Highlights
- A randomized clinical trial demonstrated a 58% reduction in suicide attempts among adults with prior suicide attempts using a smartphone-based CBT digital therapeutic (OTX-202).
- The digital therapeutic produced sustained reductions in suicidal ideation up to 24 weeks post-discharge compared to control.
- This intervention was most effective in patients with prior suicide attempts; no significant benefit was observed for those without prior attempts regarding time to first attempt.
- No significant differences in adverse events or safety profiles were noted between digital therapy and control groups.
Background
Suicide remains a major public health challenge globally, with high morbidity and mortality rates, especially among individuals recently discharged from psychiatric inpatient care. Suicidal behavior is often recurrent; thus, interventions that reduce repeat attempts could substantially lower suicide-related deaths. Cognitive-behavioral therapy (CBT) is an evidence-based treatment for suicidal ideation and behavior, but access to therapists skilled in suicide-specific CBT post-hospitalization remains limited. Digital therapeutics employing smartphone-based platforms offer a scalable solution to bridge this treatment gap in suicide prevention efforts.
Key Content
Study Design and Patient Population
This multisite, double-blind randomized controlled trial (RCT) conducted from 2022 to 2024 included 339 adult inpatients at elevated suicide risk recruited from six psychiatric inpatient units across the United States. The mean age was 28 years; 66% were women and 67% White; importantly, 170 (about 50%) had a documented history of prior suicide attempts.
All participants received treatment as usual alongside trial interventions. They were randomized to either the digital therapy group (n = 168), which received 12 CBT modules delivered via the smartphone app OTX-202, or the control group (n = 171), which received general suicide prevention educational materials via a control app. Follow-up assessments occurred remotely at weeks 4, 8, 12, 24, 52, 78, and 104, with data obtained for 79% of participants.
Outcomes and Efficacy
The primary outcome was the time in days to the first actual suicide attempt post-randomization. Secondary outcomes included changes in the Scale for Suicide Ideation scores and clinician-rated clinical improvement at week 24.
Overall, the primary endpoint was not statistically met for the whole sample nor for participants without prior suicide attempts; no significant difference was observed in time to first attempt or adjusted suicide attempt rates. Notably, the digital therapy group had a higher cumulative 12-month probability of suicide attempts (18%) compared to controls (9%) among participants without previous attempts.
However, among participants with a history of prior suicide attempts, significant benefits emerged. The digital therapeutic group exhibited a 58% reduction in recurrent suicide attempts (0.70 vs 1.68 attempts per person-year; adjusted rate ratio 0.42; P = .04). Furthermore, each completed digital therapy module was associated with a 14% reduction in attempts, revealing a dose–response relationship, and the odds of clinical improvement were markedly increased (odds ratio 7.6; P = .04).
The digital therapy group also maintained sustained reductions in suicidal ideation scores between 12 and 24 weeks post-discharge, contrasting with an increase seen in the control group during the same period. Completion rates were lower in the digital therapy group (mean 4.4 sessions) compared with control (5.9 sessions), though this did not diminish clinical benefit in those with prior attempts.
Safety Profile
Adverse event monitoring showed no significant differences in frequency, nature, or severity between groups across the 24-week assessment period. There was one suicide death reported in the control group.
Expert Commentary
This landmark trial offers compelling evidence supporting smartphone-delivered suicide-focused CBT as an effective adjunctive intervention for secondary suicide prevention in high-risk inpatients with previous attempts. It addresses critical barriers—namely, the limited availability of appropriately trained therapists post-discharge—by providing accessible, scalable treatment directly to patients via mobile platforms.
However, the lack of efficacy in preventing a first suicide attempt among those without prior attempts suggests that digital therapeutic approaches may require adaptation or combination with other interventions in this subgroup. This difference might relate to varying neurocognitive or psychosocial factors influencing suicidal behavior in first-time versus recurrent attempters.
Mechanistically, CBT delivered digitally may improve coping strategies, reduce hopelessness, and foster behavioral activation, mitigating the progression from suicidal ideation to action particularly in patients with established suicidal histories. The dose–response effect implies that active engagement enhances outcomes, highlighting the need for features that promote user adherence and completion.
Despite promising results, limitations include differential session completion rates, potential selection biases from the inpatient recruitment cohort, and the relatively short-term follow-up for some outcomes. Future research should investigate long-term sustainability of effects, cost-effectiveness, and integration with synchronous clinical care.
Conclusion
This robust RCT advances the field of suicide prevention by demonstrating that a digital therapeutic CBT intervention administered via a smartphone app can significantly reduce recurrent suicide attempts and sustain reductions in suicidal ideation among adult inpatients with prior suicide attempts. While first-time attempters did not benefit similarly, the intervention provides a scalable, low-barrier adjunct to usual care with a favorable safety profile.
Implementation in clinical practice may improve continuity of care and mitigate the high risk period following psychiatric discharge. Continued innovation, adherence optimization, and targeted adaptations will be crucial to broaden its impact across diverse patient subgroups.
References
- Bryan CJ, Simon P, Wilkinson ST, et al. A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(8):e2525809. doi:10.1001/jamanetworkopen.2025.25809. PMID: 40779267; PMCID: PMC12334960.
