Digital Platform for Youth Suicide Prevention

Overseen By Randy Auerbach, PhD, ABPP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ksana Health

Disqualifiers: Higher care level, Assigned clinician

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital platform called Vira to help prevent suicide among youth. The goal is to determine if Vira, which tracks sleep patterns and mood via smartphone, can enhance the usual therapy process. Participants will use the Vira app alongside their regular treatment to assess its effectiveness in managing mental health risks. This trial suits teens who own a smartphone, speak English, and are already in an intensive therapy program. As an unphased trial, it offers participants a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a digital platform for youth suicide prevention, so it's best to ask the trial coordinators for more details.

What prior data suggests that this digital platform is safe for youth?

Research has shown that the Vira app is generally easy to use. Participants in studies found the app user-friendly. The app uses phone sensors to track activity and sleep and sends reminders to help users change their habits. No major reports of serious side effects have emerged from using the app. It primarily helps users monitor their behaviors and moods, making it a low-risk option for those concerned about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vira platform for youth suicide prevention because it integrates cutting-edge technology with mental health treatment. Unlike traditional methods, Vira utilizes a smartphone app that passively collects data from sensors, capturing insights into physical activity, sleep, mobility, and language patterns. This data provides a real-time, automated assessment of a user's mental state, allowing for timely interventions. Additionally, the app supports patients through just-in-time nudges that align with their behavior change plans and Dialectical Behavior Therapy (DBT). This innovative approach offers a personalized, proactive layer to conventional therapy, potentially transforming how we support at-risk youth.

What evidence suggests that the Vira platform is effective for youth suicide prevention?

Research has shown that the Vira platform, available to participants in this trial, could enhance mental health care for young people at risk of suicide. Studies have found that Vira increases patient engagement in their treatment and may lead to better health outcomes for these high-risk youth. The platform uses data from mobile phones to monitor behaviors such as activity and sleep, which relate to mental health. It also sends reminders to help users adhere to their treatment plans. Early results suggest that young people find Vira helpful and easy to use. ^{1 2 3 4 6}

Who Is on the Research Team?

Nick Allen, PhD

Principal Investigator

Ksana Health

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 13-18 who are at high risk for suicide and currently receiving treatment in the Intensive Adolescent and Family DBT Program. They must own a smartphone (Android or iPhone 7+) and have consent from guardians if under 18.

Inclusion Criteria

Owns a personal smartphone (Android or iPhone 7+)

I am a teenager who has given my written agreement, or I am 18 and have consented myself.

Fluent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive outpatient DBT supported by the Vira platform, which includes mobile sensing data collection and just-in-time nudges

6 months

Regular visits as part of the intensive outpatient program

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Vira

Trial Overview The study is testing 'Vira', a digital platform designed to help healthcare providers manage youth at risk of suicide by using mobile data and secure communication tools, compared with the usual treatment methods.

How Is the Trial Designed?

Group I: Digitally enhanced treatment supported by the Vira platform Experimental Treatment 1 Intervention

Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Intensive outpatient DBT + EARS app (passive data monitoring software)

Who Is Running the Clinical Trial?

Ksana Health

Lead Sponsor

Trials

3

Recruited

290+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The ibobbly mobile app, designed for Indigenous youth in remote Australia, significantly reduced symptoms of depression and psychological distress, as measured by the PHQ-9 and K10 scales, compared to a waitlist group.

While the app did not show significant reductions in suicidal ideation or impulsivity, it demonstrates potential as a feasible self-help tool for improving mental health in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibobbly mobile health intervention for suicide prevention in Australian Indigenous youth: a pilot randomised controlled trial. Tighe, J., Shand, F., Ridani, R., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A study involving eight adolescents and their parents highlighted the need for a mobile health (mHealth) application to support suicidal adolescents after hospitalization, particularly those who also consume alcohol.

Participants expressed a desire for the app to help them achieve alcohol- and mood-related goals, while parents wanted resources and guidance for discussing these issues with their children, indicating a strong demand for continued support post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An mHealth approach to extend a brief intervention for adolescent alcohol use and suicidal behavior: Qualitative analyses of adolescent and parent feedback. McManama O'Brien, KH., Battalen, AW., Sellers, CM., et al.[2020]

The study involving 20 adolescents discharged from a mental health ward showed that the smartphone apps BeyondNow and BlueIce were feasible and acceptable, with most participants accessing them at least once during the six-week follow-up.

While many participants found the apps easy to use, a significant portion (47%) felt they would not ensure safety during a crisis; however, improvements in suicide resilience were noted, indicating potential benefits in managing self-harm and suicidal behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps to manage self-harm and suicidal acts in adolescents admitted to an inpatient mental health ward. Muscara, F., Ng, O., Crossley, L., et al.[2022]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The I-CARE digital intervention significantly reduced emotional distress in adolescents with suicidality during their acute care hospital stay, with a notable decrease of 6.3 points on a 63-point scale (p = .02).

The intervention was highly rated for feasibility (97.5%), acceptability (90.0%), and appropriateness (77.5%) by participants, indicating it could effectively deliver psychosocial skills during critical periods before psychiatric hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I-CARE: Feasibility, Acceptability, and Appropriateness of a Digital Health Intervention for Youth Experiencing Mental Health Boarding. Leyenaar, JK., Arakelyan, M., Acquilano, SC., et al.[2023]

A pharmacovigilance analysis of over 85,000 cases from the FDA's Adverse Event Reporting System identified specific drug combinations and indications that may increase the risk of suicide, highlighting the complexity of suicide risk factors.

The study suggests that certain demographic groups may be more affected by these drug combinations, indicating a need for further research to validate these findings and improve suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. Ding, T., Chen, ES.[2020]

The study aims to implement an anti-stigma campaign and a mobile technology-based decision support system to reduce stigma, depression, and suicide risk among high-risk adolescents in urban slums in India, targeting around 250 million adolescents who are vulnerable to mental health issues.

This intervention will be evaluated through a cluster randomized control trial involving 30 slum clusters in Vijayawada and New Delhi, focusing on adolescents aged 10 to 19, with the goal of providing evidence-based strategies for improving mental health care in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to reduce stigma and improve management of depression, risk of suicide/self-harm and other significant emotional or medically unexplained complaints among adolescents living in urban slums: protocol for the ARTEMIS project. Yatirajula, SK., Kallakuri, S., Paslawar, S., et al.[2022]

The CALMA app, designed specifically for Spanish-speaking adolescents, aims to provide evidence-based tools from Dialectical Behavioral Therapy to help manage suicidal and self-injurious behaviors, addressing a significant gap in mental health resources for this demographic.

A randomized controlled trial will assess the app's effectiveness, safety, and user engagement among 58 participants aged 10 to 19 over 90 days, focusing on changes in self-injurious behaviors and emotional regulation, highlighting the potential of mobile technology in mental health interventions for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol. Rodante, DE., Chiapella, LC., Olivera Fedi, R., et al.[2023]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

A total of 524 reports of suicidal thoughts and behaviors were identified in children and adolescents treated with 10 different antidepressant drugs, indicating that adverse events can occur across various medications.

Fluoxetine and paroxetine showed notable peaks in reporting, with fluoxetine's peak linked to different reporting patterns compared to paroxetine, suggesting that consumer awareness and reporting may influence the perceived safety of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants. Mosholder, AD., Pamer, CA.[2006]

A cluster randomized controlled trial will evaluate an ICT-based program aimed at preventing suicide and improving mental health among 428 high-school students in Chile, marking the first clinical trial of its kind in Latin America.

The primary outcome of the study is to assess suicidal ideation at a 2-month follow-up, with secondary outcomes including measures of depression, anxiety, and stigma, highlighting the program's comprehensive approach to adolescent mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Information and Communication Technologies to Prevent Suicide Among Secondary School Students in Two Regions of Chile: A Randomized Controlled Trial. Mascayano, F., Schilling, S., Tapia, E., et al.[2020]

A study mapping online suicide support for young people found a variety of accessible resources, but highlighted a significant gap in services specifically tailored for young adults and students in crisis.

Qualitative feedback indicated that young people prefer clear, concise, and immediate text-based communication for seeking help, and while peer support can be valuable, it may also carry risks that need careful management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based support services to help prevent suicide in young people and students: A mixed-methods, user-informed review of characteristics and effective elements. Cohen, R., Rifkin-Zybutz, R., Moran, P., et al.[2023]

Qualitative interviews with clinicians, parents, and adolescents highlighted the importance of transition of care, specific treatment targets, and safety planning in preventing suicide reattempts among youth.

Participants unanimously supported the development of a smartphone application to aid in creating safety plans and improving treatment engagement for adolescents at risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report. Kennard, BD., Biernesser, C., Wolfe, KL., et al.[2022]

Out of 69 assessed depression and suicide prevention apps, only 5 (7%) included all six recommended suicide prevention strategies, highlighting a significant gap in adherence to evidence-based guidelines.

Several popular apps provided incorrect crisis helpline numbers, raising concerns about the safety and reliability of mental health resources available to users, particularly given that some apps had over a million downloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention and depression apps' suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines. Martinengo, L., Van Galen, L., Lum, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084771/

Acceptability and Usability of a Digital Behavioral Health ... All participants expressed that Vira could be useful in enhancing mental health treatment. Adolescents had positive feedback on the aesthetics ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05920252

A Digitally Assisted Risk Reduction Platform for Youth At ... The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes. Official Title.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40315450/

Acceptability and Usability of a Digital Behavioral Health ... Vira has a high potential to improve patient engagement and improve clinical outcomes among high-risk youth. Iterative UCD and ongoing ...

4. withpower.com withpower.com/trial/digital-platform-for-youth-suicide-prevention-9136d

Digital Platform for Youth Suicide Prevention Trial Overview The study is testing 'Vira', a digital platform designed to help healthcare providers manage youth at risk of suicide by using mobile data and ...

5. trialx.com trialx.com/clinical-trials/listings/287673/a-digitally-assisted-risk-reduction-platform-for-youth-at-high-risk-for-suicide/

A Digitally Assisted Risk Reduction Platform for Youth at ... This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a ...

6. ctv.veeva.com ctv.veeva.com/study/a-digitally-assisted-risk-reduction-platform-for-youth-at-high-risk-for-suicide

A Digitally Assisted Risk Reduction Platform for Youth At High ... The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, ...