Specific PhobiaNCT04563390
Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia.
A study testing Projection-based augmented reality exposure therapy (P-ARET). and In vivo exposure therapy in people with Specific Phobia, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The main aim of this study is to validate and test the clinical effectiveness of the projection-based augmented reality system in cockroach phobia exposure therapy through an RCT that includes three conditions: (i) projection-based augmented reality therapy, (ii) usual treatment (in vivo exposure), (iii) waiting list… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Projection-based augmented reality exposure therapy (P-ARET). and In vivo exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 31 Jul 2026
- 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
- Being at least 18 years old
- Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches
- Having a minimum of six-month duration of the phobia
- Sign an informed consent
- Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied
Who cannot join
- Presence of another severe mental disorder that requires immediate attention
- Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
- Currently being treated in a similar treatment program
- Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
- Receiving other psychological treatment during the study for cockroach phobia
- Start receiving pharmacological treatment during the study (or in case of being already taking them, change the drug or dose)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Jaume I
Castellon, Castellón, 12071
Soledad Quero, Psychology, 964387641 ext. +34, squero@uji.es
Juana María Bretón-López, Psychology
About this study
Official title: Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia. A Randomized Controlled Trial
The main aim of this study is to validate and test the clinical effectiveness of the projection-based augmented reality system in cockroach phobia exposure therapy through an RCT that includes three conditions: (i) projection-based augmented reality therapy, (ii) usual treatment (in vivo exposure), (iii) waiting list control. In addition, it is intended to analyze the potential of the eye-tracking technology as a tool for evaluating the clinical effectiveness in cockroach phobia treatment.
Read the detailed description
The measurement of attentional biases as a clinical evaluation tool in anxiety disorders is presented as a valuable instrument capable of evaluating changes in the automatic cognitive processes that are involved in their maintenance. However, the variability between the different methodologies used for its measurement has produced a lack of empirical consistency that supports the use of this tool with a clinical purpose. The appearance and implementation of eye tracking technology in experimental studies has made it possible to overcome this problem. Despite this, to our knowledge, there are still no studies that implement this technology in the clinical field as a tool for evaluating therapeutic effectiveness.
Specific phobia is the anxiety disorder with the highest prevalence and, specifically the animal subtype, is one of the most prevalent (3.8%), producing a significant interference and high comorbidity. Despite that in vivo exposure therapy is the treatment of choice for specific phobia, the high dropout rates and difficulties in its application pose major limitations for its therapeutic implementation. The emergence of technologies such as augmented reality (AR) has made it possible to overcome these barriers, offering new ways of applying exposure therapy. AR technology offers the capacity to interact with the stimulus in the real world, facilitating the therapeutic process and the generalization of its results. Some studies have tested the effectivity and efficacy of the AR technology in small animals exposure treatment revealing promising results. However, these studies used a version of AR that requires the use of a device placed on the participant's head (HDM-Head Mounted Display) which can cause dizziness and back pain in some participants and limits the therapist-patient communication. An improved version of the AR system based on projection helps to solve this problem, allowing a more natural interaction with the stimulus and the therapist and greater comfort. The preliminary efficacy of this system has been tested in a case study but, so far, there is no RCT evaluating the efficacy of this AR system. Therefore, in this work two objectives are pursued, firstly, to test and validate a projection-based AR system in the phobia of cockroaches treatment and, secondly, to evaluate the clinical potential of the eye-tracking technology as a specific measure to assess changes in cognitive processes.
The Randomized Clinical Trial (RCT) will be conducted following the Consolidated Standards of Reporting Trials (CONSORT: http://www.consort-statement.org) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Participants (N=96) will be randomized into three groups (after receiving a SP diagnosis - DSM-5): 1) Projection-based augmented reality therapy (P-ARET); 2) In vivo Exposure therapy (IVET); and 3) a waiting list control group (WL). Participants in the WL will be randomly assigned to one of the two treatment conditions after spending time on the waiting list (1 week) for ethical reasons. Outcome measures will be assessed at baseline, post-treatment and 1-, 6-, and 12-month follow-ups.
- Conditions
- Specific Phobia
- Being tested
- Projection-based augmented reality exposure therapy (P-ARET)., In vivo exposure therapy
- Keywords
- Specific phobia, Cockroach phobia, Exposure therapy, In vivo exposure, Projection-Based augmented reality therapy, Randomized Controlled Trial
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Projection-based augmented reality exposure therapy (P-ARET).Behavioural
The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.
In vivo exposure therapyBehavioural
The intervention will be based on traditional in vivo exposure therapy to real cockroaches. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Projection-based augmented reality exposure therapy | Experimental | Intervention group that receives the projection-based augmented reality to carry out the exposure therapy for cockroach phobia. Receives: Behavioral: Projection-based augmented reality exposure therapy (P-ARET). |
| In vivo exposure | Experimental | Intervention group that receives traditional in vivo exposure therapy for cockroach phobia. Receives: Behavioral: In vivo exposure therapy |
| WL Control | No intervention | Waiting list control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated on a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).
Measured: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Secondary outcomes (5)
Change in attentional biases
An eye-tracking attentional task has been specifically designed for this project. This task evaluates the attentional bias toward cockroaches in terms of time, gaze direction and visual scanning pattern and can reveal changes in attentional bias after the treatment compared to the start
Measured: Baseline and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months)
Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
This questionnaire assesses the level of fear to cockroaches. It has 18 items evaluated in a scale ranging from 1 (nothing) to 7 (very much).
Measured: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).
This questionnaire assesses two different constructs, namely catastrophic beliefs about cockroaches and beliefs about the patient's own ability to cope with a cockroach. It has 48 items evaluated in a scale ranging from 0 (I don´t believe so) to 100 (I´m convinced of it).
Measured: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).
This instrument assesses the level of fear and avoidance to the feared stimulus (i. e., cockroaches), ranged from 0 (nothing) to 10 (very much). It evaluates target behavior, negative thoughts and modulators.
Measured: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).
This instrument evaluates the degree of improvement of the patient' symptoms after the treatment compared to the start. It is ranged from 1 (much worse) and 7 (much better).
Measured: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies 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
- Randomized Controlled Trial with two treatment conditions and one WL control condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soledad Quero, Psychology, Principal investigator, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563390
- Sponsor's protocol ID
- TERA-P EY CP
- Status last verified
- May 2024
- First submitted
- 16 Sep 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Authors declare that due to ethical and legal reasons according to the preservation of the privacy of the participants the data from the clinical trial will be available upon reasonable request.
Publications
Wrzesien, M., Botella, C., Bretón-López, J., del Río González, E., Burkhardt, J. M., Alcañiz, M., & Pérez-Ara, M. Á. (2015). Treating small animal phobias using a projective-augmented reality system: A single-case study. Computers in Human Behavior, 49, 343-353.
Tobon, J. I., Ouimet, A. J., & Dozois, D. J. (2011). Attentional bias in anxiety disorders following cognitive behavioral treatment. Journal of Cognitive Psychotherapy, 25(2), 114-129.
Botella C, Perez-Ara MA, Breton-Lopez J, Quero S, Garcia-Palacios A, Banos RM. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial. PLoS One. 2016 Feb 17;11(2):e0148237. doi: 10.1371/journal.pone.0148237. eCollection 2016.
PubMed 26886423Thorpe SJ, Salkovskis PM. The effect of one-session treatment for spider phobia on attentional bias and beliefs. Br J Clin Psychol. 1997 May;36(2):225-41. doi: 10.1111/j.2044-8260.1997.tb01409.x.
PubMed 9167863Grimaldos J, Breton-Lopez J, Palau-Batet M, Diaz-Sanahuja L, Quero S. Effectiveness of a projection-based augmented reality exposure system in treating cockroach phobia: study protocol of a randomised controlled trial. BMJ Open. 2023 May 19;13(5):e069025. doi: 10.1136/bmjopen-2022-069025.
PubMed 37208132
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04563390
- Acronym / sponsor ID
- TERA-P EY CP
- Conditions
- Specific Phobia
- Keywords
- Specific phobia, Cockroach phobia, Exposure therapy, In vivo exposure, Projection-Based augmented reality therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Sep 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.
The main aim of this study is to validate and test the clinical effectiveness of the projection-based augmented reality system in cockroach phobia exposure therapy through an RCT that includes three conditions: (i) projection-based augmented reality therapy, (ii) usual treatment (in vivo exposure), (iii) waiting list control. In addition, it is intended to analyze the potential of the eye-tracking technology as a tool for evaluating the clinical effectiveness in cockroach phobia treatment.
Detailed description
The measurement of attentional biases as a clinical evaluation tool in anxiety disorders is presented as a valuable instrument capable of evaluating changes in the automatic cognitive processes that are involved in their maintenance. However, the variability between the different methodologies used for its measurement has produced a lack of empirical consistency that supports the use of this tool with a clinical purpose. The appearance and implementation of eye tracking technology in experimental studies has made it possible to overcome this problem. Despite this, to our knowledge, there are still no studies that implement this technology in the clinical field as a tool for evaluating therapeutic effectiveness.
Specific phobia is the anxiety disorder with the highest prevalence and, specifically the animal subtype, is one of the most prevalent (3.8%), producing a significant interference and high comorbidity. Despite that in vivo exposure therapy is the treatment of choice for specific phobia, the high dropout rates and difficulties in its application pose major limitations for its therapeutic implementation. The emergence of technologies such as augmented reality (AR) has made it possible to overcome these barriers, offering new ways of applying exposure therapy. AR technology offers the capacity to interact with the stimulus in the real world, facilitating the therapeutic process and the generalization of its results. Some studies have tested the effectivity and efficacy of the AR technology in small animals exposure treatment revealing promising results. However, these studies used a version of AR that requires the use of a device placed on the participant's head (HDM-Head Mounted Display) which can cause dizziness and back pain in some participants and limits the therapist-patient communication. An improved version of the AR system based on projection helps to solve this problem, allowing a more natural interaction with the stimulus and the therapist and greater comfort. The preliminary efficacy of this system has been tested in a case study but, so far, there is no RCT evaluating the efficacy of this AR system. Therefore, in this work two objectives are pursued, firstly, to test and validate a projection-based AR system in the phobia of cockroaches treatment and, secondly, to evaluate the clinical potential of the eye-tracking technology as a specific measure to assess changes in cognitive processes.
The Randomized Clinical Trial (RCT) will be conducted following the Consolidated Standards of Reporting Trials (CONSORT: http://www.consort-statement.org) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Participants (N=96) will be randomized into three groups (after receiving a SP diagnosis - DSM-5): 1) Projection-based augmented reality therapy (P-ARET); 2) In vivo Exposure therapy (IVET); and 3) a waiting list control group (WL). Participants in the WL will be randomly assigned to one of the two treatment conditions after spending time on the waiting list (1 week) for ethical reasons. Outcome measures will be assessed at baseline, post-treatment and 1-, 6-, and 12-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial with two treatment conditions and one WL control condition.
| Arm | Type | Receives |
|---|---|---|
| Projection-based augmented reality exposure therapy | Experimental | Behavioral: Projection-based augmented reality exposure therapy (P-ARET).Intervention group that receives the projection-based augmented reality to carry out the exposure therapy for cockroach phobia. |
| In vivo exposure | Experimental | Behavioral: In vivo exposure therapyIntervention group that receives traditional in vivo exposure therapy for cockroach phobia. |
| WL Control | No intervention | –Waiting list control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being at least 18 years old
- Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches
- Having a minimum of six-month duration of the phobia
- Sign an informed consent
- Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied
Key exclusion criteria (6 listed)
- Presence of another severe mental disorder that requires immediate attention
- Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
- Currently being treated in a similar treatment program
- Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
- Receiving other psychological treatment during the study for cockroach phobia
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 |
|---|---|---|
| Projection-based augmented reality exposure therapy (P-ARET).The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention. | Behavioural | Projection-based augmented reality exposure therapy |
| In vivo exposure therapyThe intervention will be based on traditional in vivo exposure therapy to real cockroaches. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention. | Behavioural | In vivo exposure |
Primary outcome
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated on a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).
5 secondary outcomes
Change in attentional biases
Time frame: Baseline and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months)
Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
Time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).
Time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).
Time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).
Time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- BackgroundWrzesien, M., Botella, C., Bretón-López, J., del Río González, E., Burkhardt, J. M., Alcañiz, M., & Pérez-Ara, M. Á. (2015). Treating small animal phobias using a projective-augmented reality system: A single-case study. Computers in Human Behavior, 49, 343-353.
- BackgroundTobon, J. I., Ouimet, A. J., & Dozois, D. J. (2011). Attentional bias in anxiety disorders following cognitive behavioral treatment. Journal of Cognitive Psychotherapy, 25(2), 114-129.
- Results publication: PubMed 26886423Botella C, Perez-Ara MA, Breton-Lopez J, Quero S, Garcia-Palacios A, Banos RM. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial. PLoS One. 2016 Feb 17;11(2):e0148237. doi: 10.1371/journal.pone.0148237. eCollection 2016.
- Results publication: PubMed 9167863Thorpe SJ, Salkovskis PM. The effect of one-session treatment for spider phobia on attentional bias and beliefs. Br J Clin Psychol. 1997 May;36(2):225-41. doi: 10.1111/j.2044-8260.1997.tb01409.x.
- Derived from this study: PubMed 37208132Grimaldos J, Breton-Lopez J, Palau-Batet M, Diaz-Sanahuja L, Quero S. Effectiveness of a projection-based augmented reality exposure system in treating cockroach phobia: study protocol of a randomised controlled trial. BMJ Open. 2023 May 19;13(5):e069025. doi: 10.1136/bmjopen-2022-069025.
- Individual participant dataSharing planned: Yes. Authors declare that due to ethical and legal reasons according to the preservation of the privacy of the participants the data from the clinical trial will be available upon reasonable 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.
Soledad Quero, Psychology principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Projection-based augmented reality exposure therapy (P-ARET). and In vivo exposure therapy in people with Specific Phobia, run by Universitat Jaume I at 1 site in Spain.
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 6 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: status not confirmed, as of the sponsor's last update on 17 May 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soledad Quero, Psychology (96 438 76 41 ext. +34, squero@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991) (time frame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).). 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 NCT04563390, which also lists 5 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 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.