Suicide is a major killer in the United States and the rates have gone higher by over 30 percent since 1999. More than 1 million adults do nonfatal suicidal behavior each year. The immediate time after psychiatric hospitalization is one of the most high risk periods during which committing suicide occurs, and it is vital to determine the measures that can be adopted to minimize relapse and prevent fatalities.
Conventional suicide-oriented cognitive behavioral therapy (CBT) has persistently proved to be effective in lowering the suicidal actions, in some cases by lowering repeat attempts by up to 40-60%. Nevertheless, the uptake has been restricted, especially because of training requirements, a shortage of clinicians, and resource constraints. Digital therapeutics, i.e., software-based medical interventions, provide a possible remedy since they provide evidence-based care on scale.
A randomized clinical trial published in JAMA Network Open (August 2025) was used to investigate the potential of a smartphone based digital therapeutic to provide suicide oriented CBT to reduce suicide attempts among high-risk psychiatric inpatients.
Study Overview
The trial was conducted among 339 adult psychiatric inpatients in six hospitals in the U.S. starting in April 2022 and ending in April 2024. The subjects had all either had a recent suicide attempt or active suicidal ideation.
Design: Randomized clinical trial in a blinded fashion.
Digital therapeutic app (OTX-202): 12 self-guided modules, 10-15 minutes, instructing skills of suicide-focused CBT like crisis planning, emotion regulation, and cognitive reappraisal.
Control app: An app with a similar look, which provides safety planning and general psychoeducation, lacking specifically aimed CBT skills.
Treatment-as-usual (TAU), which consisted of clinician assessment, safety planning, crisis resources and outpatient referrals, was also given to both groups.
Time to first actual suicide attempt following hospital discharge was the main outcome of trial. Additional effects such as modifications in suicidal thinking and clinical severity measured by clinicians were the secondary outcomes.
Key Findings
Primary Outcome: No Difference in Time to First Attempt
During interim analysis, there were 266 participants with follow up information. Approximately 11.7 percent attempted suicide on follow up. There was no significant difference between the digital therapeutic and control groups in terms of the rate.
Secondary Outcomes: Decreased Suicidal ideation
Suicidal patterns of the thought varied across groups:
Digital therapeutic group: Suicidal thought declined gradually with the baseline up to week 24.
Control group: The ideation dropped till week 12 and then increased in week 24.
This is an indication that the digital CBT app aided in maintaining long-term decreases in suicidal ideation when compared to conventional psychoeducation.
Subgroup Findings: Stronger Benefits for High-Risk Patients
In patients with the history of past suicide attempts, extra advantages appeared:
Repeat attempts were reduced by 58.3 percent as compared to the control group.
Reduces suicide attempts rate by 14 percent with the completion of a module.
Higher odds of clinician-rated improvement (97.9% vs. 87.5%).
This suggests that digital therapeutics could be of the greatest influence to patients with risk profiles, as well as chronic conditions.
Why It Matters
Removing Access Barriers
CBT that is suicide-oriented is effective but it has been difficult to scale it in a clinical setting. Online therapeutics offer:
Scalability: Apps are able to access a large number of patients without having to use therapist time intensively.
Fidelity: Evidence based protocols are presented on a regular basis.
Accessibility: Patients are able to interact at their own time, even in the post-discharge.
Recovery Maintenance Outside Hospital Walls
The trial also shows an essential advantage: although hospital care is essential in terms of immediate safety, recovery requires post-discharge support. A smartphone-based application can serve as a bridge at this critical time and can be used by patients to practice skills and deal with crisis situations outside the clinical environment.
Reaching the Right Patients.
It is interesting to note that the intervention produced the biggest effect on patients who had had previous attempts, the ones who were most vulnerable of recurrence. This implies that individualized targeting may be maximized.
Limitations of the Study
The authors identify some caveats:
Termination of trials early: The project was halted at interim analysis because of futility on the primary outcome in the sense that less data was gathered than was planned.
Low involvement: The average number of modules completed by patients was also 4 out of 12, which restricted the possible benefits.
Broad inclusion criteria: The majority of follow-ups suicide attempts were among patients who had previously attempted suicide, and thus the findings were less generalizable to less-at-risk inpatients.
Digital access: Patients who lacked access to smart phones were not allowed.
Notwithstanding these difficulties, the presented advantages of high-risk populations are promising and should be investigated.
Conclusion
The trial is a 2025 first of a kind attempt to rigorously test a digital therapeutic app in suicide prevention in psychiatric inpatients. Although the intervention did not decrease the time to first attempt among all study participants, it:
Long term decrease of suicidal thoughts,
Cut recurrent suicide attempts by over half among patients with prior attempts, and
Clinician-rated outcomes are improved among individuals at higher risk.
Digital therapeutics are not a one size fits all answer but can be an effective complement to conventional care, especially to patients who are leaving inpatient care to outpatient care. Refined, higher levels of patient involvement and embedded in clinical processes, these tools can be fundamental in tackling one of the most pressing challenges in the health of the population of our era.
Reference
Bryan CJ, Simon P, Wilkinson ST, et al. A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk: A Randomized Clinical Trial. JAMA Network Open. 2025;8(8):e2525809. doi:10.1001/jamanetworkopen.2025.25809