Digital Therapeutic for Suicide Prevention

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

356 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a digital program designed to help people reduce their risk of attempting suicide. It involves 391 participants who are at risk of suicide. The program offers tools and support to help them manage their thoughts and feelings.

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 data supports the effectiveness of the treatment Digital Therapeutic for suicide prevention?

Research shows that digital interventions, including apps and online programs, can help reduce suicidal thoughts and behaviors by providing psychological self-help to those who might not seek traditional health services. These tools can be particularly effective when they target both direct issues like suicidality and related conditions such as depression. ^{1 2 3 4 5}

What safety data exists for digital therapeutics in suicide prevention?

Digital interventions for suicide prevention, like mobile apps, are being studied for their safety and effectiveness. However, there is a lack of consistent definitions and reporting of adverse events (unwanted effects) in these studies, making it hard to fully assess their safety. Some apps, like WellPATH, have shown feasibility and acceptability in helping people manage emotions, but more research is needed to ensure safety across different populations. ^{2 4 6 7 8}

How is the Digital Therapeutic treatment for suicide prevention different from other treatments?

The Digital Therapeutic treatment for suicide prevention is unique because it uses mobile devices and apps to deliver psychological support, making it accessible to individuals who may not seek traditional health services. This approach allows for personalized, on-demand interventions that can be accessed remotely, which is particularly beneficial for those in isolation or with limited access to in-person care. ^{1 2 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Other App + Treatment as Usual Experimental Treatment 1 Intervention

This intervention will be for the control group

Group II: Experimental App + Treatment as Usual Experimental Treatment 1 Intervention

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Suicide prevention using self-guided digital interventions: a systematic review and meta-analysis of randomised controlled trials. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. [2022]

4. England 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. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of digital cognitive behavioral therapy for depression on suicidal thoughts and behavior: Protocol for a systematic review and meta-analysis of individual participant data. [2023]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Suicide prevention and depression apps' suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Codesign of a digital health tool for suicide prevention: protocol for a scoping review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Remote blended treatment for individuals with suicidal ideation: A single-arm proof-of-concept trial. [2023]