ViraSafe App for Suicidal Ideation

(ViraSafeRCT Trial)

SS
Overseen ByStephanie Stepp, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Ksana Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called ViraSafe, designed to assist young people who have considered or attempted suicide. The goal is to determine if this app enhances their use of coping skills and safety planning compared to an earlier app, BRITE. The trial seeks young participants who have recently attempted suicide or experienced serious suicidal thoughts and are currently receiving care. Participants must speak and read English and have regular access to a smartphone.

As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions and potentially benefit from new supportive technologies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

What prior data suggests that the ViraSafe app is safe for use in adolescents?

Research has shown that digital tools, like apps, can help manage suicidal thoughts. The ViraSafe app is an improved version of the BRITE app, which clinical trials have tested. These trials found that the BRITE app effectively helps people manage suicidal thoughts by providing strategies to deal with triggers and urges.

Although specific safety data for ViraSafe is not yet available, the successful testing of the BRITE app suggests that similar digital tools are generally safe. ViraSafe aims to enhance user engagement and coping skills based on this foundation. Generally, mental health support apps are well-received and don't usually cause negative effects since they don't involve surgery or physical procedures. This history suggests that ViraSafe is likely to be well-tolerated.1234

Why are researchers excited about this trial?

Researchers are excited about ViraSafe because it's an innovative app that combines the proven BRITE coping skills with new safety planning features, all within the Vira behavior change platform. Unlike traditional approaches that might focus solely on therapy or medication, ViraSafe offers a digital, interactive tool that empowers users to manage suicidal thoughts proactively. This unique integration provides users with personalized strategies in real-time, potentially transforming how individuals cope with suicidal ideation by making support more accessible and tailored to their needs.

What evidence suggests that the ViraSafe app is effective for improving engagement with coping skills and safety planning among suicidal adolescents?

Research has shown that digital tools like apps can lower the risk of suicide by facilitating the use of safety plans and coping skills. One study found that a mobile phone app providing therapy specifically for suicide prevention reduced suicidal behavior in high-risk patients. In this trial, participants will use either the ViraSafe app, an improved version of the BRITE app, or the original BRITE app. Clinical trials have tested the BRITE app, which helps users manage suicidal thoughts. ViraSafe aims to increase user involvement and enhance the effectiveness of safety planning. Although specific data on ViraSafe is limited, its improvements draw from successful methods used in similar apps.56789

Are You a Good Fit for This Trial?

This trial is for young people aged 13-24 who have attempted suicide in the past year and had suicidal thoughts recently. They must speak English, be able to read, and have a parent or guardian if under 18. Participants need to be getting care at certain clinics with trained staff for using ViraSafe or BRITE apps.

Inclusion Criteria

I can speak and read English fluently.
I have attempted suicide in the past year and had suicidal thoughts in the last month.
I am receiving care at a clinic that uses the ViraSafe or BRITE safety plan.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Baseline Assessment

Participants complete a baseline assessment virtually over video conference or phone call

1 week
1 visit (virtual)

Treatment

Participants are randomized to receive either the ViraSafe or BRITE app and complete safety planning with a clinician

3 months
Ongoing virtual interactions

Follow-up

Participants are monitored for engagement and changes in mental health indicators

3 months
2 visits (virtual) at 1-month and 3-month timepoints

What Are the Treatments Tested in This Trial?

Interventions

  • ViraSafe

Trial Overview

The study tests an app called ViraSafe against the original BRITE app. Both are digital tools designed to help suicidal adolescents engage with coping skills and safety planning. The trial lasts three months and aims to see which app improves engagement better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ViraSafeExperimental Treatment1 Intervention
Group II: BRITEActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ksana Health

Lead Sponsor

Trials
3
Recruited
290+

University of Pittsburgh Medical Center

Collaborator

Trials
78
Recruited
77,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

A Just-in-time Adaptive Intervention for Suicide Safety ...

This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning ...

Effectiveness of Mobile Applications for Suicide Prevention

This meta-analysis aimed to evaluate the effectiveness of mobile applications designed to reduce suicide risk, focusing on studies published ...

Yale Study: Mobile Phone App Reduced Suicidal Behavior ...

A mobile phone app designed to deliver suicide-specific therapy reduced suicidal behavior among high-risk psychiatric inpatients, ...

Efficacy of internet-based interventions to reduce suicidal ...

Limited data on suicide attempts precluded robust analysis of this outcome. Conclusion. Internet-based interventions show inconsistent effects ...

Efficacy of BrighterSide, a Self-Guided App for Suicidal Ideation

Results: Suicidal ideation reduced over time for all participants, but there was no significant interaction between group and time. Similar ...

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caparentyouthhelpline.org

caparentyouthhelpline.org/

California Parent & Youth Helpline: Home

Asking for Help is a Sign of Strength® A new study in the Journal of Technology in Human Services found that: 85% of callers to the Helpline feel more ...

Mobile apps designed to help prevent suicide - APA Services

Our panel of psychologists share their ratings and reviews of apps to help patients who are experiencing suicidal ideation: Virtual Hope Box, Suicide Safe, and ...

Impact of Digital Safety Plan Activation on Subsequent ...

Individuals with suicidal behaviors often seek help in emergency departments (ED), making mental health providers critical to suicide prevention ...

A Just-in-time Adaptive Intervention for Suicide Safety ...

Each app involves a trained clinician from their clinic setting collaboratively completing a safety plan. If a mental health clinician is not ...