Highlights
The trial tested a 12‑module smartphone‑delivered suicide‑focused CBT in psychiatric inpatients and was stopped early for futility on the primary end point (time to first actual suicide attempt). Primary outcome did not differ significantly (P = .06). Secondary and sensitivity analyses showed sustained reductions in suicidal ideation through 24 weeks and, in nonprespecified analyses among patients with prior suicide attempts, fewer recurrent attempts (adjusted RR 0.42; 95% CI, 0.18–0.95) and higher clinician‑rated improvement.
Study background and disease burden
Suicide remains a leading cause of death worldwide and a major public health problem in the United States. Hospitalization for suicidal ideation or following an attempt marks a critical period of elevated near‑term risk for repeat self‑harm and suicide. Evidence supports suicide‑focused psychotherapies, particularly cognitive behavior therapy (CBT), in reducing suicidal behavior; however, routine delivery of specialized CBT in inpatient and early postdischarge settings faces logistical, workforce, and cost barriers.
Digital therapeutics—structured, evidence‑based interventions delivered via mobile devices—offer scalable ways to extend access to psychotherapy content, augment traditional care, and support patients through high‑risk transition periods. The trial by Bryan et al. (JAMA Network Open, 2025) evaluates whether a smartphone CBT program designed specifically for suicide prevention can reduce suicidal behavior and ideation in adults admitted to psychiatric inpatient units for suicide attempt or ideation.
Study design
This was a multisite, double‑blind, randomized clinical trial conducted across six psychiatric inpatient units in the US between April 2022 and April 2024. Adults admitted with elevated suicide risk were randomized to one of two smartphone interventions plus treatment as usual: (1) an experimental digital therapeutic comprising 12 short suicide‑focused CBT modules (10–15 minutes each), and (2) an active control application containing 12 sessions of safety planning and psychoeducation about suicide. The first session for both arms was completed before discharge; subsequent sessions were self‑paced after discharge. All participants continued to receive standard inpatient and outpatient clinical care.
The primary end point was time (days) to first actual suicide attempt during follow‑up. Secondary outcomes included change in suicidal ideation from baseline to week 24 (Scale for Suicide Ideation total score) and clinician‑rated clinical improvement at week 24. A nonprespecified sensitivity analysis examined the rate of suicide attempts defined to include actual, aborted, and interrupted attempts. Prespecified subgroup analyses compared patients with and without prior suicide attempts. The trial was stopped early by the data safety monitoring board after crossing a prespecified futility boundary for the primary end point. Analyses followed the intention‑to‑treat principle.
Key findings
Population: 339 participants were randomized (mean age 27.9 years; 66.1% female). Follow‑up data were available for 266 participants (78.5%).
Primary outcome: Time to first actual suicide attempt did not differ significantly between arms (log‑rank χ2 1 = 3.6; P = .06). Although this P value approaches conventional significance, it did not reach the preplanned threshold and the trial was stopped early for futility on this primary outcome.
Secondary outcomes—suicidal ideation: Trajectories of suicidal ideation over 24 weeks differed significantly between groups (F3,206 = 2.9; P = .04). Participants randomized to the digital therapeutic experienced a sustained decrease in suicidal ideation through week 24. In contrast, the control arm showed improvement through week 12 followed by a rise in ideation at week 24. This pattern suggests the CBT content may have longer‑lasting effects on ideation than safety planning/psychoeducation alone.
Subgroup/sensitivity analyses—participants with prior attempts: Among the 170 participants with a history of prior suicide attempts, nonprespecified sensitivity analyses found a substantially lower adjusted rate of follow‑up suicide attempts in the digital therapeutic group versus control (0.70 vs 1.68 attempts per person‑year; adjusted rate ratio 0.42; 95% CI, 0.18–0.95; P = .04), corresponding to a 58.3% relative reduction. Clinician‑rated clinical improvement at week 24 was also higher in the digital therapeutic arm in this subgroup (97.9% vs 87.5%; OR 7.59; 95% CI, 1.14–153.62; P = .04).
Dose‑response: In a nonprespecified dose‑response analysis among patients with prior attempts, each additional digital therapeutic module completed was associated with a 14.0% reduction in suicide attempt rate (adjusted RR 0.86 per module; 95% CI, 0.76–0.98; P = .02), suggesting a plausible relationship between treatment “dose” and clinical benefit.
Safety: The report does not indicate novel safety signals attributable to the digital intervention. Suicide attempts occurred in both arms, and the primary null result implies that the intervention was not associated with clear harm relative to the active control.
Statistical considerations: The trial was terminated early for futility on the primary outcome; early stopping limits power and complicates interpretation of subgroup and nonprespecified analyses. Several significant results (e.g., subgroup effects) derived from nonprespecified or exploratory analyses; these generate hypotheses but require replication in appropriately powered confirmatory trials.
Expert commentary
How should clinicians interpret these findings? The overall null primary outcome tempers enthusiasm for broad deployment of this digital therapeutic as a universal substitute for postdischarge care. However, three clinically relevant signals deserve attention.
1) Sustained ideation reduction: Suicidal ideation is an important proximal target and a treatment metric clinicians can monitor. An intervention that sustains reductions in ideation through 24 weeks addresses a key gap in the early postdischarge period when relapse risk is high.
2) Signal among higher‑risk patients: The pronounced reduction in recurrent attempts among those with prior attempts—albeit identified in nonprespecified analyses—aligns with the evidence that prior attempt history is the strongest single predictor of future attempts. If replicated, this digital CBT approach could be prioritized as an adjunctive relapse‑prevention strategy for patients with a history of attempts.
3) Dose‑response relation: The observed per‑module benefit suggests that adherence and completion matter. Implementation strategies that support engagement (e.g., clinician monitoring, reminders, blended care models) may enhance effectiveness.
Limitations highlighted by experts include early stopping and potential multiplicity: subgroup and sensitivity analyses carry a higher risk of false positives. The control condition was active—safety planning and psychoeducation—which itself is clinically effective; this reduces the likelihood of large between‑group differences. Missing data (≈21.5% without follow‑up) and the young, predominantly female sample may limit generalizability.
Mechanistic plausibility: Suicide‑focused CBT targets cognitive patterns (hopelessness, problem‑solving deficits) and behavioral skills (emotion regulation, coping strategies) that can reduce suicidal ideation and behavior. Digitally delivered modules can reinforce learning, provide on‑demand coping tools, and bridge outpatient care gaps after discharge—mechanisms consistent with the sustained ideation improvements observed.
Clinical implications and implementation considerations
For practicing clinicians, the trial suggests that a structured smartphone CBT program can be safely integrated as an adjunct to standard inpatient discharge planning. Practical points:
– Targeting: Consider prioritizing digital CBT for patients with prior suicide attempts or those who demonstrate willingness and capacity to engage with smartphone modules.
– Blending care: Combining digital modules with scheduled clinician check‑ins, safety planning, and rapid outpatient linkage may maximize adherence and effectiveness.
– Monitoring: Track engagement (module completion), changes in ideation scores, and any emergent safety concerns. Use digital interventions as augmentative tools, not replacements for clinical assessment and crisis management.
– Equity and access: Ensure device access, privacy safeguards, and culturally appropriate content; address digital literacy barriers.
Limitations and research priorities
Key limitations that future studies should address include early termination and consequent reduced statistical power, reliance on nonprespecified analyses to support subgroup effects, and moderate loss to follow‑up. Future research priorities:
– Replication in a larger, adequately powered randomized trial with prespecified stratification by prior attempt history.
– Comparative effectiveness studies contrasting digital CBT with therapist‑delivered CBT and blended models.
– Implementation trials focused on engagement strategies, equity of access, and integration within inpatient‑to‑outpatient transitions.
– Economic analyses to quantify cost‑effectiveness and potential health‑system benefits from reduced recurrent attempts.
Conclusions
This rigorously conducted multisite RCT did not show a statistically significant effect of a 12‑module smartphone CBT program on time to first actual suicide attempt in the overall inpatient sample. Nevertheless, the intervention produced sustained reductions in suicidal ideation through 24 weeks and demonstrated a clinically meaningful reduction in recurrent suicide attempts among patients with prior attempts in exploratory analyses. The dose‑response relationship between module completion and reduced attempts supports the plausibility of a real treatment effect contingent on engagement.
Clinicians should view the digital therapeutic as a promising adjunct for high‑risk inpatients—particularly those with prior attempts—while recognizing that confirmatory trials are needed before widespread adoption as a primary preventive strategy. In the interim, integrating structured digital CBT into a comprehensive discharge plan, with attention to engagement and safety monitoring, may offer a practical way to extend evidence‑based care during a vulnerable period.
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
Brown GK, Ten Have T, Henriques GR, et al. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005;294(5):563–570. doi:10.1001/jama.294.5.563
World Health Organization. Suicide worldwide in 2019: global health estimates. Geneva: WHO; 2021. Available at: https://www.who.int/publications/i/item/9789240026643
AI image prompt (for editorial illustration)
A compassionate inpatient psychiatry scene: a clinician and an adult patient seated near a hospital bed, clinician presenting a smartphone with a clean user interface showing CBT modules and a safety plan; soft natural light, calming color palette (muted blues and warm neutrals), subtle hospital environment in the background, photorealistic, high detail — suitable for a medical journal cover.
