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?

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.

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+