Digital Therapeutic for Suicide Prevention

No longer recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Oui Therapeutics, Inc.

Disqualifiers: Untreated psychosis, Substance use, Cognitive impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new digital therapy, known as a digital therapeutic, can reduce suicide attempts. Researchers aim to determine if a special app, used alongside regular care, makes a difference. Participants are divided into two groups: one will use the app with usual treatment, while the other receives only the usual treatment. This trial targets individuals recently hospitalized who own a smartphone and are comfortable using apps. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital therapeutic is safe for suicide prevention?

Studies have shown that digital tools can help reduce suicidal thoughts and improve mental health. For example, a review of several studies found that these tools significantly improved suicidal thoughts. Another study found that these tools encourage people to seek help, increasing their likelihood of seeking support.

Regarding safety, digital treatments are generally well-tolerated because they typically involve apps or online resources, avoiding the risks associated with medications. Users of a self-guided safety planning app reported finding better ways to cope with issues related to suicide.

Since this trial is in its later stages, there is already some evidence of safety in humans. Digital treatments have been studied enough to advance to advanced testing, indicating they are generally considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for suicide prevention?

Researchers are excited about the digital therapeutic for suicide prevention because it uses a novel approach by integrating a mobile app with traditional care. Unlike standard treatments, which often rely on medication or in-person therapy sessions, this digital platform provides continuous support and personalized interventions directly on a user's smartphone. This accessibility and real-time engagement make it more adaptable to individual needs, potentially reducing barriers to care and offering timely help. Additionally, the app's ability to analyze user data and provide immediate feedback is a game-changer, offering a proactive approach to mental health management.

What evidence suggests that this digital therapeutic is effective for suicide prevention?

Research has shown that digital tools can help reduce suicide attempts. One study found that online cognitive behavior therapies (CBTs) focused on suicide reduced suicidal actions by about 20%. Another study discovered that a therapy app specifically for suicide lowered the rate of attempts by 14% for each module completed. Reviews of these digital tools also indicate they help decrease suicidal thoughts and encourage people to seek help. In this trial, participants will join either the Experimental App + Treatment as Usual group or the Other App + Treatment as Usual group. These findings suggest that digital therapies can effectively support people at risk of suicide. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've recently been hospitalized for suicide-related issues. Participants must understand the study, own a smartphone, and be willing to follow enrollment steps and provide contacts. It's not for those in other studies, with conditions affecting participation, untreated psychosis, substance impairment or cognitive issues.

Inclusion Criteria

Owns a smartphone

Patients recently hospitalized

Willing and able to complete enrollment procedures

Exclusion Criteria

Patients who upon clinical examination are cognitively impaired

I do not have any health issues that would stop me from completing the study.

Patients who have untreated psychosis or active psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital interventions and treatment as usual

104 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Therapeutic

Trial Overview The trial tests two digital interventions, OTX-202 and OTX-000, designed to reduce suicide attempts. The effectiveness of these digital tools will be evaluated among participants using their smartphones as part of the treatment process.

How Is the Trial Designed?

Group I: Other App + Treatment as Usual Experimental Treatment 2 Interventions

This intervention will be for the control group

Group II: Experimental App + Treatment as Usual Experimental Treatment 2 Interventions

This intervention will be for the treatment group

Who Is Running the Clinical Trial?

Oui Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

730+

Oui Therapeutics, LLC

Lead Sponsor

Trials

4

Recruited

400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Digital interventions, such as apps, showed a reduction in suicidal ideation scores among 3,356 participants across 14 studies, suggesting they may be more effective than simply waiting for treatment.

However, there was no evidence that these interventions reduced self-harm or suicide attempts, and many studies had design biases, indicating that more research is needed to confirm their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online and mobile telephone applications ('apps') for the self-management of suicidal ideation and self-harm: a systematic review and meta-analysis. Witt, K., Spittal, MJ., Carter, G., et al.[2022]

Emphasizing early intervention and ongoing low-intensity contact with individuals at risk of suicide can be more effective than solely focusing on those deemed 'highest risk', suggesting a shift in treatment strategy.

The use of advanced interactive computer programs can enhance screening and training for healthcare providers, improving access to mental health services and continuity of care for suicidal individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. Litman, RE.[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 review of 7 studies on mobile health (mHealth) apps for suicide prevention showed some positive effects, such as reduced depression and increased coping self-efficacy, but none significantly decreased suicidal ideation compared to control groups.

The review highlights the need for more rigorous research and standardized outcome measures in evaluating mHealth interventions, as current studies exhibit methodological limitations that affect their generalizability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. Melia, R., Francis, K., Hickey, E., et al.[2022]

The WellPATH app, used during a 12-week psychotherapy intervention for middle-aged and older adults after suicide-related hospitalization, showed high feasibility and acceptability, with participants and therapists expressing satisfaction with the app.

Case studies indicated that using WellPATH helped patients reduce negative emotions and improve their ability to regulate emotions, suggesting potential benefits for suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Emotion Regulation Tablet App for Middle-Aged and Older Adults at High Suicide Risk: Feasibility, Acceptability, and Two Case Studies. Kiosses, DN., Monkovic, J., Stern, A., 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. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837367

A Digital Therapeutic Intervention for Inpatients With ... Suicide-focused cognitive behavior therapies (CBTs) have been shown to reduce suicidal behaviors by approximately 20% on average compared with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096958/

Digital Interventions for Suicide Prevention This review aimed to determine the effectiveness of digital interventions designed to address suicidal ideation and behaviors and the impacts of age, gender, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06318962

Study Details | NCT06318962 | Examining the Efficacy of a ... The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ...

4. neurologyadvisor.com neurologyadvisor.com/news/suicide-specific-therapy-app-reduces-suicidal-behavior-inpatients-high-risk/

Suicide-Specific Therapy App Effectively Reduces ... The suicide attempt rate among patients with a prior suicide attempt decreased by 14.0 percent for every digital therapeutic module completed. “ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12234914/

a systematic review of digital suicide prevention tools Empirical findings have shown that digital tools decrease suicidal ideation, enhance help-seeking behaviour, and result in better mental health ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124000350

Digital safety plan effectiveness and use: Findings from a ... Among users of a self-guided safety planning app, increases in suicide-related coping uniquely predicted decreases in suicidal ideation. · App-related variables ...