Suicide prevention through a SafetyPlan intervention for patients after a suicide attempt or in suicidal crises (SAFETY+)

Suicide prevention through a SafetyPlan intervention for patients after a suicide attempt or in suicidal crises (SAFETY+) - SAFETY+

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037168

Enrollment

450

Registered

2025-07-07

Start date

2025-07-14

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidality, suicide attempts, suicidal crisis

Interventions

Group 1: The SAFETY+ program includes (for individuals assigned to the intervention group) a manualized SafetyPlan therapy session (Stanley & Brown, 2012), in which an emergency plan is created before

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. inpatient admission to the clinic due to/as a result of a suicide 2. adequate knowledge of German 3. the willingness to participate in the study aftere being fully informed

Exclusion criteria

Exclusion criteria: 1. the lack of capicity to consent 2. lethal prognosis due to a physical illness 3. mental disability/minor aptitude 4. existing diagnosis of dementia (F00-F03, ICD-10)

Design outcomes

Primary

Measure	Time frame
The primary outcome is the number of patients per group who have made (at least) one further suicide attempt within 12 months after baseline. The included patients are contacted by telephone 6 weeks (T1), 6 months (T2) and 12 months (T3) after their discharge from the inpatient area and - with the help of the Self-injurious Thoughts and Behaviors Interview (SITBI, Fisher et al., 2014) - asked about the recurrence of suicide attempts. Suicide attempts are considered the best proxy measure for suicide in suicide prevention research (Bryan & Rudd, 2018) and are therefore the most common and important outcome measure in suicidality-related intervention research (see e.g. Brown et al, 2005; Bryan et al, 2017, 2024; Calati & Courtet, 2016; Fox et al, 2021; Gotsche & Gotsche, 2016; Gysin-Maillart et al, 2016; Rudd et al, 2015; Stanley et al, 2018; Sobanski et al, 2021). With this in mind - and to ensure comparability with the relevant literature - the occurrence of (at least) one suicide attempt during the study period is defined as the primary outcome measure. Other suicide-associated measures are recorded as secondary outcome measures. In addition, the participating patients are asked for their consent upon inclusion in the study that, if they cannot be contacted at T1, T2 and/or T3, their primary care physicians or relatives may also be contacted.	—

Measure

Time frame

The primary outcome is the number of patients per group who have made (at least) one further suicide attempt within 12 months after baseline. The included patients are contacted by telephone 6 weeks (T1), 6 months (T2) and 12 months (T3) after their discharge from the inpatient area and - with the help of the Self-injurious Thoughts and Behaviors Interview (SITBI, Fisher et al., 2014) - asked about the recurrence of suicide attempts. Suicide attempts are considered the best proxy measure for suicide in suicide prevention research (Bryan & Rudd, 2018) and are therefore the most common and important outcome measure in suicidality-related intervention research (see e.g. Brown et al, 2005; Bryan et al, 2017, 2024; Calati & Courtet, 2016; Fox et al, 2021; Gotsche & Gotsche, 2016; Gysin-Maillart et al, 2016; Rudd et al, 2015; Stanley et al, 2018; Sobanski et al, 2021). With this in mind - and to ensure comparability with the relevant literature - the occurrence of (at least) one suicide attempt during the study period is defined as the primary outcome measure. Other suicide-associated measures are recorded as secondary outcome measures. In addition, the participating patients are asked for their consent upon inclusion in the study that, if they cannot be contacted at T1, T2 and/or T3, their primary care physicians or relatives may also be contacted.

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Secondary

Measure	Time frame
Secondary outcome measures are (1.) the frequency of suicide attempts (recorded with the SITBI), (2.) the number of suicides (contacting family doctors/relatives), (3.) suicidal thoughts, suicidal plans, suicidal gestures, non-suicidal self-harm (recorded with the SITBI and the SSEV, see below), (4.) suicide-related cognitive constructs (recorded with the SCS, the PTSQ and the SAS, see below) and the use of suicide-specific interventions (see below). below), (4.) suicide-associated cognitive construct (assessed with the SCS, the PTSQ and the SAS, see below) and the use of suicide-specific interventions and services in the 12 months after baseline. In addition, the hospital records of all participating clinics will be reviewed for readmission (due to suicidality) within 12 months after the intervention.	—

Measure

Time frame

Secondary outcome measures are (1.) the frequency of suicide attempts (recorded with the SITBI), (2.) the number of suicides (contacting family doctors/relatives), (3.) suicidal thoughts, suicidal plans, suicidal gestures, non-suicidal self-harm (recorded with the SITBI and the SSEV, see below), (4.) suicide-related cognitive constructs (recorded with the SCS, the PTSQ and the SAS, see below) and the use of suicide-specific interventions (see below). below), (4.) suicide-associated cognitive construct (assessed with the SCS, the PTSQ and the SAS, see below) and the use of suicide-specific interventions and services in the 12 months after baseline. In addition, the hospital records of all participating clinics will be reviewed for readmission (due to suicidality) within 12 months after the intervention.

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Countries

Germany

Contacts

Public ContactMariam Yunusah

Bezirksklinikum Mainkofen

m.yunusah@mainkofen.de+49 9931 87 21757

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 6, 2026