Depression MildHERMESNCT04318236
Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression
A study testing HERMES (Online Self-Help Intervention based on problem-solving therapy) in people with Depression Mild and Depression Moderate, run by University of Bern at 1 site in Switzerland.
Trial summary
A vast amount of studies show that online interventions are suitable to reduce symptoms of mental illness as for instance depression or anxiety. However, participants who use online interventions are more likely to drop out of treatment compared to face-to-face interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- HERMES (Online Self-Help Intervention based on problem-solving therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Mar 2020to 1 Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9-Score between 5 - 14
- Signed Informed Consent
- Contact information provided in case of emergency
- Internet connection and device to use it (Smartphone, Computer, Tablet)
- Fluent in german language
Who cannot join
- Suicidal tendencies (SBQ-R > 7)
- a current or previous diagnose of a bipolar or psychotic disorder
- a current diagnosis of severe depression or another psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms
A vast amount of studies show that online interventions are suitable to reduce symptoms of mental illness as for instance depression or anxiety. However, participants who use online interventions are more likely to drop out of treatment compared to face-to-face interventions. It is important to enhance adherence to online interventions so that participants engage longer in the programs. Also, as online interventions are useful to reduce the burden of mental illness, it is of interest to further improve outcomes of such interventions. Therefore, it will be investigated in this study whether or not four different factors have an impact in fostering adherence to and improving outcome of an internet-based self-help intervention based on problem-solving therapy. A multifactorial design will be used for this study to screen simultaneously whether or not i) a diagnostic telephone interview and, ii) an educational module based on motivational interviewing prior to the intervention and iii) guidance by the study team, and iv) automated e-mail reminders during the study are active factors in enhancing adherence to and outcome of online interventions.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- HERMES (Online Self-Help Intervention based on problem-solving therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERMES (Online Self-Help Intervention based on problem-solving therapy)Behavioural
Also called diagnostic telephone interview (yes/no) (prior to the access to HERMES), motivational module (yes/no) (prior to the access to HERMES), guidance (yes/no) (during the usage of HERMES), e-mail reminders (yes/no) (during the usage of HERMES)
The Online Self-Help Intervention is an online program based on the problem-solving therapy (an evidence based approach of psychotherapy). All participants will receive the exact same intervention.
However, what will be experimentally varied are the four listed interventions.
| Study group | Role | What they receive |
|---|---|---|
| Online-Program + factors 1,2,3,4 | Experimental | In this "arm" all four factors are set to "active" (i.e. yes):
* diagnostic interview
* motivational module
* guidance
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,2,3 | Experimental | In this "arm" three factors are set to "active" (i.e. yes):
* diagnostic interview
* motivational module
* guidance Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,2,4 | Experimental | In this "arm" three factors are set to "active" (i.e. yes):
* diagnostic interview
* motivational module
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,2 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* diagnostic interview
* motivational module Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,3,4 | Experimental | In this "arm" three factors are set to "active" (i.e. yes):
* diagnostic interview
* guidance
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,3 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* diagnostic interview
* guidance Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 1,4 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* diagnostic interview
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factor 1 | Experimental | In this "arm" one factor is set to "active" (i.e. yes):
- diagnostic interview Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 2,3,4 | Experimental | In this "arm" three factors are set to "active" (i.e. yes):
* motivational module
* guidance
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 2,3 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* motivational module
* guidance Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 2,4 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* motivational module
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factor 2 | Experimental | In this "arm" one factor is set to "active" (i.e. yes):
- motivational module Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factors 3,4 | Experimental | In this "arm" two factors are set to "active" (i.e. yes):
* guidance
* e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factor 3 | Experimental | In this "arm" one factor is set to "active" (i.e. yes):
- guidance Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + factor 4 | Experimental | In this "arm" one factor is set to "active" (i.e. yes):
- e-mail reminders Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
| Online-Program + no factor | Experimental | In this "arm" no factor is set to "active" (i.e. yes): Receives: Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Measured: Baseline
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Measured: 2 weeks
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Measured: 4 weeks
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Measured: 10 weeks
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Measured: 16 weeks
Secondary outcomes (11)
Adherence to Intervention (1)
Assessed with the online Program. Indicator of adherence: time spent in program
Measured: through study completion, an average of 16 weeks
Adherence to Intervention (2)
Assessed with the online Program. Indicator of adherence: clicks
Measured: through study completion, an average of 16 weeks
Adherence to Intervention (3)
Assessed with the online Program. Indicator of adherence: number of exercises completed
Measured: through study completion, an average of 16 weeks
Anxiety Symptoms
Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
Measured: Baseline, 10 weeks, 16 weeks
Stress Symptoms
Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
Measured: Baseline, 10 weeks, 16 weeks
Health
Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
Measured: Baseline, 10 weeks, 16 weeks
Suicidal Tendency
Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
Measured: Baseline, 10 weeks, 16 weeks
Social Problem Solving
Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
Measured: Baseline, 10 weeks, 16 weeks
Satisfaction with treatment
Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson \& Zwick, 1982)
Measured: 10 weeks
Negative Effects of Psychotherapy
Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, \& Nestoriuc, 2014)
Measured: 10 weeks, 16 weeks
Usability of Intervention
Assessed with System Usability Scale (SAS; Brooke, 1996)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start3 Mar 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Berger, Prof. Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318236
- Sponsor's protocol ID
- KEK BE 2019-01795
- Acronym
- HERMES
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available, after all planned analysis have been made by the Investigators.
Publications
Bur OT, Berger T. Participant Adherence and Contact Behavior in a Guided Internet Intervention for Depressive Symptoms: Exploratory Study. JMIR Form Res. 2024 Dec 16;8:e46860. doi: 10.2196/46860.
PubMed 39679951Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: A randomized full factorial trial. Behav Res Ther. 2022 May;152:104070. doi: 10.1016/j.brat.2022.104070. Epub 2022 Mar 6.
PubMed 35306266Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e21207. doi: 10.2196/21207.
PubMed 33528377
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04318236
- Acronym / sponsor ID
- HERMES / KEK BE 2019-01795
- Conditions
- Depression Mild, Depression Moderate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 23 Mar 2020 (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.
A vast amount of studies show that online interventions are suitable to reduce symptoms of mental illness as for instance depression or anxiety. However, participants who use online interventions are more likely to drop out of treatment compared to face-to-face interventions. It is important to enhance adherence to online interventions so that participants engage longer in the programs. Also, as online interventions are useful to reduce the burden of mental illness, it is of interest to further improve outcomes of such interventions. Therefore, it will be investigated in this study whether or not four different factors have an impact in fostering adherence to and improving outcome of an internet-based self-help intervention based on problem-solving therapy. A multifactorial design will be used for this study to screen simultaneously whether or not i) a diagnostic telephone interview and, ii) an educational module based on motivational interviewing prior to the intervention and iii) guidance by the study team, and iv) automated e-mail reminders during the study are active factors in enhancing adherence to and outcome of online interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- Model description
- Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
| Arm | Type | Receives |
|---|---|---|
| Online-Program + factors 1,2,3,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" all four factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance * e-mail reminders |
| Online-Program + factors 1,2,3 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance |
| Online-Program + factors 1,2,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * e-mail reminders |
| Online-Program + factors 1,2 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * motivational module |
| Online-Program + factors 1,3,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * guidance * e-mail reminders |
| Online-Program + factors 1,3 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * guidance |
| Online-Program + factors 1,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * e-mail reminders |
| Online-Program + factor 1 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" one factor is set to "active" (i.e. yes): - diagnostic interview |
| Online-Program + factors 2,3,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" three factors are set to "active" (i.e. yes): * motivational module * guidance * e-mail reminders |
| Online-Program + factors 2,3 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * motivational module * guidance |
| Online-Program + factors 2,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * motivational module * e-mail reminders |
| Online-Program + factor 2 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" one factor is set to "active" (i.e. yes): - motivational module |
| Online-Program + factors 3,4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" two factors are set to "active" (i.e. yes): * guidance * e-mail reminders |
| Online-Program + factor 3 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" one factor is set to "active" (i.e. yes): - guidance |
| Online-Program + factor 4 | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" one factor is set to "active" (i.e. yes): - e-mail reminders |
| Online-Program + no factor | Experimental | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)In this "arm" no factor is set to "active" (i.e. yes): |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PHQ-9-Score between 5 - 14
- Signed Informed Consent
- Contact information provided in case of emergency
- Internet connection and device to use it (Smartphone, Computer, Tablet)
- Fluent in german language
Key exclusion criteria (3 listed)
- Suicidal tendencies (SBQ-R > 7)
- a current or previous diagnose of a bipolar or psychotic disorder
- a current diagnosis of severe depression or another psychological 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 |
|---|---|---|
| HERMES (Online Self-Help Intervention based on problem-solving therapy)Also: diagnostic telephone interview (yes/no) (prior to the access to HERMES), motivational module (yes/no) (prior to the access to HERMES), guidance (yes/no) (during the usage of HERMES), e-mail reminders (yes/no) (during the usage of HERMES)The Online Self-Help Intervention is an online program based on the problem-solving therapy (an evidence based approach of psychotherapy). All participants will receive the exact same intervention. However, what will be experimentally varied are the four listed interventions. | Behavioural | Online-Program + factor 1, Online-Program + factor 2, Online-Program + factor 3, Online-Program + factor 4, Online-Program + factors 1,2, Online-Program + factors 1,2,3, Online-Program + factors 1,2,3,4, Online-Program + factors 1,2,4, Online-Program + factors 1,3, Online-Program + factors 1,3,4, Online-Program + factors 1,4, Online-Program + factors 2,3, Online-Program + factors 2,3,4, Online-Program + factors 2,4, Online-Program + factors 3,4, Online-Program + no factor |
Primary outcome
Change in Depressive Symptoms
Time frame: Baseline
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
Time frame: 2 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
Time frame: 4 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
Time frame: 10 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
Time frame: 16 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
11 secondary outcomes
Adherence to Intervention (1)
Time frame: through study completion, an average of 16 weeks
Adherence to Intervention (2)
Time frame: through study completion, an average of 16 weeks
Adherence to Intervention (3)
Time frame: through study completion, an average of 16 weeks
Anxiety Symptoms
Time frame: Baseline, 10 weeks, 16 weeks
Stress Symptoms
Time frame: Baseline, 10 weeks, 16 weeks
Health
Time frame: Baseline, 10 weeks, 16 weeks
Suicidal Tendency
Time frame: Baseline, 10 weeks, 16 weeks
Social Problem Solving
Time frame: Baseline, 10 weeks, 16 weeks
Satisfaction with treatment
Time frame: 10 weeks
Negative Effects of Psychotherapy
Time frame: 10 weeks, 16 weeks
Usability of Intervention
Time frame: 10 weeks
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 3 May 2021.
- Derived from this study: PubMed 39679951Bur OT, Berger T. Participant Adherence and Contact Behavior in a Guided Internet Intervention for Depressive Symptoms: Exploratory Study. JMIR Form Res. 2024 Dec 16;8:e46860. doi: 10.2196/46860.
- Derived from this study: PubMed 35306266Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: A randomized full factorial trial. Behav Res Ther. 2022 May;152:104070. doi: 10.1016/j.brat.2022.104070. Epub 2022 Mar 6.
- Derived from this study: PubMed 33528377Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e21207. doi: 10.2196/21207.
- Homepage of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available, after all planned analysis have been made by the Investigators.
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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.
Thomas Berger, Prof. Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HERMES (Online Self-Help Intervention based on problem-solving therapy) in people with Depression Mild and Depression Moderate, run by University of Bern 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 5 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: finished, as of the sponsor's last update on 3 May 2021. 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?
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?
Change in Depressive Symptoms (time frame: Baseline). The study lists 5 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 NCT04318236, which also lists 3 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 3 May 2021.