Suicide prevention through a SafetyPlan intervention for patients after a suicide attempt or in a suicidal crisis (SAFETY+): a study protocol of a randomised-controlled trial in acute inpatient psychiatric care.

Abstract

Background: Individuals undergoing acute inpatient psychiatric treatment or who have recently been discharged face an especially elevated risk of suicide. Nevertheless, suicide-specific interventions are still not routinely implemented in inpatient psychiatric care in Germany. Safety plan interventions (SPIs), which involve developing individualised safety plans, have been shown to be highly effective in reducing the number of suicide attempts. Due to their simplicity and low resource requirements, they may be suitable for broad implementation. However, there is currently a lack of evidence regarding their effectiveness in inpatient psychiatric settings in Germany. This study addresses this critical research gap by investigating whether the SAFETY+ intervention can reduce suicide attempts within twelve months of discharge from a German inpatient psychiatric setting compared to usual care. Additionally, the research project will focus on the implementation of the intervention.

Method: This mixed-methods study combines a randomised controlled trial (RCT) with qualitative interviews of participants and professionals involved in treatment and study implementation. In the RCT, 450 patients with acute suicidality will be recruited from three large psychiatric clinics in Bavaria. Participants will be randomly assigned to either the SafetyPlan group (n = 225) or the treatment-as-usual group (n = 225). The intervention includes a manualised SafetyPlan intervention (SPI) session during hospitalisation and telephone follow-up sessions one and four weeks after discharge. Data will be collected at five time points: after consenting to participate (T0a) and shortly before discharge (T0b), as well as at follow-ups six weeks (T1), six months (T2) and twelve months (T3) after discharge.

Discussion: The findings of this study can be transferred directly into standard psychiatric practice since the study is embedded in routine clinical care. The study encompasses both urban areas (Munich) and rural areas with limited outpatient resources (e.g., the Bavarian Forest region, a rural area in Eastern Bavaria), thereby enhancing the generalisability of the results to other psychiatric care settings with similar structures across Germany. Should the procedure prove effective, the findings may promote future nationwide implementation efforts.

Trial registration: This trial is registered with the German Clinical Trials Register (DRKS), ID: DRKS00037168, registered on 07 July 2025. URL: https://www.drks.de/DRKS00037168 .