Emotion RegulationNCT05576883
Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students
A study testing Transdiagnostic emotion regulation intervention in people with Emotion Regulation and Stress, run by Erasmus University Rotterdam at 1 site in Netherlands.
Trial summary
This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Stress, Depressive Symptoms
- What is being tested?
- Transdiagnostic emotion regulation intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2023to 13 Jun 2023
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to provide informed consent
- Currently enrolled as a student at the Erasmus University Rotterdam
- Own a smartphone with an active phone number
- Feel comfortable speaking and writing in the English language
- Having a score between 5 (mild) and 19 (moderately severe) on the PHQ-9
Who cannot join
- Participants are not eligible for this study if they:
- Experience significant suicidal thoughts over the past month
- Have a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
- Are undergoing psychopharmacological treatment or treatment with experimental drugs
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Rotterdam
Rotterdam, South Holland, 3062 PA
About this study
Official title: Optimizing a Mobile Transdiagnostic Emotion Regulation Intervention for University Students: A Micro Randomized Trial
This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.
Read the detailed description
It is estimated that globally between 12 and 50% of all university students are affected by mental health problems, the most common ones being anxiety, depression, and substance abuse. Over the past years online-based interventions have been spotlighted by researchers and clinicians as an avenue for a better outreach and provision of low threshold interventions aimed at primary and secondary prevention of mental health problems among the university students population.
As part of a student wellbeing program at the Erasmus University Rotterdam (EUR), a transdiagnostic mobile intervention consisting of a suite of preventative self-guided tools is being developed. Its' goal is to help students better manage their mental health by teaching them adaptive emotional regulation strategies.
The intervention includes exercises from different therapeutic approaches, and targets transdiagnostic factors such as negative self-referential thoughts, rumination, experiences of prolonged negative emotional states, and mental health literacy. The intervention is delivered via a smartphone and consists of 20 therapeutic exercises teaching students strategies like upregulation of positive affect, staying present in the moment, cognitive defusion, relaxation and breathing techniques, and self compassion skills.
The main goals of the study are to evaluate whether the intervention and its components have the intended effects on student's emotional states as well as get insight into students' engagement patterns and experience with the intervention. This will be done by utilizing an explanatory sequential mixed methods approach combining novel methods of online-intervention assessment, specifically Micro Randomized Trials (MRT) with semi-structured interviews, which will provide information on the lived experiences of the participants with the intervention and provide explanation of the quantitative results. The results of this trial will support the optimization and further development of the mobile application that will later be evaluated for its full-scale effectiveness.
- Conditions
- Emotion Regulation, Stress, Depressive Symptoms, Anxiety
- Being tested
- Transdiagnostic emotion regulation intervention
- Keywords
- Transdiagnostic intervention, Micro Randomized Trials, User research, Mental health, University Students
- Medical subject headings
- Emotional Regulation, 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.
Transdiagnostic emotion regulation interventionBehavioural
The intervention under study includes 5 therapeutic approaches, namely: Positive psychology [PP], Mindfulness, Acceptance and Commitment Therapy [ACT], Breathing and relaxation, and Self-compassion [SC].
The intervention consists of 4 core features:
(i) monitoring through filling in EMAs assessing participants emotional states
(ii) feedback through visualization of participant emotional states upon every completion of the EMAs
(iii) exercises targeting different emotion regulation skills [i.e., upregulation of positive affect, mindfulness, cognitive defusion, breathing and relaxation, self-compassion) and health facts (i.e., control intervention) describing health information including nutrition, exercise, sleeping habits.
(iv) psychoeducative articles describing the 5 therapeutic approaches (PP, ACT, Mindfulness, Breathing and Relaxation, SC)
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Intervention and Control Intervention | Other | Participants will be asked in the morning and in the evening at their self-selected time to evaluate their emotional state through ecological momentary assessment (EMA) and will be prompted to engage in an ER intervention (60% likelihood) or to read health information (40% likelihood). Upon completion they will evaluate the likability and helpfulness of the exercise or the article and re-evaluate their emotional state (post-EMA).
The intervention consists of 20 ER exercises and 20 health facts. The ER intervention is based on different therapeutic approaches targeting various underlying transdiagnostic factors such as rumination, self-referential thoughts etc. The 20 health facts will act as a placebo intervention with no effect on emotion regulation and keep participants engaged in the post-EMA evaluation when they are not randomized to an exercise.
The interventions and the control intervention materials were developed by the research team for the purposes of this study. Receives: Behavioral: Transdiagnostic emotion regulation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in a momentary emotional state
Participants will be asked to evaluate seven emotional states before and after engaging in the ER intervention or control intervention by answering the question: "How [affect (e.g., happy)] do you feel at the moment?" Each of 7 emotional states is evaluated on a scale from 1 [Not at all] to 5 [Extremely]. The emotional states are combined into 2 categories of affect: negative (stressed, frustrated, sad, fatigued) and positive (happy, energetic, relaxed).
Changes in the momentary emotional states (i.e., positive and negative affect) will be evaluated by looking at the responses on the pre and post EMA in the relation to whether a participant received an ER intervention or health information.
Measured: Day 2 - day 22
Changes in thought believability and discomfort after engaging in CD exercise
When randomized to CD exercise, participants will be asked to evaluate their self-selected unhelpful thought answering the following questions on a scale from 1 (not at all uncomfortable/believable) to 100 (extremely uncomfortable / believable) before and after the exercise:
"How uncomfortable is the thought?" "How believable (true) is the thought?"
The effects of CD exercises will be assessed by comparing the pre and post scores on the two thought parameters.
Measured: Day 2 - day 22
Objective engagement patterns: Engagement metrics
Objective engagement patterns with the intervention will be assessed using descriptive statistics of engagement metrics (i.e., exercise completion rates, average time spent, and times of the day where participants completed the exercises) per exercise and exercise category. In addition, a correlational analysis will be used to evaluate whether there is a relationship between time of the day and exercise completion rates.
Measured: Day 2 - day 22
Objective engagement patterns: Relationship between time of the day and exercise completion
A correlational analysis will be used to evaluate whether there is a relationship between the time of the day participants engaged in an exercise and exercise completion rates.
Measured: Day 2 - day 22
Subjective engagement patterns: Exercise likeability and helpfulness
Subjective engagement patterns will be evaluated by combining exercise likeability and helpfulness ratings with information from the semi-structured interviews.
Exercise likeability and helpfulness are assessed with items rated on a scale from 1 (not at all) to 5 (very much):
"How much did you like the exercise?" "How helpful did you find the exercise?"
Measured: Day 2 - day 22
Subjective engagement patterns: User experience
Semi-structured interviews will be conducted with a subsample of participants (n=21) within three weeks upon completion of the MRT. University students will be asked to report on their general experience with intervention as well as intervention categories and separate exercises. Example questions are: "What do you think about the intervention?", "What kind of difficulties did you experience while using it?",
Measured: Up to 3 weeks upon completion of the Micro Randomized Trial
Secondary outcomes (4)
Changes in ER skills
ER skills will be measured with the Emotion Regulation Skills Questionnaire [ERSQ] that evaluates seven types of ER skills: awareness, sensation, clarity, understanding, acceptance, tolerance, compassionate self-support, readiness to confront distressing situations, and modification of negative emotions. The 27 items are rated on a scale from 0 [ not at all ] to 4 [ almost always ]. Higher scores on the ERSQ subscales and the overall ERSQ score indicate higher ER skills.
Measured: At the baseline and day 23
Changes in Anxiety symptoms
Symptoms of anxiety will be measured with the Generalized Anxiety Disorder questionnaire [GAD-7] Participants will indicate how often they have been bothered by different symptoms over the last two weeks on a scale from 0 (not at all) to 3 (nearly every day). The summed scores for GAD-7 range between 0-21, with higher scores indicating higher levels of depression and anxiety symptoms
Measured: At the baseline and day 23
Changes in Depressive symptoms
Symptoms of depression will be measured with the Patient Health Questionnaire [PHQ-9]. Participants will indicate how often they have been bothered by different symptoms over the last two weeks on a scale from 0 (not at all) to 3 (nearly every day). The summed scores for PHQ range from 0-27, with higher scores indicating higher levels of depression and anxiety symptoms
Measured: At the baseline and day 23
Changes in stress levels
Perceived Stress Scale [PSS-10] will be used to assess stress levels. Participants will be asked to indicate how often they felt or thought a certain way over the last month on a scale from 0 [never] to 5 [very often]. The summed score ranges from 0 - 40, with higher scores indicating higher levels of perceived stress symptoms.
Measured: At the baseline and day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Feb 2023
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
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 Emotion RegulationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilizes a Micro Randomized Trial \[MRT\] method to evaluate the effects of the intervention. Compared to a multi-arm trial, in which participants are randomized to an intervention or control group, in an MRT individuals are randomized repeatedly to different interventions during the trial which allows for a large number of observations of the targeted proximal outcome(s) per participant (in this case, emotional states). This design also allows us to investigate contextual moderators of proximal effects such as time of intervention delivery and emotional state.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus University Rotterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilisa Boffo, Erasmus University Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576883
- Sponsor's protocol ID
- ETH2122-0677
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data \[and code\] produced in the project will be shared in a research data repository \[EUR Data Repository (EDR) and Open Science Framework (OSF)\]. A DCMI \[Dublin Core Metadata Initiative\] standard will be used to document this research. There will be a temporary restriction on re-using of the data (Embargo period of 6 months). Data \[and code\] that will be shared in a research data repository are: Anonymized survey data, Codebook and Blank Questionnaires, Readme text file (general description of the data, including date of collection, selection procedure of participants, tools used to collect the data etc.), and scripts of data analysis.
Publications
Laure T, Engels RCME, Remmerswaal D, Spruijt-Metz D, Konigorski S, Boffo M. Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603.
PubMed 37889525Laure T, Villegas Meija C, Remmerswaal D, Dulloo D, Van der Hallen R, Mayer B, Littel M, Dierckx B, Legerstee JS, Engels RCME, Boffo M. ROOM to Grow, a Mobile Well-Being Intervention for University Students: Overview of the Design Process and Outcomes. JMIR Form Res. 2025 Dec 17;9:e63325. doi: 10.2196/63325.
PubMed 41406474
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Mobile Transdiagnostic Emotion Regulation Intervention for University Students: A Micro Randomized Trial
- ClinicalTrials.gov ID
- NCT05576883
- Acronym / sponsor ID
- ETH2122-0677
- Conditions
- Emotion Regulation, Stress, Depressive Symptoms, Anxiety
- Keywords
- Transdiagnostic intervention, Micro Randomized Trials, User research, Mental health, University Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Erasmus University RotterdamUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 13 Oct 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.
This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.
Detailed description
It is estimated that globally between 12 and 50% of all university students are affected by mental health problems, the most common ones being anxiety, depression, and substance abuse. Over the past years online-based interventions have been spotlighted by researchers and clinicians as an avenue for a better outreach and provision of low threshold interventions aimed at primary and secondary prevention of mental health problems among the university students population.
As part of a student wellbeing program at the Erasmus University Rotterdam (EUR), a transdiagnostic mobile intervention consisting of a suite of preventative self-guided tools is being developed. Its' goal is to help students better manage their mental health by teaching them adaptive emotional regulation strategies.
The intervention includes exercises from different therapeutic approaches, and targets transdiagnostic factors such as negative self-referential thoughts, rumination, experiences of prolonged negative emotional states, and mental health literacy. The intervention is delivered via a smartphone and consists of 20 therapeutic exercises teaching students strategies like upregulation of positive affect, staying present in the moment, cognitive defusion, relaxation and breathing techniques, and self compassion skills.
The main goals of the study are to evaluate whether the intervention and its components have the intended effects on student's emotional states as well as get insight into students' engagement patterns and experience with the intervention. This will be done by utilizing an explanatory sequential mixed methods approach combining novel methods of online-intervention assessment, specifically Micro Randomized Trials (MRT) with semi-structured interviews, which will provide information on the lived experiences of the participants with the intervention and provide explanation of the quantitative results. The results of this trial will support the optimization and further development of the mobile application that will later be evaluated for its full-scale effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a Micro Randomized Trial [MRT] method to evaluate the effects of the intervention. Compared to a multi-arm trial, in which participants are randomized to an intervention or control group, in an MRT individuals are randomized repeatedly to different interventions during the trial which allows for a large number of observations of the targeted proximal outcome(s) per participant (in this case, emotional states). This design also allows us to investigate contextual moderators of proximal effects such as time of intervention delivery and emotional state.
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Intervention and Control Intervention | Other | Behavioral: Transdiagnostic emotion regulation interventionParticipants will be asked in the morning and in the evening at their self-selected time to evaluate their emotional state through ecological momentary assessment (EMA) and will be prompted to engage in an ER intervention (60% likelihood) or to read health information (40% likelihood). Upon completion they will evaluate the likability and helpfulness of the exercise or the article and re-evaluate their emotional state (post-EMA). The intervention consists of 20 ER exercises and 20 health facts. The ER intervention is based on different therapeutic approaches targeting various underlying transdiagnostic factors such as rumination, self-referential thoughts etc. The 20 health facts will act as a placebo intervention with no effect on emotion regulation and keep participants engaged in the post-EMA evaluation when they are not randomized to an exercise. The interventions and the control intervention materials were developed by the research team for the purposes of this study. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to provide informed consent
- Currently enrolled as a student at the Erasmus University Rotterdam
- Own a smartphone with an active phone number
- Feel comfortable speaking and writing in the English language
- Having a score between 5 (mild) and 19 (moderately severe) on the PHQ-9
Key exclusion criteria (4 listed)
- Experience significant suicidal thoughts over the past month
- Have a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
- Are undergoing psychopharmacological treatment or treatment with experimental drugs
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 |
|---|---|---|
| Transdiagnostic emotion regulation interventionThe intervention under study includes 5 therapeutic approaches, namely: Positive psychology [PP], Mindfulness, Acceptance and Commitment Therapy [ACT], Breathing and relaxation, and Self-compassion [SC]. The intervention consists of 4 core features: (i) monitoring through filling in EMAs assessing participants emotional states (ii) feedback through visualization of participant emotional states upon every completion of the EMAs (iii) exercises targeting different emotion regulation skills [i.e., upregulation of positive affect, mindfulness, cognitive defusion, breathing and relaxation, self-compassion) and health facts (i.e., control intervention) describing health information including nutrition, exercise, sleeping habits. (iv) psychoeducative articles describing the 5 therapeutic approaches (PP, ACT, Mindfulness, Breathing and Relaxation, SC) | Behavioural | Emotion Regulation Intervention and Control Intervention |
Primary outcome
Changes in a momentary emotional state
Time frame: Day 2 - day 22
Participants will be asked to evaluate seven emotional states before and after engaging in the ER intervention or control intervention by answering the question: "How [affect (e.g., happy)] do you feel at the moment?" Each of 7 emotional states is evaluated on a scale from 1 [Not at all] to 5 [Extremely]. The emotional states are combined into 2 categories of affect: negative (stressed, frustrated, sad, fatigued) and positive (happy, energetic, relaxed). Changes in the momentary emotional states (i.e., positive and negative affect) will be evaluated by looking at the responses on the pre and post EMA in the relation to whether a participant received an ER intervention or health information.
Changes in thought believability and discomfort after engaging in CD exercise
Time frame: Day 2 - day 22
When randomized to CD exercise, participants will be asked to evaluate their self-selected unhelpful thought answering the following questions on a scale from 1 (not at all uncomfortable/believable) to 100 (extremely uncomfortable / believable) before and after the exercise: "How uncomfortable is the thought?" "How believable (true) is the thought?" The effects of CD exercises will be assessed by comparing the pre and post scores on the two thought parameters.
Objective engagement patterns: Engagement metrics
Time frame: Day 2 - day 22
Objective engagement patterns with the intervention will be assessed using descriptive statistics of engagement metrics (i.e., exercise completion rates, average time spent, and times of the day where participants completed the exercises) per exercise and exercise category. In addition, a correlational analysis will be used to evaluate whether there is a relationship between time of the day and exercise completion rates.
Objective engagement patterns: Relationship between time of the day and exercise completion
Time frame: Day 2 - day 22
A correlational analysis will be used to evaluate whether there is a relationship between the time of the day participants engaged in an exercise and exercise completion rates.
Subjective engagement patterns: Exercise likeability and helpfulness
Time frame: Day 2 - day 22
Subjective engagement patterns will be evaluated by combining exercise likeability and helpfulness ratings with information from the semi-structured interviews. Exercise likeability and helpfulness are assessed with items rated on a scale from 1 (not at all) to 5 (very much): "How much did you like the exercise?" "How helpful did you find the exercise?"
Subjective engagement patterns: User experience
Time frame: Up to 3 weeks upon completion of the Micro Randomized Trial
Semi-structured interviews will be conducted with a subsample of participants (n=21) within three weeks upon completion of the MRT. University students will be asked to report on their general experience with intervention as well as intervention categories and separate exercises. Example questions are: "What do you think about the intervention?", "What kind of difficulties did you experience while using it?",
4 secondary outcomes
Changes in ER skills
Time frame: At the baseline and day 23
Changes in Anxiety symptoms
Time frame: At the baseline and day 23
Changes in Depressive symptoms
Time frame: At the baseline and day 23
Changes in stress levels
Time frame: At the baseline and day 23
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 17 Jan 2024.
- Background: PubMed 37889525Laure T, Engels RCME, Remmerswaal D, Spruijt-Metz D, Konigorski S, Boffo M. Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603.
- Derived from this study: PubMed 41406474Laure T, Villegas Meija C, Remmerswaal D, Dulloo D, Van der Hallen R, Mayer B, Littel M, Dierckx B, Legerstee JS, Engels RCME, Boffo M. ROOM to Grow, a Mobile Well-Being Intervention for University Students: Overview of the Design Process and Outcomes. JMIR Form Res. 2025 Dec 17;9:e63325. doi: 10.2196/63325.
- Study Pre-printLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data [and code] produced in the project will be shared in a research data repository [EUR Data Repository (EDR) and Open Science Framework (OSF)]. A DCMI [Dublin Core Metadata Initiative] standard will be used to document this research. There will be a temporary restriction on re-using of the data (Embargo period of 6 months). Data [and code] that will be shared in a research data repository are: Anonymized survey data, Codebook and Blank Questionnaires, Readme text file (general description of the data, including date of collection, selection procedure of participants, tools used to collect the data etc.), and scripts of data analysis.
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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 Transdiagnostic emotion regulation intervention in people with Emotion Regulation and Stress, run by Erasmus University Rotterdam at 1 site in Netherlands.
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 5 inclusion and 4 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 17 Jan 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 Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in a momentary emotional state (time frame: Day 2 - day 22). The study lists 6 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 NCT05576883, 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 17 Jan 2024.