DepressionNCT06620783
The Efficacy of an Exercise Program and a Yoga Program in Mitigating Stress and Improving Mental Health Among Employees
A study testing exercise, yoga and active self-care in people with Depression and PTSD, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
To reduce workplace stress and promote mental health, participants were divided into three groups: exercise program, yoga program, and self-care. The effectiveness of the exercise and yoga programs was evaluated using pre- and post-program self-reported questionnaires, HRV (Heart Rate Variability), and 2-lead EEG. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, PTSD, Work Related Stress
- What is being tested?
- exercise, yoga and active self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 Oct 2023to 31 Mar 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Employed individuals aged 19 to 49 years.
- Participants with moderate stress levels, scoring 14 or higher on the Perceived Stress Scale.
- Individuals currently undergoing pharmacological treatment for psychiatric conditions such as depression, anxiety disorders, or insomnia, provided they are in a stable phase with no expected changes in medication dosage during the clinical trial period.
- Participants who fully understand the clinical trial protocol and have voluntarily consented to participate.
Who cannot join
- Adults under the age of 19 or over the age of 49.
- Individuals with dementia, intellectual disabilities, or other cognitive impairments.
- Those with neurological disorders such as epileptic conditions, stroke, or other neurological diseases.
- Individuals with a history of, or currently diagnosed with, psychiatric disorders like schizophrenia or bipolar disorder.
- Individuals with a history of suicidal ideation or attempts.
- Those taking medications or having conditions determined by the research team to potentially affect the reliability of the HRV (Heart Rate Variability) test (e.g., heart disease, pulmonary disease, etc.).
- Those who have received non-pharmacological psychiatric treatment or counseling in the current or past 6 months.
- Individuals deemed by the research team to have physical limitations that make it difficult to participate in exercise or yoga programs.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13605
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul
About this study
To reduce workplace stress and promote mental health, participants were divided into three groups: exercise program, yoga program, and self-care. The effectiveness of the exercise and yoga programs was evaluated using pre- and post-program self-reported questionnaires, HRV (Heart Rate Variability), and 2-lead EEG.
Read the detailed description
After screening, a preliminary assessment is conducted on the study participants who have agreed to participate. The preliminary assessment includes medical history review, questionnaires related to current physical activity levels, mental health-related questionnaires concerning stress, depression, insomnia, job stress, and job burnout. It also includes tests for heart rate variability (HRV), physiological stress-related indicators via a 2-lead EEG, and a basic physical ability assessment. After the preliminary evaluation:
Those in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
The yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
The self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks.
After completing their respective programs, participants from the exercise group, yoga group, and the self-care control group will revisit the hospital within a week to undergo the same tests as in the preliminary evaluation, excluding medical history and physical activity information. Moreover, to determine whether the effects of the exercise and yoga programs persist after the program ends, participants will return for the same tests one month after the 4-week program concludes. Using the data obtained, the study will measure the changes induced by the self-directed exercise and yoga programs on the participants' clinical scales like stress, symptoms of depression, HRV, EEG, and basic physical abilities. The effects on the improvement of psychological and physiological stress indicators of the self-care group, using stress data, will then be compared and analyzed.
- Conditions
- Depression, PTSD, Work Related Stress
- Being tested
- exercise, yoga, active self-care
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Those in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
yogaBehavioural
The yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
active self-careBehavioural
The self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| exercise program group | Active comparator | Those in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. Receives: Behavioral: exercise |
| yoga program group | Active comparator | The yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. Receives: Behavioral: yoga |
| self-care group | Sham comparator | The self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks. Receives: Behavioral: active self-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level
Stress level by the Perceived Stress Scale. We will use the Korean version of the Perceived Stress Scale, originally developed by Cohen et al. (1983) and revised by Cohen et al. in 1988. This version has been adapted into Korean and validated to measure participants\' perceived stress experiences. The total score ranges from 0 to 40, with each item rated on a 5-point Likert scale from 0 (never) to 4 (very often). A higher score indicates a greater perception of unpredictability, lack of control, and overwhelming stress-related experiences over the past month.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Depression level
Depression level by the Patient Health Questionnaire 9. This is a self-report assessment tool designed to briefly screen for depressive disorders and evaluate the severity of depressive symptoms (Kroenke et al., 2001). It comprises items corresponding to the nine diagnostic criteria for major depressive disorder according to the DSM-IV, based on depressive symptoms experienced over the past two weeks. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores of 5 or above, 10 or above, 15 or above, and 20 or above suggest mild, moderate, moderately severe, and severe depression, respectively.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Secondary outcomes (8)
Insomnia level
Insomnia level by the Insomnia severity index. This self-report scale, developed by Morin (1993), assesses the severity of insomnia based on the diagnostic criteria of the DSM-IV and the International Classification of Sleep Disorders (ICSD). It consists of seven items evaluating the type and severity of insomnia over the past two weeks, including sleep satisfaction, daytime functioning impairment, sleep-related difficulties, and distress caused by sleep problems. The total score ranges from 0 to 28, with scores of 8 to 14 indicating mild insomnia, 15 to 21 indicating moderate clinical insomnia, and 22 or above indicating severe insomnia.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
PTSD symptoms
To measure the level of PTSD symptoms in study participants, we will use the PTSD Checklist for DSM-5 (PCL-5), developed by Weathers et al. (2013), based on the diagnostic criteria of the DSM-5. The PCL-5 is an adaptation of the PTSD Checklist (PCL), originally created by Weathers et al. (1993), and was translated by Park et al. (2016) and validated by Lee et al. (2020). The PCL-5 assesses the severity of symptoms experienced over the past month due to a past traumatic event. It consists of 20 items rated on a 5-point Likert scale (0 = Not at all, 4 = Extremely), with higher scores indicating more severe PTSD symptoms. The PCL-5 includes subscales for intrusion, avoidance, negative alterations in cognition and mood, and hyperarousal. The provisional cutoff score is known to be between 31 and 33, with a cutoff of 25.5 identified in a validation study of the general Korean adult population (Lee et al., 2022; Bovin et al., 2016).
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Work-related stress levels
This tool is the shortened version of the Korean Occupational Stress Scale (KOSS), originally consisting of 43 items, now reduced to 24 items. Each item is rated on a 5-point Likert scale ranging from 1 (Not at all) to 5 (Very much). Higher scores indicate higher levels of job stress experienced over the past month. The scale covers seven domains: job demands, job autonomy, job insecurity, interpersonal conflict, organizational system, inadequate compensation, and workplace culture. It was designed for easy application in field settings (Jang Se-jin et al., 2005).
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Burnout symptoms
To measure the current level of job burnout in the study participants, we will use the Maslach Burnout Inventory-General Survey (MBI-GS), developed by Schaufeli et al. (1996) to assess burnout in general workers, and adapted and validated by Shin Kang-hyun (2003). This scale evaluates the three core dimensions of burnout syndrome experienced in the workplace: exhaustion, cynicism, and professional efficacy. Each dimension consists of five items, rated on a 7-point Likert scale from 0 (strongly disagree) to 6 (strongly agree). Higher scores in the exhaustion and cynicism dimensions, and lower scores in the professional efficacy dimension, indicate greater levels of job burnout.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Emotional states
To measure participants\' positive and negative affect, we will use the revised Korean version of the Positive and Negative Affect Schedule (K-PANAS-R). This scale was originally developed by Watson et al. (1988) and was validated in Korean by Lee Hyun-hee et al. (2003). Park Hong-seok et al. (2016) reviewed its limitations and revised the scale through translation and back-translation of the original. The K-PANAS-R assesses emotions experienced by participants over the past week using 20 items, each rated on a 5-point Likert scale, reflecting the intensity of the emotions described by the adjectives.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Basic physical level
To assess baseline physical fitness levels, the following tests, as recommended by the Korean Society of Sports Science, were conducted and the respective results were recorded: flexibility, muscle strength, knee push-up, gait test, and balance test.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
2-lead EEG
For measuring neural activity in the prefrontal lobe, we will use a 2-channel EEG (FP1, FP2). EEG is a non-invasive method that quantifies brain electrical activity by attaching electrodes to the scalp to capture electrical signals generated by potential differences. This method is non-invasive, offers excellent temporal resolution, and is cost-effective, making it widely applicable in studies involving general populations. The raw data collected by the device are processed using TeleScan (© Laxtha, Inc.) to calculate absolute power, frequency ratio, relative power, and symmetry across different frequency bands. The key indicators derived from the data include: Theta, Alpha, Low-Beta, Mid-Beta, High-Beta, Gamma, the (Low-Beta + Mid-Beta)/Theta power ratio, and the Alpha/High-Beta power ratio.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Heart rate variability
Heart rate variability (HRV) is an effective method for quantitatively assessing autonomic nervous system activity and balance. It is widely used to examine changes in autonomic activity and balance caused by stress, as well as to gather information on stress-related disorders. HRV can be analyzed using various methods, with time domain analysis and frequency domain analysis being the most commonly employed. In this study, we will use several frequently used indicators from frequency domain analysis in HRV research, including: TP (total power), LF (low frequency), HF (high frequency), and the LF/HF+LF ratio.
Measured: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Oct 2023
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Boramae Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620783
- Sponsor's protocol ID
- B-2309-855-301
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Yoo SY, Oh S, Moon SY, Lee K, Nam KH, Park H, Jung SH, Choi HJ, Kim HJ, Lee SI, Kim N, Song M, Min B, Lee JH, Shin JA. Effectiveness of Mobile-Delivered Exercise and Yoga Programs on Depressive Symptom Reduction in Employees: Randomized Controlled Trial. JMIR Hum Factors. 2026 Sep 1;13:e80287. doi: 10.2196/80287.
PubMed 42687778
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of an Exercise Program and a Yoga Program in Mitigating Stress and Improving Mental Health Among Employees
- ClinicalTrials.gov ID
- NCT06620783
- Acronym / sponsor ID
- B-2309-855-301
- Conditions
- Depression, PTSD, Work Related Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Boramae Hospital
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Oct 2024 (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.
To reduce workplace stress and promote mental health, participants were divided into three groups: exercise program, yoga program, and self-care. The effectiveness of the exercise and yoga programs was evaluated using pre- and post-program self-reported questionnaires, HRV (Heart Rate Variability), and 2-lead EEG.
Detailed description
After screening, a preliminary assessment is conducted on the study participants who have agreed to participate. The preliminary assessment includes medical history review, questionnaires related to current physical activity levels, mental health-related questionnaires concerning stress, depression, insomnia, job stress, and job burnout. It also includes tests for heart rate variability (HRV), physiological stress-related indicators via a 2-lead EEG, and a basic physical ability assessment. After the preliminary evaluation:
Those in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
The yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.
The self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks.
After completing their respective programs, participants from the exercise group, yoga group, and the self-care control group will revisit the hospital within a week to undergo the same tests as in the preliminary evaluation, excluding medical history and physical activity information. Moreover, to determine whether the effects of the exercise and yoga programs persist after the program ends, participants will return for the same tests one month after the 4-week program concludes. Using the data obtained, the study will measure the changes induced by the self-directed exercise and yoga programs on the participants' clinical scales like stress, symptoms of depression, HRV, EEG, and basic physical abilities. The effects on the improvement of psychological and physiological stress indicators of the self-care group, using stress data, will then be compared and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise program group | Active comparator | Behavioral: exerciseThose in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. |
| yoga program group | Active comparator | Behavioral: yogaThe yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. |
| self-care group | Sham comparator | Behavioral: active self-careThe self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Employed individuals aged 19 to 49 years.
- Participants with moderate stress levels, scoring 14 or higher on the Perceived Stress Scale.
- Individuals currently undergoing pharmacological treatment for psychiatric conditions such as depression, anxiety disorders, or insomnia, provided they are in a stable phase with no expected changes in medication dosage during the clinical trial period.
- Participants who fully understand the clinical trial protocol and have voluntarily consented to participate.
Key exclusion criteria (8 listed)
- Adults under the age of 19 or over the age of 49.
- Individuals with dementia, intellectual disabilities, or other cognitive impairments.
- Those with neurological disorders such as epileptic conditions, stroke, or other neurological diseases.
- Individuals with a history of, or currently diagnosed with, psychiatric disorders like schizophrenia or bipolar disorder.
- Individuals with a history of suicidal ideation or attempts.
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 |
|---|---|---|
| exerciseThose in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. | Behavioural | exercise program group |
| yogaThe yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks. | Behavioural | yoga program group |
| active self-careThe self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks. | Behavioural | self-care group |
Primary outcome
Stress level
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Stress level by the Perceived Stress Scale. We will use the Korean version of the Perceived Stress Scale, originally developed by Cohen et al. (1983) and revised by Cohen et al. in 1988. This version has been adapted into Korean and validated to measure participants\' perceived stress experiences. The total score ranges from 0 to 40, with each item rated on a 5-point Likert scale from 0 (never) to 4 (very often). A higher score indicates a greater perception of unpredictability, lack of control, and overwhelming stress-related experiences over the past month.
Depression level
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Depression level by the Patient Health Questionnaire 9. This is a self-report assessment tool designed to briefly screen for depressive disorders and evaluate the severity of depressive symptoms (Kroenke et al., 2001). It comprises items corresponding to the nine diagnostic criteria for major depressive disorder according to the DSM-IV, based on depressive symptoms experienced over the past two weeks. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores of 5 or above, 10 or above, 15 or above, and 20 or above suggest mild, moderate, moderately severe, and severe depression, respectively.
8 secondary outcomes
Insomnia level
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
PTSD symptoms
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Work-related stress levels
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Burnout symptoms
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Emotional states
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Basic physical level
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
2-lead EEG
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Heart rate variability
Time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
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 1 Oct 2024.
- Derived from this study: PubMed 42687778Kim JH, Yoo SY, Oh S, Moon SY, Lee K, Nam KH, Park H, Jung SH, Choi HJ, Kim HJ, Lee SI, Kim N, Song M, Min B, Lee JH, Shin JA. Effectiveness of Mobile-Delivered Exercise and Yoga Programs on Depressive Symptom Reduction in Employees: Randomized Controlled Trial. JMIR Hum Factors. 2026 Sep 1;13:e80287. doi: 10.2196/80287.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise, yoga and active self-care in people with Depression and PTSD, run by Seoul National University Hospital at 2 sites in South Korea.
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 8 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 1 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 2 sites in South Korea. 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?
Stress level (time frame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up). The study lists 2 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 NCT06620783, which also lists 1 linked publication.
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 2024.