SuicideSWEEPNCT06349915
A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
A study testing Supporting Wellbeing with Everyday Experiences of Peers (SWEEP) in people with Suicide, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Suicide
- What is being tested?
- Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2028
- 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
- past-month history of suicidal thoughts
- past-month history of Major depressive disorder
- possession of apple or android smartphone with data plan
Who cannot join
- inability to read/write in English
- Active mania
- Active psychosis
- Autism spectrum disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Health System
The Bronx, New York, 10467
About this study
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.
Read the detailed description
This is a single-arm investigation of a novel suicide prevention intervention, called "Supporting Wellbeing with Everyday Experiences of Peers" (SWEEP). In a preliminary phase (Phase 1) of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from Bronx Adolescents will be collected. The investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. In a subsequent phase (Phase 2), adolescent participants (n=46) will be provided with the SWEEP intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. Six of the 46 participants will be adolescents, with recent suicidal thoughts or depression, who are currently receiving mental healthcare in Montefiore's Outpatient Psychiatry Department, rather than those on the waitlist to receive these services. All six participants will then complete a post-intervention qualitative interview to inform potential changes to intervention procedures. During this second phase, suicide recovery narratives will be provided, in audio and text formats, via a smartphone app. That same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, as well as secondary and additional outcomes, five times per day. The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial. During Phase 3, participants will be recruited to a control condition (n=15) and a treatment condition (n=30). Those in the Phase 3 treatment condition will receive the same intervention (1 SWEEP narrative per day for 14 days + 3x/day EMA) as those in Phase 2. Those in the Control condition will receive 3x/day EMA only.
A recent amendment approved by the IRB decreased the maximum response time for follow-up after participants report an adverse event from 24 hours to 12 hours.
- Conditions
- Suicide
- Being tested
- Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)
- Keywords
- digital intervention, community participation, ecological momentary assessment
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)Behavioural
Also called SWEEP
Each day during a 14-day trial period, participants will receive one narrative featuring lived experience with and recovery from suicidal thoughts and behaviors. These narratives will be presented in audio and text format via a smartphone app. Participants will also complete self-report surveys assessing study outcomes using the same smartphone app five times per day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a single-arm study. All participants will be allocated to the intervention arm, in which they will receive the digital narrative therapy. Receives: Behavioral: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Thoughts
Participants will self-report their current subjective intensity of suicidal thoughts using an 11-point Likert-type scale, with higher scores indicating more intense suicidal thoughts.
Measured: 5 times per day during 14-day trial
Secondary outcomes (5)
Suicidal Urge Resistance
Participants will self-report the strength of their current ability to resist suicidal urges using an 11-point Likert-type scale, with higher scores indicating greater ability to resist suicidal urges.
Measured: 5 times per day during 14-day trial
Social Connectedness
Participants will self-report their current feelings of being connected to other people using an 11-point Likert-type scale, with higher scores indicating feeling more being connected to other people.
Measured: 5 times per day during 14-day trial
Optimism
Participants will self-report their current of feelings of optimism about the future using an 11-point Likert-type scale, with higher scores indicating greater optimism.
Measured: 5 times per day during 14-day trial
Social Support
Participants will self-report their current perception of the availability of emotional support from others using an 11-point Likert-type scale, with higher scores indicating the perception greater availability of emotional support from others.
Measured: 5 times per day during 14-day trial
Intervention Acceptability
Participants will self-report their current perception of acceptability of the SWEEP intervention across three items. Participants will rate the usefulness of receiving the narratives using a 7-point Likert-type scale, with higher scores indicating that the narratives were more useful. Participants will rate the difficulty of reading or listening to the narratives each day using a 7-point Likert-type scale, with higher scores indicating that the narratives were more difficult to read or listen to. This item will be reverse coded. Participants will rate how willing they are to recommend the narratives to their peers using a 7-point Likert-type scale, with higher scores indicating greater willingness to recommend the narratives. Each of these items will be evaluated in isolation, as well as in aggregate using both summation and an arithmetic mean score.
Measured: Study conclusion (at the end of the 14-day trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, Yeshiva University, Ilumivu
- Responsible party
- Sponsor
- Investigators
- Peter J Franz, Ph.D., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349915
- Sponsor's protocol ID
- 2023-15217
- Other IDs
- 2023
- Acronym
- SWEEP
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team will consider requests to share specific data with qualified research teams upon request
Publications
Franz PJ, Mou D, Kessler DT, Stubbing J, Jaroszewski AC, Ray S, Cao-Silveira VB, Bachman S, Schuster S, Graupensperger D, Alpert JE, Porath M, Nock MK. Digital bibliotherapy as a scalable intervention for suicidal thoughts: A randomized controlled trial. J Consult Clin Psychol. 2022 Aug;90(8):626-637. doi: 10.1037/ccp0000752.
PubMed 36066864Centers for Disease Control and Prevention. 10 leading causes of death, United States. WISQARS Fatal Injury Data Visualization Tool.
Fox KR, Huang X, Guzman EM, Funsch KM, Cha CB, Ribeiro JD, Franklin JC. Interventions for suicide and self-injury: A meta-analysis of randomized controlled trials across nearly 50 years of research. Psychol Bull. 2020 Dec;146(12):1117-1145. doi: 10.1037/bul0000305. Epub 2020 Oct 29.
PubMed 33119344Alvarez K, Polanco-Roman L, Samuel Breslow A, Molock S. Structural Racism and Suicide Prevention for Ethnoracially Minoritized Youth: A Conceptual Framework and Illustration Across Systems. Am J Psychiatry. 2022 Jun;179(6):422-433. doi: 10.1176/appi.ajp.21101001.
PubMed 35599542Bray MJC, Daneshvari NO, Radhakrishnan I, Cubbage J, Eagle M, Southall P, Nestadt PS. Racial Differences in Statewide Suicide Mortality Trends in Maryland During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Psychiatry. 2021 Apr 1;78(4):444-447. doi: 10.1001/jamapsychiatry.2020.3938.
PubMed 33325985Weimerskirch PJ. Benjamin Rush and John Minson Galt, II. Pioneers of bibliotherapy in America. Bull Med Libr Assoc. 1965 Oct;53(4):510-26.
PubMed 5319266Stip E, Ostlundh L, Abdel Aziz K. Bibliotherapy: Reading OVID During COVID. Front Psychiatry. 2020 Dec 7;11:567539. doi: 10.3389/fpsyt.2020.567539. eCollection 2020.
PubMed 33364987Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25. doi: 10.1017/s003329179800765x.
PubMed 10077290Gualano MR, Bert F, Martorana M, Voglino G, Andriolo V, Thomas R, Gramaglia C, Zeppegno P, Siliquini R. The long-term effects of bibliotherapy in depression treatment: Systematic review of randomized clinical trials. Clin Psychol Rev. 2017 Dec;58:49-58. doi: 10.1016/j.cpr.2017.09.006. Epub 2017 Sep 29.
PubMed 28993103Bietti LM, Tilston O, Bangerter A. Storytelling as Adaptive Collective Sensemaking. Top Cogn Sci. 2019 Oct;11(4):710-732. doi: 10.1111/tops.12358. Epub 2018 Jun 28.
PubMed 29954043Rennick-Egglestone S, Morgan K, Llewellyn-Beardsley J, Ramsay A, McGranahan R, Gillard S, Hui A, Ng F, Schneider J, Booth S, Pinfold V, Davidson L, Franklin D, Bradstreet S, Arbour S, Slade M. Mental Health Recovery Narratives and Their Impact on Recipients: Systematic Review and Narrative Synthesis. Can J Psychiatry. 2019 Oct;64(10):669-679. doi: 10.1177/0706743719846108. Epub 2019 May 2.
PubMed 31046432Van Orden KA, Witte TK, Cukrowicz KC, Braithwaite SR, Selby EA, Joiner TE Jr. The interpersonal theory of suicide. Psychol Rev. 2010 Apr;117(2):575-600. doi: 10.1037/a0018697.
PubMed 20438238Joiner T. Why People Die by Suicide. Harvard University Press; 2005.
Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
PubMed 23303463Millner AJ, Lee MD, Nock MK. Describing and Measuring the Pathway to Suicide Attempts: A Preliminary Study. Suicide Life Threat Behav. 2017 Jun;47(3):353-369. doi: 10.1111/sltb.12284. Epub 2016 Aug 1.
PubMed 27477787
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
- ClinicalTrials.gov ID
- NCT06349915
- Acronym / sponsor ID
- SWEEP / 2023-15217
- Conditions
- Suicide
- Keywords
- digital intervention, community participation, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, Yeshiva University, Ilumivu
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Apr 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.
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.
Detailed description
This is a single-arm investigation of a novel suicide prevention intervention, called "Supporting Wellbeing with Everyday Experiences of Peers" (SWEEP). In a preliminary phase (Phase 1) of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from Bronx Adolescents will be collected. The investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. In a subsequent phase (Phase 2), adolescent participants (n=46) will be provided with the SWEEP intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. Six of the 46 participants will be adolescents, with recent suicidal thoughts or depression, who are currently receiving mental healthcare in Montefiore's Outpatient Psychiatry Department, rather than those on the waitlist to receive these services. All six participants will then complete a post-intervention qualitative interview to inform potential changes to intervention procedures. During this second phase, suicide recovery narratives will be provided, in audio and text formats, via a smartphone app. That same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, as well as secondary and additional outcomes, five times per day. The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial. During Phase 3, participants will be recruited to a control condition (n=15) and a treatment condition (n=30). Those in the Phase 3 treatment condition will receive the same intervention (1 SWEEP narrative per day for 14 days + 3x/day EMA) as those in Phase 2. Those in the Control condition will receive 3x/day EMA only.
A recent amendment approved by the IRB decreased the maximum response time for follow-up after participants report an adverse event from 24 hours to 12 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)This is a single-arm study. All participants will be allocated to the intervention arm, in which they will receive the digital narrative therapy. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- past-month history of suicidal thoughts
- past-month history of Major depressive disorder
- possession of apple or android smartphone with data plan
Key exclusion criteria (4 listed)
- inability to read/write in English
- Active mania
- Active psychosis
- Autism spectrum disorder
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 |
|---|---|---|
| Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)Also: SWEEPEach day during a 14-day trial period, participants will receive one narrative featuring lived experience with and recovery from suicidal thoughts and behaviors. These narratives will be presented in audio and text format via a smartphone app. Participants will also complete self-report surveys assessing study outcomes using the same smartphone app five times per day. | Behavioural | Intervention |
Primary outcome
Suicidal Thoughts
Time frame: 5 times per day during 14-day trial
Participants will self-report their current subjective intensity of suicidal thoughts using an 11-point Likert-type scale, with higher scores indicating more intense suicidal thoughts.
5 secondary outcomes
Suicidal Urge Resistance
Time frame: 5 times per day during 14-day trial
Social Connectedness
Time frame: 5 times per day during 14-day trial
Optimism
Time frame: 5 times per day during 14-day trial
Social Support
Time frame: 5 times per day during 14-day trial
Intervention Acceptability
Time frame: Study conclusion (at the end of the 14-day trial)
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 5 Oct 2026.
- Background: PubMed 36066864Franz PJ, Mou D, Kessler DT, Stubbing J, Jaroszewski AC, Ray S, Cao-Silveira VB, Bachman S, Schuster S, Graupensperger D, Alpert JE, Porath M, Nock MK. Digital bibliotherapy as a scalable intervention for suicidal thoughts: A randomized controlled trial. J Consult Clin Psychol. 2022 Aug;90(8):626-637. doi: 10.1037/ccp0000752.
- BackgroundCenters for Disease Control and Prevention. 10 leading causes of death, United States. WISQARS Fatal Injury Data Visualization Tool.
- Background: PubMed 33119344Fox KR, Huang X, Guzman EM, Funsch KM, Cha CB, Ribeiro JD, Franklin JC. Interventions for suicide and self-injury: A meta-analysis of randomized controlled trials across nearly 50 years of research. Psychol Bull. 2020 Dec;146(12):1117-1145. doi: 10.1037/bul0000305. Epub 2020 Oct 29.
- Background: PubMed 35599542Alvarez K, Polanco-Roman L, Samuel Breslow A, Molock S. Structural Racism and Suicide Prevention for Ethnoracially Minoritized Youth: A Conceptual Framework and Illustration Across Systems. Am J Psychiatry. 2022 Jun;179(6):422-433. doi: 10.1176/appi.ajp.21101001.
- Background: PubMed 33325985Bray MJC, Daneshvari NO, Radhakrishnan I, Cubbage J, Eagle M, Southall P, Nestadt PS. Racial Differences in Statewide Suicide Mortality Trends in Maryland During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Psychiatry. 2021 Apr 1;78(4):444-447. doi: 10.1001/jamapsychiatry.2020.3938.
- Background: PubMed 5319266Weimerskirch PJ. Benjamin Rush and John Minson Galt, II. Pioneers of bibliotherapy in America. Bull Med Libr Assoc. 1965 Oct;53(4):510-26.
- Background: PubMed 33364987Stip E, Ostlundh L, Abdel Aziz K. Bibliotherapy: Reading OVID During COVID. Front Psychiatry. 2020 Dec 7;11:567539. doi: 10.3389/fpsyt.2020.567539. eCollection 2020.
- Background: PubMed 10077290Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25. doi: 10.1017/s003329179800765x.
- Background: PubMed 28993103Gualano MR, Bert F, Martorana M, Voglino G, Andriolo V, Thomas R, Gramaglia C, Zeppegno P, Siliquini R. The long-term effects of bibliotherapy in depression treatment: Systematic review of randomized clinical trials. Clin Psychol Rev. 2017 Dec;58:49-58. doi: 10.1016/j.cpr.2017.09.006. Epub 2017 Sep 29.
- Background: PubMed 29954043Bietti LM, Tilston O, Bangerter A. Storytelling as Adaptive Collective Sensemaking. Top Cogn Sci. 2019 Oct;11(4):710-732. doi: 10.1111/tops.12358. Epub 2018 Jun 28.
- Background: PubMed 31046432Rennick-Egglestone S, Morgan K, Llewellyn-Beardsley J, Ramsay A, McGranahan R, Gillard S, Hui A, Ng F, Schneider J, Booth S, Pinfold V, Davidson L, Franklin D, Bradstreet S, Arbour S, Slade M. Mental Health Recovery Narratives and Their Impact on Recipients: Systematic Review and Narrative Synthesis. Can J Psychiatry. 2019 Oct;64(10):669-679. doi: 10.1177/0706743719846108. Epub 2019 May 2.
- Background: PubMed 20438238Van Orden KA, Witte TK, Cukrowicz KC, Braithwaite SR, Selby EA, Joiner TE Jr. The interpersonal theory of suicide. Psychol Rev. 2010 Apr;117(2):575-600. doi: 10.1037/a0018697.
- Individual participant dataSharing planned: Undecided. The research team will consider requests to share specific data with qualified research teams 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.
Peter J Franz, Ph.D. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Wellbeing with Everyday Experiences of Peers (SWEEP) in people with Suicide, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 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: looking for participants now, as of the sponsor's last update on 5 Oct 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Peter J Franz, Ph.D. (6077278620, peter.franz@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Thoughts (time frame: 5 times per day during 14-day trial). 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 NCT06349915, which also lists 18 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 5 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.