About this trial
Background: Suicidal behavior represents a major public health problem worldwide. According to the World Health Organization (WHO), approximately 720.000 people die by suicide annually, and many more attempt it. Suicide is a personal tragedy associated with extreme suffering that has a serious impact on the deceased's immediate circle and on society as a whole. In this context, there is an urgent need to design effective and humane intervention strategies that offer an evidence-based, preventive, specialized, and community-oriented response to suicidal behavior.
Objective: To evaluate the impact of a multidisciplinary, specialized, and high-resolution program for the prevention of suicidal behavior in adults aged 18 and over in the Salamanca Health Area.
Methods: A quasi-experimental, ambispective cohort study with two parallel groups: an intervention group, receiving the specific suicide prevention program (SPP) with a pre-test/post-test design, and a control group, receiving usual care (TC). Adult patients (≥ 18 years) will be referred from the Emergency Department of the University Hospital of Salamanca after an initial psychiatric evaluation. Patients will be assigned to the intervention group according to established inclusion criteria. The program lasts 3 months, during which each participant will receive intensive and individualized follow-up from a multidisciplinary team composed of two psychiatrists, two mental health nurses, two psychologists, and two social workers at two community mental health centers. Participants will also attend 10 weekly group therapy sessions. Follow-up evaluations will be conducted at the end of the program (three months) and six months after the first contact.
Discussion: This study will contribute to the scientific evidence base on the effectiveness of intensive and specific suicide prevention programs in the community setting, optimizing healthcare resources, improving treatment adherence, and aligning with the Spanish National Suicide Prevention Plan 2025-2027. Ethics and dissemination: This study has been approved by the Clinical Research Ethics Committee of the Salamanca Health Area (CEIm code: PI 2025 11 2102 - TD)
Keywords: Suicidal behavior; Suicide prevention; Suicidal ideation; Community mental health services; Quasi-experimental study; Cohort study; Psychiatric emergency services; Patient care team.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age.
No prior active follow-up by the mental health team.
Prior stabilization by the emergency psychiatry team.
Columbia Severity Rating Scale (C-SSRS) score corresponding to moderate-to-high risk.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
PPS; SUICIDE PREVENTION PROGRAM
BehavioralThe Suicide Prevention Program (PPS) is a high-resolution, outpatient program delivered by a multidisciplinary team consisting of two mental health nurses, two psychiatrists, two psychologists, and two social workers. It operates in two community mental health centers in Salamanca, belonging to the Specialized Care Management, over a three-month period. The first contact with the patient will be made by telephone within 24 hours of referral by a mental health nurse. The first in-person appointment will take place in a nursing consultation within 72 hours. The patient will have a maximum of 72 psychiatric appointments, a maximum of seven days for the first appointment with a psychologist, and a maximum of 14 days for the first appointment with a social worker. The program also includes 10 group sessions, in-person and telephone follow-up, and crisis intervention.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of Clinically Significant Suicidal Behavior
Proportion of participants experiencing at least one clinically significant suicidal event during follow-up, defined as: (1) a new suicide attempt documented in the emergency department or clinical records; (2) urgent psychiatric hospitalization in a Short-Stay Inpatient Unit (UHB) due to suicidal behavior; or (3) completed suicide. Assessment Tool: Prospective registry via electronic clinical records (SACYL). For suicide attempts: emergency department records. For hospitalizations: inpatient admission records. For completed suicide: civil registry and/or clinical team notification. Scale: Dichotomous outcome (presence/absence of recurrence) and discrete quantitative variable (number of events: 0, 1, 2, 3...).
Secondary outcomes
Type of Suicidal Behavior
Measure: Method or type of suicidal behavior at index episode. Assessment Tool: Clinical records (emergency department psychiatric assessment). Scale: Categorical: 1. Suicidal ideation · 2. Drug overdose · 3. Chemical intoxication · 4. Gas inhalation · 5. Venipuncture · 6. Defenestration · 7. Firearm · 8. Sharp object · 9. Self-induced asphyxia.
Suicidal Ideation Severity.
Measure: Severity of suicidal ideation at baseline, end of program, and 12-month follow-up. Assessment Tool: Columbia Suicide Severity Rating Scale (C-SSRS) - Spanish validated version (Giner et al., 2014). Clinician-administered scale with 6 items assessing the type and intensity of suicidal ideation and suicidal behavior. High sensitivity and specificity for suicidal risk stratification. Scale: 0 = No risk · 1 = Low (C-SSRS 1-2) · 2 = Moderate (C-SSRS 3-5) · 3 = High (C-SSRS ≥6).
Emergency Department Visits due to Suicidal Ideation
Measure: Number of emergency department episodes motivated exclusively by new suicidal ideation (without suicide attempt) during follow-up. Assessment Tool: Electronic clinical records (SACYL). Scale: Discrete quantitative variable (number of episodes: 0, 1, 2, 3...).
Global Clinical Impression of Suicidal Risk - Severity (CGI-SS-S)
Measure: Clinician-rated global severity of suicidal risk at baseline, end of program, and 12-month follow-up. Assessment Tool: Clinical Global Impression - Suicide Scale (CGI-SS). Clinician-administered 7-point scale specifically designed for the global clinical evaluation of suicidal risk. Assesses severity at a given time point (CGI-SS-S) and improvement or worsening relative to the previous assessment (CGI-SS-I). Widely used in clinical trials on suicidal behavior. Scale: 0 = Not assessed · 1 = Normal · 2 = Borderline ill · 3 = Mildly ill · 4 = Moderately ill · 5 = Markedly ill · 6 = Severely ill · 7 = Extremely ill.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Salamanca
Lead sponsor
Sanidad de Castilla y León
Collaborator