DepressionNCT06324864
START NOW Adapted: Culturally Adapted Version of START NOW
A study testing START NOW Adapted in people with Depression and Depression/Anxiety, run by Prof. Christina Stadler at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression, Depression/Anxiety, Anxiety
- What is being tested?
- START NOW Adapted
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2024to Dec 2026
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being a migrant resettled in Switzerland temporarily or permanently
- Aged between 14 and 18
- Able to speak, read and understand one of the following languages: German, English, Turkish, Farsi, Dari, Ukrainian, Algerian Arabic or Pashto
- Able to give informed consent as documented by signature
- At least sub-clinical depressive symptoms assessed by the Hopkins Symptom Checklist-25 (HSCL-25); total score > 1.75, OR
- Having elevated levels of psychological distress assessed by Kessler Psychological Distress Scale (K10); total score > 20
Who cannot join
- Suicidality assessed in self-report by the Suicide Behaviors Questionnaire-Revised (SBQ-R; total score > 6) and external report by telephone clarification
- Planning to leave Switzerland in the next 6 months
- Concurrent CBT-based skills-training similar to START NOW
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Psychiatric Clinics Basel
Basel, Canton of Basel-City, 4002
Janine Bacher, MSc, +410613258048, janine.bacher@upk.ch
Janine Bacher, MSc
About this study
Official title: Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees
The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants.
Read the detailed description
Over the last few decades, Europe has experienced one of the largest increases in international migration resulting from a combination of natural and man-made disasters. As these disasters cannot be expected to decrease in the future, it is essential to establish optimal healthcare for migrants, especially refugees. Due to several risk factors of their psychological well-being, refugees have higher prevalence rates of depression, post-traumatic stress disorder (PTSD) and other anxiety disorders compared to the host-country population. Adolescent refugees are particularly vulnerable to mental health problems, as they experience many risk factors associated with their resettlement during crucial phases of their physical and emotional development.
However, despite having a greater healthcare requirement than others, adolescent refugees encounter significant barriers in accessing healthcare services. The skills-training START NOW offers a low-threshold opportunity to treat this vulnerable population by promoting general psychological health and resilience.
Since effective psychological interventions are rooted in a cultural context and must be consistent with clients' cultural beliefs, there is a need to culturally adapt this existing intervention, which has previously been used with Western populations. Our study therefore aims to develop and evaluate a culturally adapted version of the existing START NOW skills-training.
The study is a monocentric, national, confirmatory randomized controlled trial with two arms, namely one intervention and one control group: 1) START NOW Adapted, 2) treatment as usual (TAU). Possible participants taking part in the intervention study are screened for eligibility. For those who are eligible, there will be three assessments: a baseline assessment (t1), a post-treatment assessment (t2), and a 12-weeks follow-up assessment (t3). Randomization into one of the two arms will take place after the baseline assessment (t1) has been conducted. Between t1 and t2, the intervention phase takes place over a period of ten weeks.
- Conditions
- Depression, Depression/Anxiety, Anxiety, Adolescent, Emotion Recognition, Mental Health
- Being tested
- START NOW Adapted
- Keywords
- randomized controlled trial, effectiveness trial, refugee health, cultural adaptation, skills-training, adolescent migrants
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START NOW AdaptedBehavioural
The START NOW skills-training combines aspects of cognitive behavioral therapy (CBT), motivational interviewing (MI), dialectical behavior therapy (DBT), Acceptance and Commitment Therapy (ACT) and trauma-sensitive care. Studies in different contexts have shown START NOW's effectiveness in terms of reducing behavioral problems, reducing hospitalization rates, improving mental health functioning and increasing satisfaction rates. The culturally adapted version will be contextually adapted to different cultural backgrounds and the experience of migration. In ten sessions, participants learn about emotions and are introduced to the START NOW skills. These skills, called "SLOW DOWN", "TAKE A STEP BACK", "ACCEPT", "RESPECT" and "TAKE ACTION", are strategies or techniques that can be used to better manage stress and difficult emotions.
| Study group | Role | What they receive |
|---|---|---|
| START NOW Adapted | Active comparator | The intervention group will receive a culturally adapted version of the yet well-validated START NOW training. The skills taught within START NOW aim to change dysfunctional negative attitudes and behaviour, improve emotion regulation capacities and enhance the ability to achieve individual goals by addressing key aspects of mental health and resilience. The training includes 10 group sessions including exercises and discussion.
The sessions will be held by a trained facilitator (staff member of institution, social worker, or else) with the same cultural background in the respective language (depending on group constellation) and supervised by a certified START NOW trainer from the START NOW team. Receives: Behavioral: START NOW Adapted |
| Treatment as Usual | No intervention | The control group will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in symptoms of depression and anxiety at the end of the intervention
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
Measured: From enrollment to the end of treatment at week 14
Change from baseline in symptoms of depression and anxiety at follow-up
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
Measured: From enrollment to follow-up at week 26
Secondary outcomes (6)
Change from baseline in self-reported perceived stress at follow-up
Perceived stress will be measured by the Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.
Measured: From enrollment to follow-up at week 26
Change from baseline in self-reported social-ecological resilience at the end of the intervention
Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.
Measured: From enrollment to the end of treatment at week 14
Change from baseline in self-reported perceived stress at the end of the intervention
Perceived stress will be measured by the Perceived Stress Scale (PSS-10). The PSS-10 is a 10-item self-report questionnaire including two subscales, on which participants report life as unpredictable, uncontrollable, and overloading over the previous month. Answers are given on a 5-point Likert Scale (0 = never, 4 = very often). Higher scores indicate higher levels of perceived stress. We chose perceived stress as a secondary endpoint because the many pre-, peri- and post-migration stressors that are risk factors for refugees' mental health could be better managed through the intervention aimed at improving distress tolerance.
Measured: From enrollment to the end of treatment at week 14
Change from baseline in self-reported social-ecological resilience at follow-up
Social-ecological resilience will be measured by the Child and Youth Resilience Measure (CYRM-R). The CYRM-R is a 17-item self-report questionnaire measuring resilience that has been validated in 11 different countries. Items include social integration and support, autonomy and fair treatment and can be answered on a 3- point Likert Scale (1 = no, 3 = yes). Higher scores hereby indicate more available protective factors and higher social-ecological resilience. We chose this secondary endpoint because it has often been used to assess the effectiveness of interventions in pre-post and longitudinal designs.
Measured: From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at the end of the intervention
Facial emotion recognition will be measured using the Penn Emotion Recognition Task (ER-40). The ER-40 consists of 40 colour photographs of static multicultural faces expressing four basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants quickly select the appropriate emotion label for each face. They then rate their confidence in the accuracy of their response on a scale from 0 (not at all confident) to 100 (extremely confident). Accuracy scores range from 0 to 40. The ER-40 has strong psychometric properties and is recommended for use in clinical trials. We included the secondary endpoint facial emotion recognition (ER) as performance on measures of emotion recognition is a first step in emotion regulation.
Measured: From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at follow-up
Facial emotion recognition will be measured using the Penn Emotion Recognition Task (ER-40). The ER-40 consists of 40 colour photographs of static multicultural faces expressing four basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants quickly select the appropriate emotion label for each face. They then rate their confidence in the accuracy of their response on a scale from 0 (not at all confident) to 100 (extremely confident). Accuracy scores range from 0 to 40. The ER-40 has strong psychometric properties and is recommended for use in clinical trials. We included the secondary endpoint facial emotion recognition (ER) as performance on measures of emotion recognition is a first step in emotion regulation.
Measured: From enrollment to follow-up at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start13 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Christina Stadler
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Prof. Christina Stadler, University Psychiatric Clinics Basel
- Investigators
- Janine Bacher, MSc, Principal investigator, University Psychiatric Clinics Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324864
- Sponsor's protocol ID
- 2024-00212
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stadler C, Freitag CM, Popma A, Nauta-Jansen L, Konrad K, Unternaehrer E, Ackermann K, Bernhard A, Martinelli A, Oldenhof H, Gundlach M, Kohls G, Pratzlich M, Kieser M, Limprecht R, Raschle NM, Vriends N, Trestman RL, Kirchner M, Kersten L. START NOW: a cognitive behavioral skills training for adolescent girls with conduct or oppositional defiant disorder - a randomized clinical trial. J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
PubMed 37814906Bacher J, Stadler C, Unternaehrer E, Brunner D. Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees: study protocol for a randomized controlled trial. Front Public Health. 2024 Jun 11;12:1408026. doi: 10.3389/fpubh.2024.1408026. eCollection 2024.
PubMed 38919921
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of the Culturally Adapted Skills Training START NOW to Reduce Mental Health Problems in Adolescent Refugees
- ClinicalTrials.gov ID
- NCT06324864
- Acronym / sponsor ID
- 2024-00212
- Conditions
- Depression, Depression/Anxiety, Anxiety, Adolescent, Emotion Recognition, Mental Health
- Keywords
- randomized controlled trial, effectiveness trial, refugee health, cultural adaptation, skills-training, adolescent migrants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Prof. Christina StadlerResearch network
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 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.
The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants.
Detailed description
Over the last few decades, Europe has experienced one of the largest increases in international migration resulting from a combination of natural and man-made disasters. As these disasters cannot be expected to decrease in the future, it is essential to establish optimal healthcare for migrants, especially refugees. Due to several risk factors of their psychological well-being, refugees have higher prevalence rates of depression, post-traumatic stress disorder (PTSD) and other anxiety disorders compared to the host-country population. Adolescent refugees are particularly vulnerable to mental health problems, as they experience many risk factors associated with their resettlement during crucial phases of their physical and emotional development.
However, despite having a greater healthcare requirement than others, adolescent refugees encounter significant barriers in accessing healthcare services. The skills-training START NOW offers a low-threshold opportunity to treat this vulnerable population by promoting general psychological health and resilience.
Since effective psychological interventions are rooted in a cultural context and must be consistent with clients' cultural beliefs, there is a need to culturally adapt this existing intervention, which has previously been used with Western populations. Our study therefore aims to develop and evaluate a culturally adapted version of the existing START NOW skills-training.
The study is a monocentric, national, confirmatory randomized controlled trial with two arms, namely one intervention and one control group: 1) START NOW Adapted, 2) treatment as usual (TAU). Possible participants taking part in the intervention study are screened for eligibility. For those who are eligible, there will be three assessments: a baseline assessment (t1), a post-treatment assessment (t2), and a 12-weeks follow-up assessment (t3). Randomization into one of the two arms will take place after the baseline assessment (t1) has been conducted. Between t1 and t2, the intervention phase takes place over a period of ten weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START NOW Adapted | Active comparator | Behavioral: START NOW AdaptedThe intervention group will receive a culturally adapted version of the yet well-validated START NOW training. The skills taught within START NOW aim to change dysfunctional negative attitudes and behaviour, improve emotion regulation capacities and enhance the ability to achieve individual goals by addressing key aspects of mental health and resilience. The training includes 10 group sessions including exercises and discussion. The sessions will be held by a trained facilitator (staff member of institution, social worker, or else) with the same cultural background in the respective language (depending on group constellation) and supervised by a certified START NOW trainer from the START NOW team. |
| Treatment as Usual | No intervention | –The control group will receive treatment as usual. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Being a migrant resettled in Switzerland temporarily or permanently
- Aged between 14 and 18
- Able to speak, read and understand one of the following languages: German, English, Turkish, Farsi, Dari, Ukrainian, Algerian Arabic or Pashto
- Able to give informed consent as documented by signature
- At least sub-clinical depressive symptoms assessed by the Hopkins Symptom Checklist-25 (HSCL-25); total score > 1.75, OR
Key exclusion criteria (3 listed)
- Suicidality assessed in self-report by the Suicide Behaviors Questionnaire-Revised (SBQ-R; total score > 6) and external report by telephone clarification
- Planning to leave Switzerland in the next 6 months
- Concurrent CBT-based skills-training similar to START NOW
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 |
|---|---|---|
| START NOW AdaptedThe START NOW skills-training combines aspects of cognitive behavioral therapy (CBT), motivational interviewing (MI), dialectical behavior therapy (DBT), Acceptance and Commitment Therapy (ACT) and trauma-sensitive care. Studies in different contexts have shown START NOW's effectiveness in terms of reducing behavioral problems, reducing hospitalization rates, improving mental health functioning and increasing satisfaction rates. The culturally adapted version will be contextually adapted to different cultural backgrounds and the experience of migration. In ten sessions, participants learn about emotions and are introduced to the START NOW skills. These skills, called "SLOW DOWN", "TAKE A STEP BACK", "ACCEPT", "RESPECT" and "TAKE ACTION", are strategies or techniques that can be used to better manage stress and difficult emotions. | Behavioural | START NOW Adapted |
Primary outcome
Change from baseline in symptoms of depression and anxiety at the end of the intervention
Time frame: From enrollment to the end of treatment at week 14
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
Change from baseline in symptoms of depression and anxiety at follow-up
Time frame: From enrollment to follow-up at week 26
Depression and anxiety will be measured by the Hopkins-Symptom-Checklist-25 (HSCL-25) questionnaire. The HSCL-25 is a 25-item self-report questionnaire, on which participants rate if physical, emotional, or psychological symptoms indicating depression, anxiety, and trauma have affected them over the past week. Answers are given on a 4-point Likert Scale (1 = not at all; 4 = extremely), and total scores can range from 25 to 100, with higher scores indicating greater levels of depression, anxiety and trauma, respectively. We chose symptoms of depression and anxiety as the primary endpoint because of their high self-reported prevalence of up to 42% in refugee populations.
6 secondary outcomes
Change from baseline in self-reported perceived stress at follow-up
Time frame: From enrollment to follow-up at week 26
Change from baseline in self-reported social-ecological resilience at the end of the intervention
Time frame: From enrollment to the end of treatment at week 14
Change from baseline in self-reported perceived stress at the end of the intervention
Time frame: From enrollment to the end of treatment at week 14
Change from baseline in self-reported social-ecological resilience at follow-up
Time frame: From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at the end of the intervention
Time frame: From enrollment to the end of treatment at week 14
Change from baseline in facial emotion recognition at follow-up
Time frame: From enrollment to follow-up at week 26
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 19 Feb 2026.
- Background: PubMed 37814906Stadler C, Freitag CM, Popma A, Nauta-Jansen L, Konrad K, Unternaehrer E, Ackermann K, Bernhard A, Martinelli A, Oldenhof H, Gundlach M, Kohls G, Pratzlich M, Kieser M, Limprecht R, Raschle NM, Vriends N, Trestman RL, Kirchner M, Kersten L. START NOW: a cognitive behavioral skills training for adolescent girls with conduct or oppositional defiant disorder - a randomized clinical trial. J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
- Results publication: PubMed 38919921Bacher J, Stadler C, Unternaehrer E, Brunner D. Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees: study protocol for a randomized controlled trial. Front Public Health. 2024 Jun 11;12:1408026. doi: 10.3389/fpubh.2024.1408026. eCollection 2024.
- 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.
Janine Bacher, MSc principal investigator
University Psychiatric Clinics Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START NOW Adapted in people with Depression and Depression/Anxiety, run by Prof. Christina Stadler at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 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 Switzerland. 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?
Contact Janine Bacher, MSc (+41 61 325 8048, janine.bacher@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptoms of depression and anxiety at the end of the intervention (time frame: From enrollment to the end of treatment at week 14). 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 NCT06324864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.