Burnout, ProfessionalNCT05635448
Better Together Physician Coaching to Mitigate Burnout Amongst Clinicians
A study testing Better Together Physician Coaching Program in people with Burnout, Professional and Self Compassion, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Better Together Physician Coaching ("Better Together", or "BT"), a 4-month, web-based positive psychology multimodal coaching program was built to decrease burnout in medical trainees. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Self Compassion, Flourishing
- What is being tested?
- Better Together Physician Coaching Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Colorado School of Medicine (CU SOM) clinicians AND
- Faculty
Who cannot join
- Non-CU SOM clinicians, non-faculty
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80230
About this study
Official title: Better Together Physician Coaching: Addressing Burnout Amongst Clinicians
Better Together Physician Coaching ("Better Together", or "BT"), a 4-month, web-based positive psychology multimodal coaching program was built to decrease burnout in medical trainees. Here, the investigators seek to understand it's efficacy in University of Colorado School of Medicine (CU SOM) clinicians
Aim 1: Implement Better Together in University of Colorado School of Medicine clinicians Aim 2: Assess outcomes: primary: reduce burnout as measured by the Maslach Burnout Index (goal: 10% relative improvement), and secondary: self-compassion, imposter syndrome, flourishing, loneliness, and moral injury.
Aim 3: Advance the field of coaching for clinicians through innovation and dissemination of evidence-based approaches to clinician wellbeing.
Read the detailed description
Burnout refers to feelings of exhaustion, negativism, and reduced personal efficacy resulting from chronic workplace stress. In healthcare, burnout leads to increased medical errors, poorer patient care and negatively affects professional development and retention. Burnout is a growing problem that begins early in medical training. Professional coaching is a metacognition tool with a sustainable positive effect on physician well-being but typically relies on expensive consultants or time-consuming faculty development, often making it infeasible for medical training programs to offer. To overcome this barrier, the investigators created Better Together Physician Coaching (BT) a 4-month coaching program for at the University of Colorado (CU). BT includes regular online group-coaching, written coaching, and weekly self-study modules delivered by physician life coaches (Co-PIs). In 2021, the investigators studied BT in a group of female-identifying resident trainees at CU and found that the program significantly improved burnout, imposter syndrome, and self-compassion. This finding supports previous data that life coaching is effective for physicians and physicians in training. The investigators initially focused on women since burnout affects women to a greater degree than their male counterparts, and may have long-lasting consequences on their careers, contributing to a "leaky pipeline" effect. The pilot randomized controlled trial (RCT) of 101 BT women participants demonstrated a statistically significant improvement in burnout, self-compassion, and imposter syndrome in the intervention group.
The investigators now seek to understand if the coaching program is also effective in clinicians of all gender identities.
The hypothesis is that Better Together Physician Coaching ("Better Together", or "BT"), a 4-month, web-based positive psychology multimodal coaching program will result in decreased burnout in University of Colorado School of Medicine (CU SOM) clinicians.
Aim 1: Implement Better Together in CU SOM clinicians Aim 2: Assess outcomes: primary: reduce burnout as measured by the Maslach Burnout Index (goal: 10% relative improvement), and secondary: self-compassion, imposter syndrome, flourishing, loneliness, and moral injury.
Aim 3: Advance the field of coaching for clinicians through innovation and dissemination of evidence-based approaches to clinician wellbeing.
- Conditions
- Burnout, Professional, Self Compassion, Flourishing, Imposter Syndrome, Moral Injury, Loneliness
- Being tested
- Better Together Physician Coaching Program, No intervention - waitlist control
- Medical subject headings
- Burnout, Professional, imposter syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better Together Physician Coaching ProgramBehavioural
thought-based coaching. This type of coaching focuses on thoughts and beliefs. It combines a cognitive behavioral therapy (CBT) model with mindfulness-based awareness and integrates theories of acceptance and commitment therapy (ACT), nonattachment, and radical questioning from Socratic and Greek philosophies. BT delivers a robust coaching experience via a 4-month web-based, group-coaching model. This novel program allows residents to participate as actively as they are inclined and able, offering flexibility via multiple modalities of coaching: twice weekly group coaching calls, unlimited anonymous written coaching, and weekly self-study modules that are housed on a secure members-only website.
No intervention - waitlist controlBehavioural
No intervention - waitlist control
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will be offered the BT coaching intervention over 4-months (February 1st 2023- May 31st 2023). Receives: Behavioral: Better Together Physician Coaching Program |
| Waitlist control | Placebo comparator | Will be offered the coaching intervention following 4-month waitlist control (September 1st 2023 - December 31st 2023). Receives: Behavioral: No intervention - waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout as defined by the Maslach Burnout Inventory (MBI): Change from pre to post test
The Maslach burnout inventory (MBI) is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores of EE ≥ 27 points, DP ≥ 10, and PF <33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention.
Secondary outcomes (5)
Self-Compassion as defined by Neff's Self Compassion Score Short Form (SCS-SF): Change from pre to post test
Neff's Self Compassion Score Short Form (SCS-SF) is a 12-item measurement of self-compassion. Possible scores range from 0-6 on a Likert scale for each item, where the higher scale scores indicate greater self-compassion. Scores of 1.0- 2.49 are considered to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Moral Injury as defined by the Moral Injury Symptom Scale for Health Professions (MISS-HP): Change from pre to post test
Moral Injury Symptom Scale for Health Professions (MISS-HP) is a 10-item measurement of moral injury. Possible scores range from 0-5 on a Likert scale for each item, where the higher scale scores indicate greater moral injury. Scores >35(on a possible score range of 10 to 100) are considered high for moral injury symptoms causing moderate to extreme problems with family, social, and occupational functioning.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Imposter Syndrome as defined by Young's Imposter Syndrome Symptoms Scale (YISS): Change from pre to post test
Young's Imposter Syndrome Symptoms Scale (YISS) is a 8-item measurement of imposter syndrome. Scoring is yes/no where a score of >5/8 is felt to be positive for imposter syndrome.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Flourishing as defined by the Secure Flourish Index (SFI): Change from pre to post test
The Secure Flourish Index (SFI) is a 12 item measurement of flourishing at work and includes the domains of (D1) happiness and life satisfaction; (D2) physical and mental health; (D3) meaning and purpose; (D4) character and virtue; and (D5) close social relationships plus 2 questions on having adequate stability as well as material and financial resources so that flourishing is likely to continue. Scores range from a low of 0 to a high of 120, though the secure flourishing scores are often reported as averages of the questions (rather than sums) so that all scores are on a scale of 0-10.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Loneliness as defined by the UCLA 3-item Loneliness Scale: Change from pre to post test
The UCLA 3-item Loneliness Scale measures feelings of loneliness. It is a shortened version of the 20-item Revised UCLA Loneliness Scale. Possible scores range from 1-3 on a Likert scale for each item with 1 = Hardly ever; 2 = Some of the time; 3 = Often. The three items are summed to give a total score between 3 to 9 with higher scores indicating a higher degree of loneliness.
Measured: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start2 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized controlled trial. All enrolled participants will complete the pretest baseline survey. After baseline data collection is completed, the participants will be randomized into either a control or intervention group. This randomized controlled trial study design will offer the BT coaching to the intervention group for the duration of 4-months (February 1st 2023- May 31st 2023) and to the control group for the duration of 4-months (September 1st 2023 - December 31st 2023). At two different timepoints, all participants will be offered surveys containing the following validated indices: burnout, imposter syndrome, self-compassion, moral injury, discrimination, and flourishing. All participants will be offered the survey at baseline- January 2023 (T0), post intervention- May 2023 (T1).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635448
- Sponsor's protocol ID
- 22-2158
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villwock JA, Sobin LB, Koester LA, Harris TM. Impostor syndrome and burnout among American medical students: a pilot study. Int J Med Educ. 2016 Oct 31;7:364-369. doi: 10.5116/ijme.5801.eac4.
PubMed 27802178Mantri S, Lawson JM, Wang Z, Koenig HG. Identifying Moral Injury in Healthcare Professionals: The Moral Injury Symptom Scale-HP. J Relig Health. 2020 Oct;59(5):2323-2340. doi: 10.1007/s10943-020-01065-w.
PubMed 32681398Kelly-Hedrick M, Rodriguez MM, Ruble AE, Wright SM, Chisolm MS. Measuring Flourishing Among Internal Medicine and Psychiatry Residents. J Grad Med Educ. 2020 Jun;12(3):312-319. doi: 10.4300/JGME-D-19-00793.1.
PubMed 32595851Fainstad T, Mann A, Suresh K, Shah P, Dieujuste N, Thurmon K, Jones CD. Effect of a Novel Online Group-Coaching Program to Reduce Burnout in Female Resident Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210752. doi: 10.1001/jamanetworkopen.2022.10752.
PubMed 35522281Maslach, C., Jackson, S. E., & Leiter, M. P. (1997). Maslach Burnout Inventory: Third edition. In C. P. Zalaquett & R. J. Wood (Eds.), Evaluating stress: A book of resources (pp. 191-218). Scarecrow Education.
Neff KD. Self-Compassion Scale. PsycTESTS Dataset. 2012. doi:10.1037/t10178-000
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506Fainstad T, Rodriguez C, Kreisel C, Caragol J, Thibodeau PS, Kostiuk M, Mann A. Impact of an Online Group-Coaching Program on Ambulatory Faculty Physician Well-Being: A Randomized Trial. J Am Board Fam Med. 2025 Mar 21;37(6):1055-1071. doi: 10.3122/jabfm.2024.240022R1.
PubMed 39725465
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Together Physician Coaching: Addressing Burnout Amongst Clinicians
- ClinicalTrials.gov ID
- NCT05635448
- Acronym / sponsor ID
- 22-2158
- Conditions
- Burnout, Professional, Self Compassion, Flourishing, Imposter Syndrome, Moral Injury, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 2 Dec 2022 (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.
Better Together Physician Coaching ("Better Together", or "BT"), a 4-month, web-based positive psychology multimodal coaching program was built to decrease burnout in medical trainees. Here, the investigators seek to understand it's efficacy in University of Colorado School of Medicine (CU SOM) clinicians
Aim 1: Implement Better Together in University of Colorado School of Medicine clinicians Aim 2: Assess outcomes: primary: reduce burnout as measured by the Maslach Burnout Index (goal: 10% relative improvement), and secondary: self-compassion, imposter syndrome, flourishing, loneliness, and moral injury.
Aim 3: Advance the field of coaching for clinicians through innovation and dissemination of evidence-based approaches to clinician wellbeing.
Detailed description
Burnout refers to feelings of exhaustion, negativism, and reduced personal efficacy resulting from chronic workplace stress. In healthcare, burnout leads to increased medical errors, poorer patient care and negatively affects professional development and retention. Burnout is a growing problem that begins early in medical training. Professional coaching is a metacognition tool with a sustainable positive effect on physician well-being but typically relies on expensive consultants or time-consuming faculty development, often making it infeasible for medical training programs to offer. To overcome this barrier, the investigators created Better Together Physician Coaching (BT) a 4-month coaching program for at the University of Colorado (CU). BT includes regular online group-coaching, written coaching, and weekly self-study modules delivered by physician life coaches (Co-PIs). In 2021, the investigators studied BT in a group of female-identifying resident trainees at CU and found that the program significantly improved burnout, imposter syndrome, and self-compassion. This finding supports previous data that life coaching is effective for physicians and physicians in training. The investigators initially focused on women since burnout affects women to a greater degree than their male counterparts, and may have long-lasting consequences on their careers, contributing to a "leaky pipeline" effect. The pilot randomized controlled trial (RCT) of 101 BT women participants demonstrated a statistically significant improvement in burnout, self-compassion, and imposter syndrome in the intervention group.
The investigators now seek to understand if the coaching program is also effective in clinicians of all gender identities.
The hypothesis is that Better Together Physician Coaching ("Better Together", or "BT"), a 4-month, web-based positive psychology multimodal coaching program will result in decreased burnout in University of Colorado School of Medicine (CU SOM) clinicians.
Aim 1: Implement Better Together in CU SOM clinicians Aim 2: Assess outcomes: primary: reduce burnout as measured by the Maslach Burnout Index (goal: 10% relative improvement), and secondary: self-compassion, imposter syndrome, flourishing, loneliness, and moral injury.
Aim 3: Advance the field of coaching for clinicians through innovation and dissemination of evidence-based approaches to clinician wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial. All enrolled participants will complete the pretest baseline survey. After baseline data collection is completed, the participants will be randomized into either a control or intervention group. This randomized controlled trial study design will offer the BT coaching to the intervention group for the duration of 4-months (February 1st 2023- May 31st 2023) and to the control group for the duration of 4-months (September 1st 2023 - December 31st 2023). At two different timepoints, all participants will be offered surveys containing the following validated indices: burnout, imposter syndrome, self-compassion, moral injury, discrimination, and flourishing. All participants will be offered the survey at baseline- January 2023 (T0), post intervention- May 2023 (T1).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Better Together Physician Coaching ProgramWill be offered the BT coaching intervention over 4-months (February 1st 2023- May 31st 2023). |
| Waitlist control | Placebo comparator | Behavioral: No intervention - waitlist controlWill be offered the coaching intervention following 4-month waitlist control (September 1st 2023 - December 31st 2023). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- University of Colorado School of Medicine (CU SOM) clinicians AND
- Faculty
Key exclusion criteria (1 listed)
- Non-CU SOM clinicians, non-faculty
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 |
|---|---|---|
| Better Together Physician Coaching Programthought-based coaching. This type of coaching focuses on thoughts and beliefs. It combines a cognitive behavioral therapy (CBT) model with mindfulness-based awareness and integrates theories of acceptance and commitment therapy (ACT), nonattachment, and radical questioning from Socratic and Greek philosophies. BT delivers a robust coaching experience via a 4-month web-based, group-coaching model. This novel program allows residents to participate as actively as they are inclined and able, offering flexibility via multiple modalities of coaching: twice weekly group coaching calls, unlimited anonymous written coaching, and weekly self-study modules that are housed on a secure members-only website. | Behavioural | Intervention |
| No intervention - waitlist controlNo intervention - waitlist control | Behavioural | Waitlist control |
Primary outcome
Burnout as defined by the Maslach Burnout Inventory (MBI): Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention.
The Maslach burnout inventory (MBI) is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores of EE ≥ 27 points, DP ≥ 10, and PF <33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.
5 secondary outcomes
Self-Compassion as defined by Neff's Self Compassion Score Short Form (SCS-SF): Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Moral Injury as defined by the Moral Injury Symptom Scale for Health Professions (MISS-HP): Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Imposter Syndrome as defined by Young's Imposter Syndrome Symptoms Scale (YISS): Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Flourishing as defined by the Secure Flourish Index (SFI): Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention
Loneliness as defined by the UCLA 3-item Loneliness Scale: Change from pre to post test
Time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month 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 4 Oct 2024.
- Background: PubMed 27802178Villwock JA, Sobin LB, Koester LA, Harris TM. Impostor syndrome and burnout among American medical students: a pilot study. Int J Med Educ. 2016 Oct 31;7:364-369. doi: 10.5116/ijme.5801.eac4.
- Background: PubMed 32681398Mantri S, Lawson JM, Wang Z, Koenig HG. Identifying Moral Injury in Healthcare Professionals: The Moral Injury Symptom Scale-HP. J Relig Health. 2020 Oct;59(5):2323-2340. doi: 10.1007/s10943-020-01065-w.
- Background: PubMed 32595851Kelly-Hedrick M, Rodriguez MM, Ruble AE, Wright SM, Chisolm MS. Measuring Flourishing Among Internal Medicine and Psychiatry Residents. J Grad Med Educ. 2020 Jun;12(3):312-319. doi: 10.4300/JGME-D-19-00793.1.
- Background: PubMed 35522281Fainstad T, Mann A, Suresh K, Shah P, Dieujuste N, Thurmon K, Jones CD. Effect of a Novel Online Group-Coaching Program to Reduce Burnout in Female Resident Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210752. doi: 10.1001/jamanetworkopen.2022.10752.
- BackgroundMaslach, C., Jackson, S. E., & Leiter, M. P. (1997). Maslach Burnout Inventory: Third edition. In C. P. Zalaquett & R. J. Wood (Eds.), Evaluating stress: A book of resources (pp. 191-218). Scarecrow Education.
- BackgroundNeff KD. Self-Compassion Scale. PsycTESTS Dataset. 2012. doi:10.1037/t10178-000
- Background: PubMed 18504506Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Derived from this study: PubMed 39725465Fainstad T, Rodriguez C, Kreisel C, Caragol J, Thibodeau PS, Kostiuk M, Mann A. Impact of an Online Group-Coaching Program on Ambulatory Faculty Physician Well-Being: A Randomized Trial. J Am Board Fam Med. 2025 Mar 21;37(6):1055-1071. doi: 10.3122/jabfm.2024.240022R1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better Together Physician Coaching Program in people with Burnout, Professional and Self Compassion, run by University of Colorado, Denver 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 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Burnout as defined by the Maslach Burnout Inventory (MBI): Change from pre to post test (time frame: pretest will occur prior to the intervention and posttest will occur after the 4-month intervention.). 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 NCT05635448, which also lists 8 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 4 Oct 2024.