Suicidal Ideation and BehaviorNCT06759129
RomSi: Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy
A study testing Immediate-use of a mobile health application until completion and Delayed use of a mobile health application until completion in people with Suicidal Ideation and Behavior and Suicide, run by University of Valencia at 1 site in Spain.
Trial summary
Suicide is one of the leading causes of death in Spain, representing a public health crisis that requires urgent and effective solutions. The stigma surrounding suicide prevents many at-risk individuals from seeking help, worsening the problem. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation and Behavior, Suicide
- What is being tested?
- Immediate-use of a mobile health application until completion and Delayed use of a mobile health application until completion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2025to Jan 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years old or older.
- Have a cell phone with internet access during the intervention and follow-up periods.
- Be able to speak, understand, and read in Spanish.
Who cannot join
- Presence of high suicidal ideation (measured during screening, with a score above 20 on the total SIDAS scale or between 7 and 10 on the item assessing suicide attempts).
- Presence of high social desirability bias (measured during screening, with a score of 14 or higher on the MC-SDS scale).
- Altered mental status that impedes the ability to provide informed consent or assent (e.g., acute psychosis, intoxication, or mania).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia
Adriana Mira Pastor, PhD, +34 963 86 41 00, adriana.mira@uv.es
Rosa María Baños, Professor
About this study
Official title: RomSi (Rompiendo el Silencio) Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy: Protocol for a Cross-Over Randomized Controlled Trial
Suicide is one of the leading causes of death in Spain, representing a public health crisis that requires urgent and effective solutions. The stigma surrounding suicide prevents many at-risk individuals from seeking help, worsening the problem. Addressing this stigma is essential to implement more effective and accessible prevention strategies. This study aims to design and evaluate an innovative mobile health intervention to reduce stigma and encourage help-seeking behaviours in the general population. While the intervention targets the general population, two specific groups will access specialized and tailored content: individuals with low suicidal ideation and family members or close friends of people who have died by suicide. A daily assessment will collect real-time data and evaluate the intervention's impact. The study will employ a randomised controlled trial (RCT) with a crossover design, with participants randomly assigned to immediate or delayed use conditions. The intervention's effectiveness and usability will be assessed at four key points through quantitative analyses and qualitative interviews. We hypothesise that the intervention will improve suicide literacy, reduce suicide-related stigma, increase help-seeking behaviours, and demonstrate high usability and acceptability.
Read the detailed description
Despite advances in suicide prevention research, implementation faces significant challenges. One major obstacle is stigma, which discourages many at-risk individuals from seeking help and hinders public awareness and societal commitment to addressing this issue openly and responsibly.
Public stigma includes negative beliefs, such as perceiving individuals with suicidal thoughts as "weak" or "selfish." This stigma can be internalized by those experiencing suicidal ideation or behaviour, negatively affecting their self-esteem and increasing their distress and isolation due to fear of rejection. Furthermore, family members and friends who have lost a loved one to suicide also face stigma, complicating their grieving process and increasing their risk of depression.
This context highlights the need for effective interventions to reduce stigma, encourage help-seeking, and provide support for both at-risk individuals and their loved ones.
The goal of this study is to develop and validate a mobile application called RomSi ("Rompiendo el silencio" in Spanish; Breaking the Silence), designed to improve knowledge about suicide, reduce associated stigma, and promote help-seeking behaviours. The app incorporates four intervention approaches that have proven effective in other mental health stigma reduction programs:
- Psychoeducation,
- Interpersonal contact,
- Cognitive flexibility, and
- Values-based work.
Additionally, the app will leverage innovative tools like a daily assessment to collect real-time data. Gamification elements will also be used to enhance motivation and engagement throughout the intervention.
To evaluate the effectiveness of RomSi, a randomized controlled trial (RCT) with a crossover design will be conducted. Participants will be randomly assigned to one of two groups:
- iApp: Immediate use of the app.
- dApp: Delayed use (waitlist control).
The randomization process will use a computer-generated sequence, concealed from researchers until group assignment, and stratified based on stigma levels toward suicide.
Evaluations will occur at five key time points:
- T0 (pre-intervention): Initial questionnaires.
- T1 (post-intervention): After app completion (iApp) or after 10 days of waiting (dApp).
- T2: Follow-up 10 days after T1.
- T3: Follow-up 1 month.
- T4: Follow-up 3 months.
The iApp group will begin using the app immediately after T0 and will have 10 days to complete it, though they may proceed at their own pace. The dApp group will act as a waitlist control, starting the app after completing T1 and following the same evaluation schedule.
During the intervention, a daily assessment will be used to measure stigma levels, as well as suicidal ideation and help-seeking intentions.
- Conditions
- Suicidal Ideation and Behavior, Suicide
- Being tested
- Immediate-use of a mobile health application until completion, Delayed use of a mobile health application until completion
- Keywords
- Suicide Prevention, Stigma, Suicide Literacy, Help Seeking, Randomized Controlled Trial
- Medical subject headings
- Suicidal Ideation, Behavior, Suicide, Suicide Prevention, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate-use of a mobile health application until completionBehavioural
Also called iApp
Participants will use the RomSi app for approximately 10 days, completing all scheduled activities. Throughout the intervention, they will respond to a daily assessment designed to evaluate stigma, help-seeking intentions, and suicidal ideation.
The activities within the app will include interactive games aimed at fostering empathy and emotional understanding. Participants will also have continuous access to specialized help contacts to ensure their well-being during the study.
The protocol involves two groups that will receive tailored information based on their specific needs:
- Individuals with low suicidal ideation and/or self-stigma, who will engage in activities focused on reducing personal stigma.
- Individuals experiencing suicide bereavement, who will receive support tailored to address their loss and foster resilience.
A follow-up will be carried out one month and three months after the end of the intervention.
Delayed use of a mobile health application until completionBehavioural
Also called dApp
Participants assigned to the dApp group (delayed use) will not have access to the RomSi app during the first 10 days of the study.
After completing this initial control phase, participants in the dAPP group will begin using the RomSi app, following the same protocol as the iAPP group. This includes interactive activities, such as games designed to foster empathy and understanding, along with continuous access to specialized help contacts. A daily assessment will collect real-time data and evaluate the intervention's impact.
This crossover design allows for the immediate effects of the intervention to be compared between groups, while also evaluating changes in pre- and post-intervention measures across both conditions.
A follow-up will be carried out one month and three months after the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-use | Experimental | Participants will use the mobile application starting immediately after the baseline assessment (T0) for approximately 10 days or until they complete the app. Receives: Behavioral: Immediate-use of a mobile health application until completion |
| Delayed use | Active comparator | Participants will start using the application 10 days after the baseline assessment (T0) and immediately after the T1 assessment. Receives: Behavioral: Delayed use of a mobile health application until completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide public stigma
Public stigma will be assessed using the Spanish version of the Stigma of Suicide Scale - Short Form (SOSS-SF). This scale includes 16 adjectives that prototypically describe a person who has died by suicide. It is designed for use with the general population and identifies three distinct factors: (1) Stigma (e.g., pathetic), (2) glorification/Normalization (e.g., brave), and (3) isolation/Depression (e.g., lonely). Each item is rated on a 5-point Likert scale, where higher scores indicate stronger agreement with the adjective as a representation of a prototypical suicidal person.
Measured: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
Suicide literacy
The Literacy of Suicide Scale - Short Form (LOSS-SF) will be used to assess levels of suicide-related knowledge. The Spanish validation comprises 10 items divided into four domains: (1) signs and symptoms, (2) causes or nature, (3) risk factors, and (4) treatment and prevention. Responses are provided on a three-point scale ("true," "false," "don't know"). Each correct response is awarded one point, with higher scores indicating greater literacy about suicide.
Measured: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
Intention to seek help
The General Help-Seeking Questionnaire (GHSQ) measures the intention to seek help from various sources. Participants rate 10 items regarding their likelihood of seeking help on a 7-point scale ranging from 1 (extremely unlikely) to 7 (extremely likely) for 10 different help sources. The questionnaire provides an overall score and two subscale scores: formal help sources and informal help sources, with higher scores indicating greater help-seeking intention.
Measured: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
Daily assessment questionnaire protocol
Participants will be assessed daily using a brief self-report assessment to evaluate public stigma toward suicide, suicidal ideation, and help-seeking intention. Public stigma will be measured using words derived from the literature. Help-seeking intention will be assessed with a specific item, while suicidal ideation will be evaluated using the Spanish version of the Suicidal Ideation Attributes Scale (SIDAS).
Measured: Public stigma will be assessed daily during the 10-day intervention period. Help-seeking intention and suicidal ideation will be assessed at three specific time points throughout the intervention.
Secondary outcomes (3)
Personal suicide stigma
The Personal Suicide Stigma Questionnaire (PSSQ) will be used to assess individuals' perceptions of social responses to their experiences with suicidal behaviour. It comprises 16 items rated on a 5-point Likert scale (1 = never to 5 = very often) and includes three subscales: Rejection, Minimization, and Self-Blame. The total score ranges from 16 to 80, with higher scores indicating greater experiences of suicide-related stigma.
Measured: This measure will only be implemented for participants with low or moderate suicidal ideation. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at the end of the control phase f
Suicide grief experience
The Grief Experience Questionnaire (GEQ) will be used to assess feelings arising from the experience of suicide among individuals close to the deceased. The scale consists of 55 items that measure the frequency of specific reactions experienced during the two years following the loss, rated on a 5-point Likert scale (1 = never to 5 = almost always). The items are distributed across 11 subscales.
Measured: This measure will only be implemented for participants who indicate bereavement as a consequence of suicide in the screening. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at
Stigma by association towards suicide.
The Stigma of Suicide and Suicide Survivor Scale (STOSASS) will be used to assess perceived stigma toward suicide and suicide survivors. The tool consists of two subscales: one for stigma toward suicide and another for stigma toward survivors, each comprising 13 items rated on a 4-point scale (1 to 4). The total score is calculated as the average of the 13-item scores, with higher total scores indicating greater perceived stigma.
Measured: Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal Ideation and BehaviorStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759129
- Sponsor's protocol ID
- VH9FA3L6BJ015JSE
- Status last verified
- May 2026
- First submitted
- 10 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pierantonelli M, Mira A, Escriva-Martinez T, Diego-Pedro R, Desdentado L, Banos RM. Breaking the silence: Randomized controlled trial protocol of a mobile application to reduce suicide stigma, improve literacy, and promote help-seeking. Contemp Clin Trials. 2026 Nov 2:108523. doi: 10.1016/j.cct.2026.108523. Online ahead of print.
PubMed 42971396
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RomSi (Rompiendo el Silencio) Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy: Protocol for a Cross-Over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06759129
- Acronym / sponsor ID
- VH9FA3L6BJ015JSE
- Conditions
- Suicidal Ideation and Behavior, Suicide
- Keywords
- Suicide Prevention, Stigma, Suicide Literacy, Help Seeking, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Jan 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.
Suicide is one of the leading causes of death in Spain, representing a public health crisis that requires urgent and effective solutions. The stigma surrounding suicide prevents many at-risk individuals from seeking help, worsening the problem. Addressing this stigma is essential to implement more effective and accessible prevention strategies. This study aims to design and evaluate an innovative mobile health intervention to reduce stigma and encourage help-seeking behaviours in the general population. While the intervention targets the general population, two specific groups will access specialized and tailored content: individuals with low suicidal ideation and family members or close friends of people who have died by suicide. A daily assessment will collect real-time data and evaluate the intervention's impact. The study will employ a randomised controlled trial (RCT) with a crossover design, with participants randomly assigned to immediate or delayed use conditions. The intervention's effectiveness and usability will be assessed at four key points through quantitative analyses and qualitative interviews. We hypothesise that the intervention will improve suicide literacy, reduce suicide-related stigma, increase help-seeking behaviours, and demonstrate high usability and acceptability.
Detailed description
Despite advances in suicide prevention research, implementation faces significant challenges. One major obstacle is stigma, which discourages many at-risk individuals from seeking help and hinders public awareness and societal commitment to addressing this issue openly and responsibly.
Public stigma includes negative beliefs, such as perceiving individuals with suicidal thoughts as "weak" or "selfish." This stigma can be internalized by those experiencing suicidal ideation or behaviour, negatively affecting their self-esteem and increasing their distress and isolation due to fear of rejection. Furthermore, family members and friends who have lost a loved one to suicide also face stigma, complicating their grieving process and increasing their risk of depression.
This context highlights the need for effective interventions to reduce stigma, encourage help-seeking, and provide support for both at-risk individuals and their loved ones.
The goal of this study is to develop and validate a mobile application called RomSi ("Rompiendo el silencio" in Spanish; Breaking the Silence), designed to improve knowledge about suicide, reduce associated stigma, and promote help-seeking behaviours. The app incorporates four intervention approaches that have proven effective in other mental health stigma reduction programs:
- Psychoeducation,
- Interpersonal contact,
- Cognitive flexibility, and
- Values-based work.
Additionally, the app will leverage innovative tools like a daily assessment to collect real-time data. Gamification elements will also be used to enhance motivation and engagement throughout the intervention.
To evaluate the effectiveness of RomSi, a randomized controlled trial (RCT) with a crossover design will be conducted. Participants will be randomly assigned to one of two groups:
- iApp: Immediate use of the app.
- dApp: Delayed use (waitlist control).
The randomization process will use a computer-generated sequence, concealed from researchers until group assignment, and stratified based on stigma levels toward suicide.
Evaluations will occur at five key time points:
- T0 (pre-intervention): Initial questionnaires.
- T1 (post-intervention): After app completion (iApp) or after 10 days of waiting (dApp).
- T2: Follow-up 10 days after T1.
- T3: Follow-up 1 month.
- T4: Follow-up 3 months.
The iApp group will begin using the app immediately after T0 and will have 10 days to complete it, though they may proceed at their own pace. The dApp group will act as a waitlist control, starting the app after completing T1 and following the same evaluation schedule.
During the intervention, a daily assessment will be used to measure stigma levels, as well as suicidal ideation and help-seeking intentions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-use | Experimental | Behavioral: Immediate-use of a mobile health application until completionParticipants will use the mobile application starting immediately after the baseline assessment (T0) for approximately 10 days or until they complete the app. |
| Delayed use | Active comparator | Behavioral: Delayed use of a mobile health application until completionParticipants will start using the application 10 days after the baseline assessment (T0) and immediately after the T1 assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 18 years old or older.
- Have a cell phone with internet access during the intervention and follow-up periods.
- Be able to speak, understand, and read in Spanish.
Key exclusion criteria (3 listed)
- Presence of high suicidal ideation (measured during screening, with a score above 20 on the total SIDAS scale or between 7 and 10 on the item assessing suicide attempts).
- Presence of high social desirability bias (measured during screening, with a score of 14 or higher on the MC-SDS scale).
- Altered mental status that impedes the ability to provide informed consent or assent (e.g., acute psychosis, intoxication, or mania).
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 |
|---|---|---|
| Immediate-use of a mobile health application until completionAlso: iAppParticipants will use the RomSi app for approximately 10 days, completing all scheduled activities. Throughout the intervention, they will respond to a daily assessment designed to evaluate stigma, help-seeking intentions, and suicidal ideation. The activities within the app will include interactive games aimed at fostering empathy and emotional understanding. Participants will also have continuous access to specialized help contacts to ensure their well-being during the study. The protocol involves two groups that will receive tailored information based on their specific needs: 1. Individuals with low suicidal ideation and/or self-stigma, who will engage in activities focused on reducing personal stigma. 2. Individuals experiencing suicide bereavement, who will receive support tailored to address their loss and foster resilience. A follow-up will be carried out one month and three months after the end of the intervention. | Behavioural | Immediate-use |
| Delayed use of a mobile health application until completionAlso: dAppParticipants assigned to the dApp group (delayed use) will not have access to the RomSi app during the first 10 days of the study. After completing this initial control phase, participants in the dAPP group will begin using the RomSi app, following the same protocol as the iAPP group. This includes interactive activities, such as games designed to foster empathy and understanding, along with continuous access to specialized help contacts. A daily assessment will collect real-time data and evaluate the intervention's impact. This crossover design allows for the immediate effects of the intervention to be compared between groups, while also evaluating changes in pre- and post-intervention measures across both conditions. A follow-up will be carried out one month and three months after the end of the intervention. | Behavioural | Delayed use |
Primary outcome
Suicide public stigma
Time frame: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
Public stigma will be assessed using the Spanish version of the Stigma of Suicide Scale - Short Form (SOSS-SF). This scale includes 16 adjectives that prototypically describe a person who has died by suicide. It is designed for use with the general population and identifies three distinct factors: (1) Stigma (e.g., pathetic), (2) glorification/Normalization (e.g., brave), and (3) isolation/Depression (e.g., lonely). Each item is rated on a 5-point Likert scale, where higher scores indicate stronger agreement with the adjective as a representation of a prototypical suicidal person.
Suicide literacy
Time frame: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
The Literacy of Suicide Scale - Short Form (LOSS-SF) will be used to assess levels of suicide-related knowledge. The Spanish validation comprises 10 items divided into four domains: (1) signs and symptoms, (2) causes or nature, (3) risk factors, and (4) treatment and prevention. Responses are provided on a three-point scale ("true," "false," "don't know"). Each correct response is awarded one point, with higher scores indicating greater literacy about suicide.
Intention to seek help
Time frame: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
The General Help-Seeking Questionnaire (GHSQ) measures the intention to seek help from various sources. Participants rate 10 items regarding their likelihood of seeking help on a 7-point scale ranging from 1 (extremely unlikely) to 7 (extremely likely) for 10 different help sources. The questionnaire provides an overall score and two subscale scores: formal help sources and informal help sources, with higher scores indicating greater help-seeking intention.
Daily assessment questionnaire protocol
Time frame: Public stigma will be assessed daily during the 10-day intervention period. Help-seeking intention and suicidal ideation will be assessed at three specific time points throughout the intervention.
Participants will be assessed daily using a brief self-report assessment to evaluate public stigma toward suicide, suicidal ideation, and help-seeking intention. Public stigma will be measured using words derived from the literature. Help-seeking intention will be assessed with a specific item, while suicidal ideation will be evaluated using the Spanish version of the Suicidal Ideation Attributes Scale (SIDAS).
3 secondary outcomes
Personal suicide stigma
Time frame: This measure will only be implemented for participants with low or moderate suicidal ideation. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at the end of the control phase f
Suicide grief experience
Time frame: This measure will only be implemented for participants who indicate bereavement as a consequence of suicide in the screening. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at
Stigma by association towards suicide.
Time frame: Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
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 12 May 2026.
- Derived from this study: PubMed 42971396Pierantonelli M, Mira A, Escriva-Martinez T, Diego-Pedro R, Desdentado L, Banos RM. Breaking the silence: Randomized controlled trial protocol of a mobile application to reduce suicide stigma, improve literacy, and promote help-seeking. Contemp Clin Trials. 2026 Nov 2:108523. doi: 10.1016/j.cct.2026.108523. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate-use of a mobile health application until completion and Delayed use of a mobile health application until completion in people with Suicidal Ideation and Behavior and Suicide, run by University of Valencia 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 3 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: looking for participants now, as of the sponsor's last update on 12 May 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?
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 Adriana Mira Pastor, PhD (+34963 86 41 00, adriana.mira@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide public stigma (time frame: Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.). 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?
On the ClinicalTrials.gov record for NCT06759129, which also lists 1 linked publication.
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 12 May 2026.