Mental Health IssueNCT05754723
Using an Online Psychotherapy Program and AI-assisted Interventions for Postsecondary Student Mental Health
A study testing e-Psychotherapy/Psychoeducation in people with Mental Health Issue, run by Dr. Nazanin Alavi at 1 site in Canada.
Trial summary
The prevalence of mental health challenges and disorders in post-secondary students, demands accessible and efficacious care. Online psychotherapy and psychoeducation programs have shown significant effectiveness in mitigating the risk and clinical symptoms of various mental health disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- e-Psychotherapy/Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2022to 6 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post-secondary students enrolled in institutions of interest
- the ability to provide informed consent
- the ability to speak and read English
- consistent and reliable access to the internet
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University, Hotel Dieu Hospital
Kingston, Ontario, K7L 3N6
About this study
Official title: Developing, Administering, and Evaluating Online Psychotherapy and Psychoeducation Programs for Postsecondary Students Within a Regional Mental Health Hub in Ontario, Canada Using AI-assisted Online Interventions
The prevalence of mental health challenges and disorders in post-secondary students, demands accessible and efficacious care. Online psychotherapy and psychoeducation programs have shown significant effectiveness in mitigating the risk and clinical symptoms of various mental health disorders. Additionally, artificial intelligence (AI) has become an accessible, effective, and scalable tool supporting the delivery of healthcare. Therefore, the primary objective of this study is to develop an AI-driven online mental health care hub in the Kingston, Frontenac, Lennox \& Addington region for post-secondary students. . This hub will deliver equitable, efficacious, and cost-effective online psychoeducation and psychotherapy in the form of online diagnosis-specific cognitive behavioural therapy (e-CBT). The hub's virtual design aims to adequately address existing gaps in the mental healthcare of these individuals and alleviate the burden placed on mental health services in Canada. Using a rigorous implementation framework, the development of this hub is designed as a multiphase study with three phases. (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups. This information will be used in the development of our online psychoeducation and diagnosis-specific e-CBT programs. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. (3) Post-adoption phase: the collected data from these programs will be analyzed and shared with key stakeholders to guide continuous program scaling and improvement.
Read the detailed description
The proposed regional mental healthcare hub aims to deliver equitable, efficacious, and cost-effective AI-driven online psychoeducation and diagnosis-specific online cognitive behavioural therapy (e-CBT) programs for post-secondary students in the Kingston, Frontenac, Lennox \& Addington (KFL\&A) region. The initiative will target a broad population of students ranging from those interested in learning more about mental health (online psychoeducation program) to those seeking additional help for their psychiatric symptoms (e-CBT program). Our research team is strongly experienced in designing effective AI-assisted online psychoeducation and diagnosis-specific e-CBT programs for various mental health conditions in diverse populations. Therefore, being as effective as in-person methods of healthcare delivery, it is hypothesized that our online interventions disseminated via a robust implementation science and community collaboration strategy will be a feasible, cost-effective, and pragmatic solution to address accessibility issues with post-secondary student mental healthcare.
The proposed mental health hub will offer a comprehensive care model using a stepped-care approach. Its implementation will be guided by a rigorous approach involving seven aims divided into three phases (pre-adoption, delivery, and post-adoption phases). (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups (Aim 1). This information will be used in the development of a 6-week online psychoeducation (Aim 2) and 12-week diagnosis-specific e-CBT (Aim 3) programs. The psychoeducation program will be followed by 6-months of AI-assisted journaling exercises to monitor the student's mental health and determine whether they would benefit from stepping up their care to receive the diagnosis-specific e-CBT program. The diagnosis-specific e-CBT programs will be adapted from prior clinically validated and diagnosis-specific psychotherapy modules developed by the lab. Four diagnosis-specific modules will support the most common mental health disorders in students (GAD, SAD, MDD and ADHD), as indicated by previous studies and the research team's cross-sectional survey of students in Ontario, Canada. Both programs will be delivered through the Online Psychotherapy Tool (OPTT) - a secure cloud-based platform co-developed by the PI that offers online mental health interventions. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation (Aim 4) and diagnosis-specific e-CBT (Aim 5) programs by comparing them to treatment, as usual, using validated clinical assessment tools. (3) Post-adoption phase: will use the collected data to monitor the success and fidelity of the programs using surveys and focus groups (Aim 6), and to build capacity and scale the project to other Canadian municipalities (Aim 7). As such, in contrast to other initiatives that target student mental health, this will be the first to involve students and end-users in all phases, from conception to implementation.
The digital nature of this healthcare program and the implementation of AI technology results in new solutions that enable easier accessibility and broader reach to individuals in significant need of mental healthcare services. Therefore, to support the development of these mental healthcare resources, the research team has assembled a diverse, cross-functional interdisciplinary team of community leaders, including researchers, clinicians, health decision-makers, and end-users. Ultimately, leveraging the extensive expertise of a cross-functional research team, the objective of the study is to develop and implement a successful and effective digital care plan with the potential to improve post-secondary student mental health care substantially.
- Conditions
- Mental Health Issue
- Being tested
- e-Psychotherapy/Psychoeducation
- Keywords
- Student, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Psychotherapy/PsychoeducationBehavioural
Participants will receive six weekly self-guided psychoeducation sessions. Then, after 6 weeks participants will complete monthly clinical questionnaires for 6 months. Also, participants will begin bi-weekly journaling exercises for 6 months. Based on the journaling entries, if the AI algorithm detects MDD, GAD, SAD or ADHD that requires treatment will make a referral to the diagnosis-specific e-CBT (MDD, GAD, SAD or ADHD). If after 6 months, no referral decision is made by the AI algorithm no extra follow-up will be provided. Once the AI makes a referral recommendation, participants will be placed in a diagnosis-specific e-CBT program specific to the diagnosis determined by the AI algorithm (MDD, GAD, SAD, or ADHD). The asynchronous e-CBT programs will consist of 12 weekly modules and homework. Weekly homework is reviewed by a therapist, who will provide personalized feedback based on the participant's preferred method (i.e., text, video, or audio).
| Study group | Role | What they receive |
|---|---|---|
| e-Psychotherapy | Experimental | Participants in the treatment group will receive access to the hub's services which begin with six weeks of online psychoeducation. Participants will be recruited through on-campus flyers, advertisements and wellness-center announcements, media advertisements, expert end-user referrals, and self-referrals. Participants will be excluded if they have active psychosis, acute mania, and/or active suicidal or homicidal ideation, and have received psychoeducation or psychotherapy like that offered by our proposed hub in the past six months. Participants with high disorder severity will be referred to other community resources determined by clinicians and therapists on the research team. Receives: Behavioral: e-Psychotherapy/Psychoeducation |
| Treatment as Usual | No intervention | TAU will consist of medications, regular physician or clinician visits, referrals or consultations that are conducted outside of the current research study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety severity (GAD-7)
Generalized anxiety disorder - 7 item (GAD-7) questionnaire. Increase in score dictates increase in severity. Scale of 0-3
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in depression severity (PHQ-9)
Patient Health Questionnaire - 9 item (PHQ-9). Increase in score dictates increase in severity. Scale of 0-3 on each question.
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in depression severity (QIDS)
Quick Inventory of Depressive Symptomatology (QIDS). Increase in score dictates increase in severity. Scale of 0-3 on each question
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in stress severity (DASS-42)
Depression Anxiety Stress Scale-42 (DASS-42). Increase in score dictates increase in severity. Scale of 0-3 on each question.
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in quality of life (AQoL-8D)
Assessment of Quality of Life-8D (AQoL-8D). Increase in score dictates increase in quality of life (improvement). Scale of 0-5 on each question.
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in resilience (RS-14)
Resilience Scale-14 (RS-14). Increase in score dictates increase in resilience (improvement). Scale of 0-7 on each question
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in social anxiety severity (LSAS)
Liebowitz Social Anxiety Scale (LSAS). Increase in score dictates increase in anxiety severity. Scale of 0-3 on each question.
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Change in ADHD severity (ASRS)
Adult ADHD Self-Report Scale (ASRS). Increase in score dictates increase in ADHD symptom severity. Scale of 0-5 on each question.
Measured: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start5 May 2022
- Primary completion1 Sep 2022
- Study completion6 Apr 2023
Why it stopped: Funding was not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Model description
- Aim 1 will assess post-secondary students' current mental health needs, through surveys and focus groups. Aims 2 and 3 will use the findings from the surveys and focus groups to inform the development of 6-week psychoeducation and 12-week diagnosis-specific e-CBT programs. The psychoeducation program will be followed by 6-months of AI-assisted journaling exercises to monitor the student's mental health and determine whether they would benefit from stepping up their care to receive the diagnosis-specific e-CBT program. Aims 4 and 5 will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. Aims 6 and 7 will use the data to monitor the success and fidelity of the programs using surveys and focus groups.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Nazanin Alavi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Nazanin Alavi, Queen's University
- Investigators
- Nazanin Alavi, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754723
- Sponsor's protocol ID
- 6034514
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing, Administering, and Evaluating Online Psychotherapy and Psychoeducation Programs for Postsecondary Students Within a Regional Mental Health Hub in Ontario, Canada Using AI-assisted Online Interventions
- ClinicalTrials.gov ID
- NCT05754723
- Acronym / sponsor ID
- 6034514
- Conditions
- Mental Health Issue
- Keywords
- Student, Mental Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Nazanin AlaviUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 6 Mar 2023 (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 prevalence of mental health challenges and disorders in post-secondary students, demands accessible and efficacious care. Online psychotherapy and psychoeducation programs have shown significant effectiveness in mitigating the risk and clinical symptoms of various mental health disorders. Additionally, artificial intelligence (AI) has become an accessible, effective, and scalable tool supporting the delivery of healthcare. Therefore, the primary objective of this study is to develop an AI-driven online mental health care hub in the Kingston, Frontenac, Lennox \& Addington region for post-secondary students. . This hub will deliver equitable, efficacious, and cost-effective online psychoeducation and psychotherapy in the form of online diagnosis-specific cognitive behavioural therapy (e-CBT). The hub's virtual design aims to adequately address existing gaps in the mental healthcare of these individuals and alleviate the burden placed on mental health services in Canada. Using a rigorous implementation framework, the development of this hub is designed as a multiphase study with three phases. (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups. This information will be used in the development of our online psychoeducation and diagnosis-specific e-CBT programs. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. (3) Post-adoption phase: the collected data from these programs will be analyzed and shared with key stakeholders to guide continuous program scaling and improvement.
Detailed description
The proposed regional mental healthcare hub aims to deliver equitable, efficacious, and cost-effective AI-driven online psychoeducation and diagnosis-specific online cognitive behavioural therapy (e-CBT) programs for post-secondary students in the Kingston, Frontenac, Lennox \& Addington (KFL\&A) region. The initiative will target a broad population of students ranging from those interested in learning more about mental health (online psychoeducation program) to those seeking additional help for their psychiatric symptoms (e-CBT program). Our research team is strongly experienced in designing effective AI-assisted online psychoeducation and diagnosis-specific e-CBT programs for various mental health conditions in diverse populations. Therefore, being as effective as in-person methods of healthcare delivery, it is hypothesized that our online interventions disseminated via a robust implementation science and community collaboration strategy will be a feasible, cost-effective, and pragmatic solution to address accessibility issues with post-secondary student mental healthcare.
The proposed mental health hub will offer a comprehensive care model using a stepped-care approach. Its implementation will be guided by a rigorous approach involving seven aims divided into three phases (pre-adoption, delivery, and post-adoption phases). (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups (Aim 1). This information will be used in the development of a 6-week online psychoeducation (Aim 2) and 12-week diagnosis-specific e-CBT (Aim 3) programs. The psychoeducation program will be followed by 6-months of AI-assisted journaling exercises to monitor the student's mental health and determine whether they would benefit from stepping up their care to receive the diagnosis-specific e-CBT program. The diagnosis-specific e-CBT programs will be adapted from prior clinically validated and diagnosis-specific psychotherapy modules developed by the lab. Four diagnosis-specific modules will support the most common mental health disorders in students (GAD, SAD, MDD and ADHD), as indicated by previous studies and the research team's cross-sectional survey of students in Ontario, Canada. Both programs will be delivered through the Online Psychotherapy Tool (OPTT) - a secure cloud-based platform co-developed by the PI that offers online mental health interventions. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation (Aim 4) and diagnosis-specific e-CBT (Aim 5) programs by comparing them to treatment, as usual, using validated clinical assessment tools. (3) Post-adoption phase: will use the collected data to monitor the success and fidelity of the programs using surveys and focus groups (Aim 6), and to build capacity and scale the project to other Canadian municipalities (Aim 7). As such, in contrast to other initiatives that target student mental health, this will be the first to involve students and end-users in all phases, from conception to implementation.
The digital nature of this healthcare program and the implementation of AI technology results in new solutions that enable easier accessibility and broader reach to individuals in significant need of mental healthcare services. Therefore, to support the development of these mental healthcare resources, the research team has assembled a diverse, cross-functional interdisciplinary team of community leaders, including researchers, clinicians, health decision-makers, and end-users. Ultimately, leveraging the extensive expertise of a cross-functional research team, the objective of the study is to develop and implement a successful and effective digital care plan with the potential to improve post-secondary student mental health care substantially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aim 1 will assess post-secondary students' current mental health needs, through surveys and focus groups. Aims 2 and 3 will use the findings from the surveys and focus groups to inform the development of 6-week psychoeducation and 12-week diagnosis-specific e-CBT programs. The psychoeducation program will be followed by 6-months of AI-assisted journaling exercises to monitor the student's mental health and determine whether they would benefit from stepping up their care to receive the diagnosis-specific e-CBT program. Aims 4 and 5 will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. Aims 6 and 7 will use the data to monitor the success and fidelity of the programs using surveys and focus groups.
| Arm | Type | Receives |
|---|---|---|
| e-Psychotherapy | Experimental | Behavioral: e-Psychotherapy/PsychoeducationParticipants in the treatment group will receive access to the hub's services which begin with six weeks of online psychoeducation. Participants will be recruited through on-campus flyers, advertisements and wellness-center announcements, media advertisements, expert end-user referrals, and self-referrals. Participants will be excluded if they have active psychosis, acute mania, and/or active suicidal or homicidal ideation, and have received psychoeducation or psychotherapy like that offered by our proposed hub in the past six months. Participants with high disorder severity will be referred to other community resources determined by clinicians and therapists on the research team. |
| Treatment as Usual | No intervention | –TAU will consist of medications, regular physician or clinician visits, referrals or consultations that are conducted outside of the current research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post-secondary students enrolled in institutions of interest
- the ability to provide informed consent
- the ability to speak and read English
- consistent and reliable access to the internet
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| e-Psychotherapy/PsychoeducationParticipants will receive six weekly self-guided psychoeducation sessions. Then, after 6 weeks participants will complete monthly clinical questionnaires for 6 months. Also, participants will begin bi-weekly journaling exercises for 6 months. Based on the journaling entries, if the AI algorithm detects MDD, GAD, SAD or ADHD that requires treatment will make a referral to the diagnosis-specific e-CBT (MDD, GAD, SAD or ADHD). If after 6 months, no referral decision is made by the AI algorithm no extra follow-up will be provided. Once the AI makes a referral recommendation, participants will be placed in a diagnosis-specific e-CBT program specific to the diagnosis determined by the AI algorithm (MDD, GAD, SAD, or ADHD). The asynchronous e-CBT programs will consist of 12 weekly modules and homework. Weekly homework is reviewed by a therapist, who will provide personalized feedback based on the participant's preferred method (i.e., text, video, or audio). | Behavioural | e-Psychotherapy |
Primary outcome
Change in anxiety severity (GAD-7)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Generalized anxiety disorder - 7 item (GAD-7) questionnaire. Increase in score dictates increase in severity. Scale of 0-3
Change in depression severity (PHQ-9)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Patient Health Questionnaire - 9 item (PHQ-9). Increase in score dictates increase in severity. Scale of 0-3 on each question.
Change in depression severity (QIDS)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Quick Inventory of Depressive Symptomatology (QIDS). Increase in score dictates increase in severity. Scale of 0-3 on each question
Change in stress severity (DASS-42)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Depression Anxiety Stress Scale-42 (DASS-42). Increase in score dictates increase in severity. Scale of 0-3 on each question.
Change in quality of life (AQoL-8D)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Assessment of Quality of Life-8D (AQoL-8D). Increase in score dictates increase in quality of life (improvement). Scale of 0-5 on each question.
Change in resilience (RS-14)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Resilience Scale-14 (RS-14). Increase in score dictates increase in resilience (improvement). Scale of 0-7 on each question
Change in social anxiety severity (LSAS)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Liebowitz Social Anxiety Scale (LSAS). Increase in score dictates increase in anxiety severity. Scale of 0-3 on each question.
Change in ADHD severity (ASRS)
Time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months
Adult ADHD Self-Report Scale (ASRS). Increase in score dictates increase in ADHD symptom severity. Scale of 0-5 on each question.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon request
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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.
Nazanin Alavi, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Psychotherapy/Psychoeducation in people with Mental Health Issue, run by Dr. Nazanin Alavi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in anxiety severity (GAD-7) (time frame: weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.