AggressionLGB-TNBNCT07212283
Wise Intervention for Reducing Aggressive Behaviors and Promoting Prosocial Behaviors Toward LGB-TNB Individuals
A study testing Wise Intervention LGB-TNB and Values alignment wise intervention in people with Aggression and Adolescence, run by University of Deusto at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of a wise Intervention to reduce aggressive behaviors and promote prosocial behaviors toward LGB-TNB individuals among Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression, Adolescence
- What is being tested?
- Wise Intervention LGB-TNB and Values alignment wise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2025to 14 Jun 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Informed consent by the adolescents and their families.
- To be fluent in Spanish and/or Euskera.
Who cannot join
- Lack of permission by families and the adolescent.
- Lack of understanding of the instructions.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of a wise Intervention to reduce aggressive behaviors and promote prosocial behaviors toward LGB-TNB individuals among Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.
Read the detailed description
Discrimination based on sexual orientation and gender identity is a social problem of great relevance. Sexual orientation is understood as the mechanism that directs affective-sexual attraction and interest, manifesting with varying intensity. Regarding gender identity, it has historically been interpreted under a binary paradigm based on external sexual organs, rendering trans and non-binary identities invisible. However, it is currently understood as the internal feeling about one's own gender, so that trans and/or non-binary people represent those whose gender identity differs from the one assigned at birth.
Despite the growing visibility, public awareness, and recognition of the rights of lesbian, gay, bisexual, trans, and non-binary people (LGB-TNB), discrimination based on sexual orientation and gender identity continues to be a social problem of great relevance with serious consequences for those who suffer it. This reality underlines the need to implement effective interventions aimed at addressing these aggressive behaviors and the mechanisms that sustain them, not only among those who perpetrate acts of violence, but also among people who witness these aggressive behaviors.
In addition, intervening during adolescence is especially relevant, as this stage represents a critical moment in the moral, social, and emotional development of individuals. Moreover, during adolescence, discriminatory behaviors and peer aggression increase, and previous studies show that LGB-TNB people face a higher risk of violence in educational settings. Nevertheless, although adolescence becomes a critical period for the development of risk behaviors, it also involves important transitions and learning opportunities. Furthermore, adolescence is a turning point during which well-designed interventions have a high potential to redirect a person's developmental trajectory in a lasting way. Therefore, it can be an especially favorable moment for implementing interventions.
In this way, numerous interventions have been carried out in educational settings to prevent aggressive behaviors among peers. Although most of these initiatives have mainly focused on more general problems, such as bullying and cyberbullying, in recent years preventive interventions specifically aimed at reducing aggressive behaviors based on sexual orientation and gender identity in both face-to-face and digital contexts have increased. However, most current interventions focus on educating people about issues related to LGB-TNB topics, reaching mixed and contradictory results regarding their effectiveness, and also highlighting that there is little empirical evidence about the robustness of the effects of LGB-TNB interventions and their underlying mechanisms. Therefore, these interventions present areas for improvement that constitute important challenges for scientific psychology.
Recently, interest has grown in social psychology regarding a new approach to interventions, which have been called wise interventions. Many of these interventions have impactful results because they are usually very brief in time and produce lasting changes in people's behavior. Moreover, this type of intervention is of great interest in adolescence, as they allow themselves to be designed in such a way that they are perceived as respectful of students' autonomy and status, so that they feel they are making their own decisions.
Therefore, the aim of this project is to adapt to the LGB-TNB context a wise intervention to reduce online and offline aggression among adolescents, especially based on sexual orientation and gender identity, and to increase the intention to support and prosocial behaviors when participants witness these aggressions, especially those directed at LGB-TNB people.
- Conditions
- Aggression, Adolescence
- Being tested
- Wise Intervention LGB-TNB, Values alignment wise intervention
- Keywords
- Adolescence, LGBTQ, Aggression, Prosocial Behavior, Wise Intervention
- Medical subject headings
- Aggression, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wise Intervention LGB-TNBBehavioural
The intervention will be designed to reduce aggressive behaviors based on sexual orientation and gender identity and to promote prosocial behaviors toward these individuals. This intervention will include three components: (1) reading scientific studies about people's ability to change. In addition, they will read other studies about how thoughts and emotions influence behavior through brain pathways, and that these pathways can be modified under certain circumstances; (2) reading testimonials that support the idea that people can change. These testimonials include accounts of people who were victims or perpetrators based on sexual orientation and gender identity, including important components of empathy and prosocial behaviors toward the victims. To give credibility to the intervention, they will be informed that these stories were written by other young people who previously participated; and (3) self-persuasion exercises that involve an active commitment to change.
Values alignment wise interventionBehavioural
This intervention will be based on the same strategies as the experimental intervention, but it will not address aspects related to prosocial behaviors or aggression toward LGB-TNB individuals; instead, it will be applied to improve adolescents' eating habits.
| Study group | Role | What they receive |
|---|---|---|
| Values alignment wise intervention | Active comparator | Not described Receives: Behavioral: Values alignment wise intervention |
| Wise Intervention LGB-TNB | Experimental | Not described Receives: Behavioral: Wise Intervention LGB-TNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in aggression scores toward LGB-TNB individuals, assessed using an adaptation of the Spanish version (Orue et al., 2018) of the Homophobic Bullying Scale (Prati, 2012).
It consists of seven items that ask frequency with wich participants have engaged in specific aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in online aggression scores toward LGB-TNB individuals, assessed using the Technology-Facilitated Gender- and Sexuality-Based violence (TFGSV; Martínez-Bacaicoa et al., 2023).
It consists of eight items that ask frequency with wich participants have engaged in online aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in prosocial behavior scores toward LGB-TNB individuals through an ad hoc measure.
It consists of one item in which participants were asked to select all the behaviors they engaged in after witnessing an aggression.
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in bystander intention scores when witnessing aggressive behavior toward LGB-TNB individuals.
This measure evaluate bystander intentions in response to LGB-TNB aggressions, through different scenarios. After reading the scenarios, participants answered five items that evaluated possible courses of action to take in response to the aggression.
Measured: Assessments were conducted at baseline, immediately after the intervention, and at 3, 6, and 9 months.
Secondary outcomes (8)
Change from baseline in moral disengagement scores, assessed using the mechanisms of moral disengagement described by Bandura (2016) and based on studies with similar characteristics (Martínez-Bacaicoa et al., 2024).
It consists of eight items representing the eight mechanisms that allow participants to morally disengage. Five response categories are provided using a Likert-type response scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in justice sensitivity scores, assessed using the Justice Sensitivity Inventory (Schmitt et al., 2010).
It consists of 10 items that assess sensitivity to unjust situations. Five response categories are provided using a Likert-type response scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in behaviors supporting LGB-TNB individuals, assessed using the LGBT-Affirming Behavior questionnaire (Poteat, 2015).
It consists of five items that assess supportive behaviors toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (0 times) to 5 (7 or more times).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in microaggression scores toward LGB-TNB individuals, assessed using the Sexual Orientation Microaggression Scale (SOMS-P; Botor & Tuliao, 2025) and the Gender Identity Microaggression Scale (GIMS-P; Botor & Tuliao, 2025).
A total of 25 items are used to assess microaggressions toward LGB-TNB individuals. Specifically, 20 items assess microaggressions toward LGB individuals and 5 items assess microaggressions toward TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (almost every week).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in offline perpetration scores, assessed using the Spanish adaptation (Ortega-Ruiz et al., 2016) of the European Bullying Intervention Project Questionnaire (Brighi et al., 2012).
It consists of six items that ask about the frequency with which participants have engaged in aggressive behaviors in offline contexts. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (almost every week).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in online perpetration scores, assessed using an adaptation of the Cyberbullying Questionnaire items (Calvete et al., 2010; Gámez-Guadix et al., 2014).
It consists of five items that ask about the frequency with which participants have engaged in aggressive behaviors in online contexts. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (almost every week).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in healthy and unhealthy food intake scores, assessed using an adaptation of the KIDMED 2.0 questionnaire, validated in a sample of Spanish children and adolescents (López-Gajardo et al., 2022).
It consists of 16 items that ask about the frequency of healthy and unhealthy food intake. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).
Measured: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in alignment of healthy eating habits scores, as assessed by the questionnaire developed by Bryan et al. (2019).
It consists of seven items that assess the alignment between participants' healthy eating habits and their personal values. Five response categories are provided using a Likert-type response scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Assessments were conducted at baseline, immediately after the intervention, and at 3, 6, and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start18 Sep 2025
- Primary completion14 Jun 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two groups will be used. Randomization will be done by clusters, using the classroom as the unit. First, the schools will be selected according to their characteristics. Then, half of the participants will be assigned to the experimental intervention (condition 1) and the other half to the control intervention (condition 2) in parallel for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nerea Cortazar Enciondo, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212283
- Sponsor's protocol ID
- ETK-90/24-25
- Acronym
- LGB-TNB
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available at OSF when the results of the study are published.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wise Intervention for Reducing Aggressive Behaviors and Promoting Prosocial Behaviors Toward LGB-TNB Individuals
- ClinicalTrials.gov ID
- NCT07212283
- Acronym / sponsor ID
- LGB-TNB / ETK-90/24-25
- Conditions
- Aggression, Adolescence
- Keywords
- Adolescence, LGBTQ, Aggression, Prosocial Behavior, Wise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of a wise Intervention to reduce aggressive behaviors and promote prosocial behaviors toward LGB-TNB individuals among Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.
Detailed description
Discrimination based on sexual orientation and gender identity is a social problem of great relevance. Sexual orientation is understood as the mechanism that directs affective-sexual attraction and interest, manifesting with varying intensity. Regarding gender identity, it has historically been interpreted under a binary paradigm based on external sexual organs, rendering trans and non-binary identities invisible. However, it is currently understood as the internal feeling about one's own gender, so that trans and/or non-binary people represent those whose gender identity differs from the one assigned at birth.
Despite the growing visibility, public awareness, and recognition of the rights of lesbian, gay, bisexual, trans, and non-binary people (LGB-TNB), discrimination based on sexual orientation and gender identity continues to be a social problem of great relevance with serious consequences for those who suffer it. This reality underlines the need to implement effective interventions aimed at addressing these aggressive behaviors and the mechanisms that sustain them, not only among those who perpetrate acts of violence, but also among people who witness these aggressive behaviors.
In addition, intervening during adolescence is especially relevant, as this stage represents a critical moment in the moral, social, and emotional development of individuals. Moreover, during adolescence, discriminatory behaviors and peer aggression increase, and previous studies show that LGB-TNB people face a higher risk of violence in educational settings. Nevertheless, although adolescence becomes a critical period for the development of risk behaviors, it also involves important transitions and learning opportunities. Furthermore, adolescence is a turning point during which well-designed interventions have a high potential to redirect a person's developmental trajectory in a lasting way. Therefore, it can be an especially favorable moment for implementing interventions.
In this way, numerous interventions have been carried out in educational settings to prevent aggressive behaviors among peers. Although most of these initiatives have mainly focused on more general problems, such as bullying and cyberbullying, in recent years preventive interventions specifically aimed at reducing aggressive behaviors based on sexual orientation and gender identity in both face-to-face and digital contexts have increased. However, most current interventions focus on educating people about issues related to LGB-TNB topics, reaching mixed and contradictory results regarding their effectiveness, and also highlighting that there is little empirical evidence about the robustness of the effects of LGB-TNB interventions and their underlying mechanisms. Therefore, these interventions present areas for improvement that constitute important challenges for scientific psychology.
Recently, interest has grown in social psychology regarding a new approach to interventions, which have been called wise interventions. Many of these interventions have impactful results because they are usually very brief in time and produce lasting changes in people's behavior. Moreover, this type of intervention is of great interest in adolescence, as they allow themselves to be designed in such a way that they are perceived as respectful of students' autonomy and status, so that they feel they are making their own decisions.
Therefore, the aim of this project is to adapt to the LGB-TNB context a wise intervention to reduce online and offline aggression among adolescents, especially based on sexual orientation and gender identity, and to increase the intention to support and prosocial behaviors when participants witness these aggressions, especially those directed at LGB-TNB people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two groups will be used. Randomization will be done by clusters, using the classroom as the unit. First, the schools will be selected according to their characteristics. Then, half of the participants will be assigned to the experimental intervention (condition 1) and the other half to the control intervention (condition 2) in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Values alignment wise intervention | Active comparator | Behavioral: Values alignment wise intervention |
| Wise Intervention LGB-TNB | Experimental | Behavioral: Wise Intervention LGB-TNB |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Informed consent by the adolescents and their families.
- To be fluent in Spanish and/or Euskera.
Key exclusion criteria (2 listed)
- Lack of permission by families and the adolescent.
- Lack of understanding of the instructions.
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 |
|---|---|---|
| Wise Intervention LGB-TNBThe intervention will be designed to reduce aggressive behaviors based on sexual orientation and gender identity and to promote prosocial behaviors toward these individuals. This intervention will include three components: (1) reading scientific studies about people's ability to change. In addition, they will read other studies about how thoughts and emotions influence behavior through brain pathways, and that these pathways can be modified under certain circumstances; (2) reading testimonials that support the idea that people can change. These testimonials include accounts of people who were victims or perpetrators based on sexual orientation and gender identity, including important components of empathy and prosocial behaviors toward the victims. To give credibility to the intervention, they will be informed that these stories were written by other young people who previously participated; and (3) self-persuasion exercises that involve an active commitment to change. | Behavioural | Wise Intervention LGB-TNB |
| Values alignment wise interventionThis intervention will be based on the same strategies as the experimental intervention, but it will not address aspects related to prosocial behaviors or aggression toward LGB-TNB individuals; instead, it will be applied to improve adolescents' eating habits. | Behavioural | Values alignment wise intervention |
Primary outcome
Change from baseline in aggression scores toward LGB-TNB individuals, assessed using an adaptation of the Spanish version (Orue et al., 2018) of the Homophobic Bullying Scale (Prati, 2012).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
It consists of seven items that ask frequency with wich participants have engaged in specific aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).
Change from baseline in online aggression scores toward LGB-TNB individuals, assessed using the Technology-Facilitated Gender- and Sexuality-Based violence (TFGSV; Martínez-Bacaicoa et al., 2023).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
It consists of eight items that ask frequency with wich participants have engaged in online aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).
Change from baseline in prosocial behavior scores toward LGB-TNB individuals through an ad hoc measure.
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
It consists of one item in which participants were asked to select all the behaviors they engaged in after witnessing an aggression.
Change from baseline in bystander intention scores when witnessing aggressive behavior toward LGB-TNB individuals.
Time frame: Assessments were conducted at baseline, immediately after the intervention, and at 3, 6, and 9 months.
This measure evaluate bystander intentions in response to LGB-TNB aggressions, through different scenarios. After reading the scenarios, participants answered five items that evaluated possible courses of action to take in response to the aggression.
8 secondary outcomes
Change from baseline in moral disengagement scores, assessed using the mechanisms of moral disengagement described by Bandura (2016) and based on studies with similar characteristics (Martínez-Bacaicoa et al., 2024).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in justice sensitivity scores, assessed using the Justice Sensitivity Inventory (Schmitt et al., 2010).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in behaviors supporting LGB-TNB individuals, assessed using the LGBT-Affirming Behavior questionnaire (Poteat, 2015).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in microaggression scores toward LGB-TNB individuals, assessed using the Sexual Orientation Microaggression Scale (SOMS-P; Botor & Tuliao, 2025) and the Gender Identity Microaggression Scale (GIMS-P; Botor & Tuliao, 2025).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in offline perpetration scores, assessed using the Spanish adaptation (Ortega-Ruiz et al., 2016) of the European Bullying Intervention Project Questionnaire (Brighi et al., 2012).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in online perpetration scores, assessed using an adaptation of the Cyberbullying Questionnaire items (Calvete et al., 2010; Gámez-Guadix et al., 2014).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in healthy and unhealthy food intake scores, assessed using an adaptation of the KIDMED 2.0 questionnaire, validated in a sample of Spanish children and adolescents (López-Gajardo et al., 2022).
Time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.
Change from baseline in alignment of healthy eating habits scores, as assessed by the questionnaire developed by Bryan et al. (2019).
Time frame: Assessments were conducted at baseline, immediately after the intervention, and at 3, 6, and 9 months.
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 1 Oct 2026.
- Individual participant dataSharing planned: Yes. Raw data will be available at OSF when the results of the study are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wise Intervention LGB-TNB and Values alignment wise intervention in people with Aggression and Adolescence, run by University of Deusto 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 2 inclusion and 2 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 1 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 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?
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 from baseline in aggression scores toward LGB-TNB individuals, assessed using an adaptation of the Spanish version (Orue et al., 2018) of the Homophobic Bullying Scale (Prati, 2012). (time frame: Assessments were conducted at baseline and at 3, 6, and 9 months.). The study lists 4 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 1 Oct 2026.