stress, improve their well-being, perform well academically, and support their long-term success. Researchers will look for patterns in the responses to better understand student experiences. The findings may help occupational therapy programs and other healthcare schools provide better support for students.
Detailed description
Burnout among occupational therapy (OT) students is a growing concern and has been reported at rates approaching 80%, exceeding those observed in the general student population. Contributing factors include demanding academic coursework, fieldwork preparation, financial pressures, role transitions, and limited access to effective coping resources. Burnout during professional education has been associated with decreased academic performance, poorer mental health outcomes, reduced engagement, and long-term professional strain. Despite these concerns, structured and evidence-based wellness interventions are not routinely integrated into occupational therapy curricula.
This pilot study aims to evaluate the feasibility and preliminary effectiveness of a curriculum-integrated resiliency program based on the Mauna Model for entry-level Doctor of Occupational Therapy (OTD) students enrolled in a hybrid educational program. The Mauna Model emphasizes achieving balance among personal, professional, and environmental factors to support well-being and resilience. The intervention is further informed by the Model of Human Occupation (MOHO), which recognizes the interaction between personal capacities, habits, values, and environmental influences in shaping occupational participation and health.
The study responds to emerging evidence indicating that occupational therapy students often rely on inadequate coping strategies and may benefit from intentional, evidence-based approaches to developing resilience and self-management skills. By introducing resiliency-building activities early in the educational experience, the program seeks to support students' well-being, reduce burnout risk, and promote academic and professional success.
The primary objective is to determine the feasibility, acceptability, and preliminary effectiveness of integrating a Mauna Model-based resiliency program into a hybrid OTD curriculum. Feasibility outcomes will include recruitment, retention, participation rates, and participant satisfaction. Secondary outcomes include changes in burnout, resilience, and perceived well-being. Findings from this pilot study will provide foundational data for larger-scale investigations and may inform the development of sustainable wellness initiatives within occupational therapy education programs. The long-term goal is to support student well-being, academic success, professional readiness, and workforce sustainability by reducing burnout and strengthening resilience among future occupational therapy practitioners
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This research will use a convergent parallel mixed-methods pilot design to assess both feasibility and participant outcomes. Approximately 30 first-year students enrolled in the hybrid Doctor of Occupational Therapy program at Nova Southeastern University will be invited to participate. The resiliency program will be integrated into the curriculum and delivered throughout the first year of study.
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Behavioral: Mauna Model Resiliency ProgramThe study only involves one group of student participants and will participate in the Mauna Model Resiliency Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled as a first-year student in the Doctor of Occupational Therapy (OTD) program at Nova Southeastern University Tampa Bay Regional Campus (NSU-TBRC)
- 18 years of age or older
- Able to read and understand English, as all materials will be administered in English
- Willing to provide informed consent and participate in study procedures including surveys, reflection activities, and optional focus groups
Key exclusion criteria (1 listed)
- Not enrolled in the NSU-TBRC OTD program as a first year student
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 |
|---|---|---|
| Mauna Model Resiliency Program"Mauna" is a term for mountain. The program uses a mountain hike metaphor to represent the career journey, it emphasizes self-reflection, competency development, and mentorship to build confidence and resilience during transitions such as the shift from student to practitioner. Unlike client-focused models, the Mauna Model supports professional growth by helping OT students and practitioners identify, develop, and reflect on core competencies | Behavioural | Single Group |
Primary outcome
Maslach Burnout Inventory-Student Survey (MBI-SS)
Time frame: From enrollment to the end of program at 41 weeks
The Maslach Burnout Inventory-Student Survey (MBI-SS) will be used to measure academic burnout among participants. The MBI-SS assesses three key components of burnout: emotional exhaustion, cynicism or depersonalization, and reduced personal accomplishment. Participants rate the frequency of burnout-related experiences on a Likert scale. This instrument is widely used in research involving students and healthcare professionals and has demonstrated strong validity and reliability
Mauna Model Compass
Time frame: From enrollment to the end of program at 41 weeks
The Mauna Model Self-Rating Scale Compass will be used to assess participants' perceived competencies related to professional development and resilience. This scale allows participants to reflect on areas such as interpersonal skills, intrapersonal development, technical competence, ethical practice, and occupational balance. The scale is used alongside the Mauna Model metaphor to support self-reflection and professional growth
Work Environment Impact Scale - Self Report (WEIS-SR)
Time frame: From enrollment to the end of program at 41 weeks
The Work Environment Impact Scale - Self Report (WEIS-SR) will be used to assess participants' perceptions of how their academic environment influences their ability to perform and manage their responsibilities. The WEIS-SR is based on the Model of Human Occupation (MOHO) and assesses environmental factors such as social support, communication, physical environment, and work demands. This instrument helps identify environmental supports and barriers that may contribute to student stress and burnout.
1 secondary outcome
User Experience Questionnaire - Short Version (UEQ-S)
Time frame: End of program at 41 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- BackgroundShellooe, M., Madriaga, J., Pérez, V. A., & Velazquez, G. (2024). Resilience programming for occupational therapy students: A mixed-methods exploration. https://doi.org/10.33015/dominican.edu/2025.ot.04
- BackgroundRubio, K., Bowyer, P., Goffredo, C., & Russell Bliss, J. (2023). Burnout among occupational therapy practitioners from diverse backgrounds: A scoping review protocol. Figshare. https://doi.org/10.6084/m9.figshare.24837330.v1
- BackgroundNair, S., Behere, N., & Ghosh-Jerath, S. (2023). Burnout and depression among college students pursuing Bachelor of Physiotherapy and Occupational Therapy, in Delhi NCR - a cross-sectional study. International Journal of Occupational and Environment Safety. https://doi.org/10.24840/2184-0954_007-002_002197
- BackgroundLaposha, I., & Smallfield, S. (2022). Self-care: An occupational therapy student perspective. Journal of Occupational Therapy Education, 6(1). https://doi.org/10.26681/jote.2022.060105
- BackgroundKrpalek, D. (2025). Resiliency programming in OT curriculum: Implications for students, faculty, and clinicians. American Journal of Occupational Therapy, 30(1), 16-19.
- BackgroundHammond, O., Talero Cabrejo, P., & Cruz, L. (2024). Life balance, stress, & occupational burnout in OTA students: An exploratory study. American Journal of Occupational Therapy, 78(Suppl. 2), 7811500229p1. https://doi.org/10.5014/ajot.2024.78s2-po229
- BackgroundD'Amico, M., Behel, S., Buono, T., Garrett, A., Tucci, A., & Swain, E. (2023). The relationship between coping, burnout, and resilience for allied health professions graduate students. Tenth Annual Research Colloquium. https://nsuworks.nova.edu/ot_colloquium/Tenth/events/4
- BackgroundAusec, J. D. (2025). The Mauna model: A trail guide for developing competencies in occupational therapy professionals. Post-Professional Occupational Therapy Doctorate - Innovations in OT Symposium: Transforming Possibilities into Practice (p. 21). https://medica-musc.researchcommons.org/muscotd-ppotd/21
- Background: PubMed 35709003Shin J, McCarthy M, Schmidt C, Zellner J, Ellerman K, Britton M. Prevalence and Predictors of Burnout Among Occupational Therapy Practitioners in the United States. Am J Occup Ther. 2022 Jul 1;76(4):7604205080. doi: 10.5014/ajot.2022.048108.
- Background: PubMed 35481402Popova ES, J Hahn B, Morris H, Loomis K, Shy E, Andrews J, Iacullo M, Peters A. Exploring Well-Being: Resilience, Stress, and Self-Care in Occupational Therapy Practitioners and Students. OTJR (Thorofare N J). 2023 Apr;43(2):159-169. doi: 10.1177/15394492221091271. Epub 2022 Apr 28.
- Background: PubMed 31920897Morales-Rodriguez FM, Perez-Marmol JM, Brown T. Education Burnout and Engagement in Occupational Therapy Undergraduate Students and Its Associated Factors. Front Psychol. 2019 Dec 20;10:2889. doi: 10.3389/fpsyg.2019.02889. eCollection 2019.
- Individual participant dataSharing planned: No. IPD involves student information which is protected under FERPA. Data that will be shared in publication or conference presentations will be limited to intervention protocol, statistical analysis, and de-identified quotes to support qualitative analysis.
Related trials for Burnout
Recruiting
Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
Psychiatric Disorder
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Recruiting
THE EFFECT OF EDUCATION IN PATIENTS WITH HYPERTENSION
Hypertension
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Enrolling by invitation
Physical and Psychosocial Outcomes of 16-Week Classroom-Based Morning Exercise Program
Healthy Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mauna Model Resiliency Program in people with Burnout and Burnout Syndrome, run by Nova Southeastern University 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 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach Burnout Inventory-Student Survey (MBI-SS) (time frame: From enrollment to the end of program at 41 weeks). 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 NCT07848230, which also lists 11 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 29 Sep 2026.